Dorsey Health Law

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Alex Hartzell for the following post on the FCA Now blog: The Department of Justice (“DOJ”) last month announced a new blockbuster settlement agreement under the False Claims Act, 31 U.S.C. § 3729 et seq (“FCA”), involving alleged violations of the Stark law and other efforts to defraud federal and state healthcare programs. The agreement also resolved the government’s allegations that the defendants—having allegedly engaged in healthcare fraud—further violated the FCA by obtaining a loan through the Paycheck Protection Program (“PPP” or “Program”) while certifying they were not engaged in illegal activities. Although this settlement appears principally to address allegations of healthcare fraud, the resolution of FCA claims involving alleged PPP fraud highlights the government’s efforts to root out those who attempt to defraud COVID-19 relief programs. Read more here.

There is a lot going on right now for healthcare employers.  The first phase of CMS’s vaccine mandate is in full effect nationwide (now including Texas), the CDC has changed masking guidance in some circumstances, and it has been two months since OSHA let the Health Care Emergency Temporary Standard expire.  To help you navigate where things stand, we’ve provided an update on each of those topics below. CMS Vaccine Mandate On November 4, 2021, CMS enacted an Interim Final Rule (“IFR”) requiring staff at certain Medicare or Medicaid providers and suppliers (“Covered Healthcare Employers”) to be fully vaccinated against COVID-19 unless they qualify for a medical or religious exemption.  That rule was temporarily enjoined in 25 states on November 29, 2021.  On January 13, 2022, the Supreme Court lifted the temporary injunction.  Thus, Covered Healthcare Employers nationwide have an obligation to ensure that staff (defined broadly by the IFR) are vaccinated against COVID-19 or risk citation from CMS.  See our prior blog post on this topic for more details about the IFR. The IFR broadly defines the term “staff” to include “facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement.” The fact that care may not be provided in a formal clinical setting does not relieve staff from the mandate.  How frequently a person physically enters a Covered Healthcare Employer’s setting is also irrelevant.  Only those staff who perform 100 percent of their work remotely (for example, telehealth or payroll) are fully exempt from the vaccine mandate. Note that the IFR’s definition of “staff” includes those providing services “under contract or other arrangement.”  That means, to demonstrate compliance with the IFR, Covered Healthcare Employers must be able to establish that contract staff (for example, from agencies or locum providers) are fully vaccinated against COVID-19 or have approved medical or religious exemptions from the vaccine.  Covered Healthcare Employers must have access to documentation regarding the vaccinations of the contract employees, or approved exemptions, during a compliance survey. CMS has previously stated that Covered Healthcare Employers are not expected to maintain on-site physical copies of proof of vaccination or exemption for contractors. Because of that, some Covered Healthcare Employers used attestation forms to verify the vaccination status of contracted employees or included vague language in contracts such as, “Agency will provide vaccinated employees to provider organization.”  CMS has clarified that, if used, an attestation must be specific, and a blanket attestation will not be sufficient. CMS provided the following examples: Acceptable: “Staff X is fully vaccinated against COVID-19” or “Staff Y has been granted an exemption that meets the requirements of the rule.” Unacceptable: “Contracting organization X will send to provider organization Y only staff who are either fully vaccinated or who have been granted an exemption that meets requirements of the rule.” Because all Covered Healthcare Employers must be able to obtain and submit to surveyors proof of vaccination status and information regarding exemptions and accommodations for all staff (as defined by the IFR) upon request, Covered Healthcare Employers should include COVID-19 vaccination language in new contracts and amend existing contracts to include such language. Changes to the CDC’s Masking Guidance On February 25, 2022, the CDC (once again) revised its masking guidance.  Now, regardless of vaccination status, individuals are advised to consult the CDC’s COVID-19 Community Level data to help guide masking decisions.  That guidance, however, does not apply in healthcare settings.  Rather, healthcare entities should continue to use the COVID Data Tracker.  Specifically, the CDC states: CDC’s new COVID-19 Community Levels recommendations do not apply in healthcare settings, such as hospitals and nursing homes. Instead, healthcare settings should continue to use community transmission rates and continue to follow CDC’s infection prevention and control recommendations for healthcare settings. This has caused a bit of whiplash for healthcare employers, who may have employees asking why masks are still required if community levels are “Low.”  The simple explanation is that the COVID Data Tracker utilizes different metrics, so even though community levels may be “Low,” community transmission may be “High,” thus requiring continued masking in healthcare settings.  We anticipate clarification and/or further changes may be coming from the CDC, but for now, healthcare entities must continue to follow the masking guidance based on the COVID Data Tracker. Expiration of the OSHA Emergency Temporary Standard  OSHA’s ETS expired on December 21, 2021.  On December 27, 2021, OSHA issued a statement that included the following explanation: OSHA announces today that it intends to continue to work expeditiously to issue a final standard that will protect healthcare workers from COVID-19 hazards, and will do so as it also considers its broader infectious disease rulemaking. However, given that OSHA anticipates a final rule cannot be completed in a timeframe approaching the one contemplated by the OSH Act, OSHA also announces today that it is withdrawing the non-recordkeeping portions of the healthcare ETS. The following are the recordkeeping portions of the healthcare ETS that covered employers must still follow: establishing and maintaining a COVID–19 log to record each instance identified by the employer in which an employee is COVID–19 positive, regardless of whether the instance is connected to exposure to COVID–19 at work; making records available upon request for examination and copying, including all versions of the employer’s written COVID-19 policy, the individual COVID-19 log entry for a particular employee, a version of the COVID-19 log that removes employee identifying information; and reporting COVID–19 fatalities and hospitalizations to OSHA. With the expiration of OSHA’s ETS, healthcare employers are no longer required—under the ETS—to screen employees for COVID-19.  However, that does not necessarily mean that employers should stop screening altogether.  It is prudent for healthcare employers to continue some level of a screening process to ensure compliance with OSHA’s general duty clause, which requires all employers to provide a work environment “free from recognized hazards that are causing or are likely to cause death or serious physical harm.”  (Recall that when OSHA issued the ETS for healthcare employers, it identified COVID-19 as a recognized hazard).  While screening won’t guarantee that employees will avoid catching COVID-19 at work, ongoing screening for the duration of the public health emergency will serve an important role in demonstrating an employers’ mitigation strategies in the event an employer is audited or must respond to an OSHA complaint. This approach of ongoing screening is further underscored by the following from OSHA’s December 27, 2021, statement, in which OSHA encouraged employers “to continue to implement the ETS’s requirements in order to protect employees from a hazard that too often causes death or serious physical harm to employees.” What Should Healthcare Employers Do? Healthcare employers should consider the following practices: Include language in agency or other contractor agreements that addresses CMS’s vaccine mandate, and/or amend existing agreements. Follow CDC masking guidance for healthcare facilities. Continue to screen for COVID-19. Dorsey’s employment and health care attorneys will continue to monitor the developments related to COVID-19 requirements, and will update our health law blog with changes.  Feel free to reach out to the authors or to your regular Dorsey attorney if you have any questions about the vaccine mandate, language for agency or other contractor agreements, screenings, OSHA obligations and record keeping.

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Stephen Lucke, Melinda Maher, Katie Ervin Carlson and Flossie Neale for the following article: Although large employers are no longer subject to OSHA’s vaccine-or-test mandate, some may choose to require testing on their own. There are a number of factors employers must consider in determining whether to voluntarily implement a vaccine-or-test policy for employees. One significant factor for self-funded employers is who pays for testing under such policies. In this article, published earlier this month by Bloomberg Law, we summarize current laws and regulations governing payment of both “over the counter” and traditional Covid-19 tests. Among other things, employers who wish to cover such should consider compliance issues, and self-funded employers should consider how testing costs may affect their health care spend. Read More >

Health care employers are not alone in feeling overwhelmed by the constantly changing legal status of the various federal vaccine mandates.  On Thursday afternoon, the Supreme Court made its rulings on two preliminary challenges to workplace mandates related to the COVID-19 pandemic: the Occupational Safety and Health Administration (OSHA)’s Emergency Temporary Standard (ETS) for large employers (100+ employees), and the Centers for Medicare and Medicaid Services (CMS) vaccine mandate for health care employers.  This article focuses on the current status of CMS’s Interim Final Rule (IFR), issued on November 4, 2021.  The IFR detailed staff vaccination requirements as a condition of receipt of Medicare or Medicaid funds.  CMS estimated that there would be more than 180 million staff, patients, and residents employed or treated at facilities covered by the rule. Legal Challenges to CMS’s Vaccine Mandate On November 29, 2021, a federal court in Missouri stayed the CMS vaccine mandate in Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.  On December 15, 2021, a federal court in Louisiana stayed the CMS rule for fourteen additional states: Louisiana, Montana, Arizona, Alabama, Georgia, Idaho, Indiana, Mississippi, Oklahoma, South Carolina, Utah, West Virginia, Kentucky and Ohio.  Therefore, at that time, the CMS rule was on hold in the 25 (referred to in this article as the “injunction states”) and enforceable in the rest of the country (referred to in this article as the “non-injunction states”).  A few days later, though, CMS indicated that it would temporarily halt enforcement nationwide. The next day, the federal government filed a Petition asking the Supreme Court to lift the CMS IFR stay in the 25 injunction states.  The Supreme Court heard oral arguments on that Petition, as well as whether the OSHA ETS nationwide stay, on January 7, 2022. The Supreme Court’s Ruling On January 13, 2021, the Supreme Court overturned the stay of the CMS vaccine mandate in the injunction states in a 5-4 decision. In the ruling, a majority of Supreme Court justices held that CMS’s IFR “fits neatly within the language of the statute” that authorizes the Secretary of Health and Human Services to impose conditions on the receipt of Medicare and Medicaid funding that are “necessary in the interest of the health and safety of individuals who are furnished services.”  This includes other vaccination requirements, such as hepatitis B, influenza, and measles, mumps, and rubella. The court focused on the fact that those seeking health care services at this time are likely more susceptible to contracting the COVID-19 virus, and stated: [E]nsuring that providers take steps to avoid transmitting a dangerous virus to their patients is consistent with the fundamental principle of the medical profession: first, do no harm. It would be the “very opposite of efficient and effective administration for a facility that is supposed to make people well to make them sick with COVID–19.” For their part, the dissenting justices were concerned with a federal agency forcing health care workers to choose between getting a vaccine that they have thus far failed to receive and remaining employed.  In addition, the dissent disapproved of CMS’s decision to issue the vaccine mandate prior to receiving and addressing public comments. Finally, the dissent took issue with the federal government getting involved in an issue (vaccine mandates) typically reserved for states.  According to the dissent, “[i]f Congress had wanted to grant CMS authority to impose a nationwide vaccine mandate, and consequently alter the state-federal balance, it would have said so clearly.  It did not.”  Somewhat in response to that argument, the majority cautioned that while federal agencies’ ability to exercise their powers is not limitless, “such unprecedented circumstances provide no grounds for limiting the exercise of authorities that the agency has long been recognized to have.” With the majority of the Supreme Court voting to lift the stay, the CMS IFR is back on. CMS Guidance Regarding its Vaccine Mandate Prior to the ruling (on December 28, 2021), CMS issued QSO-22-07-ALL, Guidance for the Interim Final Rule.  That guidance essentially rescinded CMS’s temporary halt on nationwide enforcement of the IFR and established compliance deadlines and additional guidance for covered facilities operating in the non-injunction states.  The Guidance included provide-specific instructions for each type of facility covered by the CMS IFR (for example, Long Term Care and Skilled Nursing Facilities, Ambulatory Surgical Centers, Hospitals, Community Mental Health Centers, and Outpatient Physical Therapy. The Supreme Court’s ruling did not change the requirements of the CMS IFR.  In essence, covered facilities must: Implement a process or plan to vaccinate all eligible staff by the compliance deadline (which is different for the injunction and non-injunction states). The CMS IFR is not a “vaccinate-or-test” mandate like the OSHA ETS.  Rather, under the IFR, vaccination is the only option unless staff qualify for a medical or religious exemption. Implement a process or plan to consider requests medical and religious exemptions. Implement a process or plan to track and document staff vaccines and exemptions so each facility can produce the documentation during a survey. Our prior blog post, available here, provides additional detail on the IFR’s requirements as well as practical recommendations for compliance and next steps. In response to the Supreme Court’s ruling, on January 14, 2022 CMS issued additional guidance, QSO-22-09-ALL for the IFR, applying to all but one of the injunction states (Texas was exempted from the new guidance due to ongoing separate challenges, and CMS instructed state surveyors in the guidance to not undertake any efforts to enforce the IFR at this time).  That new CMS guidance contains the same provider-specific instructions as the previous guidance, except that there are new compliance deadlines for the injunction states. Under QSO-22-07-ALL and QSO-22-09-ALL: Penalties for non-compliance in nursing homes, home health agencies, and hospice include civil monetary penalties, denial of payments, and as a final measure, termination of participation in Medicare and Medicaid programs. Penalties for non-compliance for hospitals and other acute and continuing care providers is termination of participation in Medicare and Medicaid programs. However, “CMS’s primary goal is to bring health care facilities into compliance.” Termination from the Medicare and Medicaid programs will generally only occur after CMS gives a facility an opportunity to come into compliance. Absent approved medical or religious exemptions, CMS will consider facilities non-compliant if facility staff (as defined by the IFR) vaccination rates are under 100%. To provide covered facilities an opportunity to reach that 100% vaccination rate, CMS has adopted a phase-in period: Facilities are considered compliant with CMS’s IFR if, 30 days after the applicable QSO: 1) the facility has policies and procedures developed to ensure all facility staff are vaccinated for COVID-19, and 2) 100% of staff have at least dose of a COVID-19 vaccine (unless exempted) or 80% of staff have at least one dose of a COVID-19 vaccine and the facility has a plan to achieve 100% vaccination within 60 days. For the non-injunction states, the 30-day deadline is January 27, 2022.  For the injunction states, the 30-day deadline is February 13, 2022. Facilities are considered non-compliant with CMS’s IFR if, 60 days after the applicable QSO, less than 100% of all non-exempted staff have at least one dose of a one-dose COVID-19 vaccine or two doses of a two-dose series. In that case, the facility will receive a notice of non-compliance, except that facilities with a vaccination rate (less exemptions) above 90% with a plan to reach 100% (less exemptions) within 30 days will not be subject to additional enforcement action.  For the non-injunction states, the 60-day deadline is February 28, 2022.  For the injunction states, the 60-day deadline is March 15, 2022. Facilities are considered non-compliant with CMS’s IFR if, 90 days after the applicable QSO (and anytime thereafter), less than 100% of all non-exempted staff have received at least one dose of a one-dose COVID-19 vaccine or two doses of a two-dose series.  These facilities may be subject to enforcement action.  For the non-injunction states, the 90-day deadline is March 28, 2022.  For the injunction states, the 90-day deadline is April 14, 2022. It is important to note that the Supreme Court did not rule on the merits (legality) of the CMS IFR.  Last week’s ruling is limited to whether the CMS IFR should be enjoined prior to a ruling on the merits.  The merits question is still yet to be resolved and when federal courts make those decisions, they will almost certainly make their way back to the Supreme Court for a final decision.  Given the language and reasoning of the Supreme Court’s injunction decision, it appears there is a high likelihood that a majority of Supreme Court justices would uphold CMS’s vaccine mandate on the merits. The bottom line is that the CMS IFR is now in effect throughout the country, except in Texas, and despite CMS’s message that it will provide entities with some leeway as described above, covered entities should immediately take steps to become compliant.  Dorsey’s health care and labor & employment attorneys are available to assist any health care provider with questions about implementation of CMS’ vaccine mandate.

On November 29, 2021, a federal court in Missouri enjoined the Centers for Medicare and Medicaid Services’ (CMS) vaccine mandate in the following states: Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.  Those ten states filed a lawsuit on November 10, 2021, challenging the vaccine mandate and requesting a preliminary injunction.  The new CMS vaccine mandate which we wrote about here requires covered staff to receive their first COVID-19 vaccine dose by December 5, 2021 and be fully vaccinated by January 4, 2022.  In granting the preliminary injunction, the district court specifically ordered: Defendants are preliminarily enjoined from the implementation and enforcement of 86 Fed. Reg. 61,555 (Nov. 5, 2021), the Interim Final Rule with Comment Period entitled “Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination,” against any and all Medicare- and Medicaid-certified providers and suppliers within the States of Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming pending a trial on the merits of this action or until further order of this Court. Defendants shall immediately cease all implementation or enforcement of the Interim Final Rule with Comment Period as to any Medicare- and Medicaid certified providers and suppliers within the States of Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming. What this means is that as of November 29, 2021, the December 5, 2021, and January 4, 2022 deadlines are on hold for employers covered by the CMS mandate in Alaska, Arkansas, Iowa, Kansas, Missouri, Nebraska, New Hampshire, North Dakota, South Dakota, and Wyoming.  Any vaccine mandates enforced by covered employers in those states will be considered voluntary and subject to any state laws regarding vaccine mandates.  Of the ten states, only Arkansas, Iowa, and Kansas have laws regulating COVID-19 vaccine mandates for private employers: Arkansas – On October 13, 2021, Arkansas’ Governor allowed several vaccine-related bills to become law without his signature. The bills require employers to allow employees to obtain a waiver from a COVID-19 vaccine mandate if the employee produces a negative COVID-19 test once a week or provides proof of COVID-19 antibodies once every six months. Iowa – On October 29, 2021, Iowa’s Governor signed a law requiring employers to grant exemptions from vaccine mandates beyond those required by federal law. Specifically, in addition to waivers for sincerely held religious beliefs, Iowa employers that voluntarily implement vaccine mandates must grant a waiver if an employee submits a statement that receiving the vaccine would be injurious to the health and well-being of the employee or an individual residing with the employee.  In addition, Iowa employees discharged for not complying with an employer’s vaccine mandate are eligible for unemployment benefits under the new law. Kansas – On November 22, 2021, the Governor of Kansas signed a law with medical waiver requirements similar to Iowa’s law. On religious waivers, Kansas’ law goes beyond what is required by federal law, mandating that employers grant requests for religious exemptions “without inquiring into the sincerity of the request.” The law also outlines a complaint and investigation procedure for alleged violations and provides for monetary penalties that increase depending on the size of the employer. In addition, like the Iowa law, Kansas employees discharged for not complying with an employer’s vaccine mandate are eligible for unemployment benefits. The Biden Administration will almost certainly appeal the preliminary injunction.  The Eighth Circuit Court of Appeals would consider the appeal and could overturn the injunction and reinstate the mandate.  Given the timeline, we expect that new compliance deadlines would be established in the event the preliminary injunction is overturned. What should employers do? Covered employers in the ten states at issue who do not wish to proceed with a voluntary vaccine mandate may pause their current efforts to comply with the CMS vaccine mandate, but should at a minimum proceed with preparing a policy, religious and medical exemption forms, and an exemption review process so that employers are ready to proceed within any established deadlines if the preliminary injunction is lifted and the mandate is reinstated.  This is the same recommendation we have given to large employers covered by the Occupational Safety and Health Administration’s COVID-19 Vaccination and Testing Emergency Temporary Standard (OSHA ETS), which was stayed by the Fifth Circuit Court of Appeals on November 12, 2021.[1] Employers looking for consistency when it comes to COVID-19 vaccine mandates will not find it in today’s ruling and healthcare employers can once again add themselves to the list of employers who operate in multiple states and must undertake the task of wading through the various federal mandates and their legal statuses.  It is both possible and probable that multi-state healthcare employers will be required to comply with CMS’s federal vaccine mandate in one state while operating in another state wherein, at least for now, CMS’s federal vaccine mandate no longer exists. Dorsey’s employment and health care attorneys will continue to monitor the developments in this matter and will update our blog with changes.   [1] On November 23, 2021, the Biden Administration asked the Sixth Circuit Court of Appeals to reinstate the OSHA ETS vaccine mandate, following a lottery that assigned to that Circuit multiple challenges to the vaccine mandate.

**Note that a federal court has issued a temporary injunction stopping the CMS COVID-19 vaccine mandate in certain states.  Please read our blog post here for the latest information on this injunction. Last week, the Centers for Medicare and Medicaid Services (CMS) and the Occupational Safety and Health Administration (OSHA) published their much-anticipated rules mandating COVID-19 vaccinations.  This article focuses on the new CMS rules, and you can read about Dorsey’s analysis of the new OHSA Emergency Temporary Standard (ETS) here. Please note that if the CMS COVID-19 vaccine mandate applies to your facility, you must comply with the CMS COVID-19 vaccine mandate instead of with the new OSHA ETS. However, the above link to our article on the new OSHA ETS provides useful guidance on topics which apply generally to employers such as how to handle vaccine exemption requests. On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued its interim final rule (IFR) with comment period regarding staff vaccination requirements as a condition of receipt of Medicare or Medicaid funds.  CMS estimates that there will be more than 180 million staff, patients, and residents employed or treated at facilities covered by the rule, making the impact colossal.  The IFR is an emergency regulation, meaning that it takes effect on the date it is published in the federal register, November 5, 2021, and prior to the comment period.  Stakeholders will have 60 days, until January 4, 2022, to submit formal comments.  At that point, CMS will consider the comments in any future rulemaking it undertakes.  CMS also issued a press release and published FAQs to assist health care facilities in the understanding of these new regulations. The IFR applies to the following Medicare/Medicaid certified providers and suppliers: Ambulatory Surgical Centers (ASCs) Hospices Psychiatric residential treatment facilities (PRTFs) Programs of All-Inclusive Care for the Elderly (PACE) Hospitals (acute care hospitals, psychiatric hospitals, hospital swing beds, long term Care hospitals, children’s hospitals, transplant centers, cancer hospitals, and rehabilitation hospitals/inpatient rehabilitation facilities) Long Term Care (LTC) Facilities, including Skilled Nursing Facilities (SNFs) and Nursing Facilities (NFs), generally referred to as nursing homes Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Home Health Agencies (HHAs) Comprehensive Outpatient Rehabilitation Facilities (CORFs) Critical Access Hospitals (CAHs) Clinics, rehabilitation agencies, and public health agencies as providers of outpatient physical therapy and speech-language pathology services Community Mental Health Centers (CMHCs) Home Infusion Therapy (HIT) suppliers Rural Health Clinics (RHCs)/Federally Qualified Health Centers (FQHCs) End-Stage Renal Disease (ESRD) Facilities[1] Indian Health Service (IHS) Facilities   A. What Must Covered Facilities Do? Under the IFR, the above-described “covered facilities” must develop, by December 5, 2021, a plan and procedure for requiring the COVID-19 vaccine for covered staff (as defined below),[2] collecting and storing vaccination data, considering medical and religious exemptions for covered staff, and contingency planning for unvaccinated staff.  Individuals are on a deadline to be fully vaccinated against COVID-19, with accommodations considered as required by law (discussed below). Unless exempted, staff must have their first dose of a two-dose COVID-19 vaccine or a one-dose COVID-19 vaccine by December 5, 2021. Staff must complete the vaccination series, and be “fully vaccinated”, by January 4, 2022. Fully vaccinated is defined as two or more weeks after the completion of a vaccination series; staff members will be considered compliant even if not fully vaccinated by January 4 as long as they have completed the vaccination series by then.[3]   A previous COVID-19 infection will not be considered a substitute for proof of vaccination.  Staff hired after December 5, 2021 must receive their first vaccine dose prior to providing any care, treatment, or other services. The IFR defines the term “staff” to include “facility employees; licensed practitioners; students, trainees, and volunteers; and individuals who provide care, treatment, or other services for the facility and/or its patients, under contract or other arrangement.”[4]  The fact that care may not be provided in a formal clinical setting does not relieve staff from the mandate.  How frequently a person physically enters a covered healthcare setting is also irrelevant. Only those staff who perform 100% of their work remotely (i.e. telehealth or payroll) are fully exempt from the vaccine mandate. This means that even staff who “occasionally encounter fellow staff, such as in an administrative office or at an off-site staff meeting, who will themselves enter a health care facility or site of care for their job responsibilities,” also must be vaccinated under the IFR. The IFR lists the following as acceptable proof of vaccination: CDC COVID-19 vaccination record card (or a legible photo of the card), documentation of vaccination from a health care provider or electronic health record, or a state immunization information system record.  Covered facilities must keep the proof of vaccination confidential, i.e. with a facilities immunization record, health information files, or other relevant confidential documents.    Facilities may choose how to collect and store this information. B. Exemptions from COVID-19 Vaccination Requirements and Conflicts with State Laws Title VII of the Civil Rights Act of 1964 (Title VII) and the Americans with Disabilities Act (ADA) allow for religious and medical exemptions, respectively, to the COVID-19 vaccine.  The IFR specifically directs healthcare entities to provide exemptions from the COVID-19 vaccine consistent with federal law, but medical exemptions appear narrow, including certain allergies and recognized medical conditions that make the COVID-19 vaccine contraindicated.  The IFR specifically directs facilities to the CDC’s Summary Document for Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Medical exemption request must be supported by documentation that is: Signed and dated by a licensed practitioner, who is not the individual requesting the exemption, and who is acting within their respective scope of practice as defined by, and in accordance with, all applicable State and local laws. Such documentation must contain all information specifying which of the authorized COVID-19 vaccines are clinically contraindicated for the staff member to receive and the recognized clinical reasons for the contraindications; and a statement by the authenticating practitioner recommending that the staff member be exempted from the facility’s COVID-19 vaccination requirements based on the recognized clinical contraindications. But, what happens when there are conflicts with state laws on exemptions?  New state laws signed by the governors of Texas and Iowa, for example, provide employees with exemptions beyond those required by these federal laws.  For example, employers in Texas must allow exemptions from the COVID-19 vaccine based on an employee’s “reason of personal conscience.”  This Texas law expands the application of religious exemptions beyond a “sincerely held religious belief, practice or observance” which is the standard for a waiver under Federal law.  In Iowa, employers must allow exemptions from the COVID-19 vaccine based on an employee’s statement that receiving the vaccine “would be injurious to the health and well-being of the employee or an individual residing with the employee.”  The Iowa law not only expands the medical exemption beyond the ADA, but also removes the requirement that a medical exemption be supported by a licensed practitioner. Anticipating such conflicts, the IFR explicitly states: We understand that some states and localities have established laws that would seem to prevent Medicare- and Medicaid-certified providers and suppliers from complying with the requirements of this IFC.  We intend, consistent with the Supremacy Clause of the United States Constitution, that this nationwide regulation preempts inconsistent State and local laws as applied to Medicare- and Medicaid-certified providers and suppliers. . . . As is relevant here, this IFC preempts the applicability of any State or local law providing for exemptions to the extent such law provides broader exemptions than provided for by Federal law and are inconsistent with this IFC. (Emphasis added) The FAQs issued by CMS underscore this position, stating that no exemptions should be granted if not legally required under the ADA or Title VII, nor should an exemption be granted to someone “who requests an exemption solely to evade vaccination.”[5] In response to the federal government’s simultaneous release of the equally long-awaited Emergency Temporary Standard (ETS) from OSHA, Iowa Governor Kim Reynolds announced plans to challenge the ETS in court.  She made no similar plans regarding the IFR.  In addition, Arkansas, Alaska, Missouri, Iowa, Montana, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming joined in a federal lawsuit filed last week in Missouri challenging the government’s vaccination requirements for federal contractors and subcontractors.  The OSHA ETS was promptly stayed in court, and as of the publication of this article, we are awaiting a decision about whether the ETS will be permitted to proceed. Healthcare employers are encouraged by CMS to follow the guidance released by the Equal Employment Opportunity Commission (EEOC) related to medical and religious exemptions for employees.  Employers should develop a process for fairly reviewing medical and religious exemptions on an individualized basis that shows thoughtful consideration and analysis of each request.  If employers grant exemptions, they must take steps to minimize the risk of COVID-19 transmission.  Such steps could include additional or enhanced personal protective gear, separation barriers, elimination or substitution of less critical job duties, temporary modification of work schedules, or moving the location of where one performs work. C. How the Federal Rules Interact: Conflicts Between Federal Laws In addition to potential conflicts between state laws and the federal rules, healthcare facilities may also have questions about which of the federal rules reign supreme.  The IFR’s FAQs address this as well: If a Medicare- or Medicaid-certified provider or supplier falls under the requirements of CMS’s IFR, the IFR must be followed. 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 (CoPs), Conditions for Coverage (CfCs), and Requirements for Participation (RoPs), then they, too, are expected to abide by the requirements established in CMS’s IFR. Importantly, the IFR takes priority over other federal vaccination requirements (i.e. the Executive Order for federal contractors and subcontractors, and the OSHA ETS for employers with 100+ employees). The Executive Order for federal contractors and subcontractors may apply to staff who are not subject to the vaccination requirements outlined in the IFR. If a facility is subject to both the Executive Order and the new OSHA ETS for large employers, the facility should follow the Executive Order for federal contractors and subcontractors. The OSHA ETS for employers with 100+ employees applies to employers that are not subject to the CMS IFR or the Federal Contractor and Subcontractor Executive Order. Additionally, employers subject to the OSHA COVID-19 Healthcare ETS need not also comply with the new OSHA ETS for large employers. The bottom line is that the federal government does not intend for an employer or covered facility to assure compliance with more than one federal rule.  If there is some question about with rule applies to a particular entity, entities should comply with the strictest federal rule applicable to the entity. Vaccine mandate laws, interpretations and challenges are rapidly developing across the U.S.  If you have any questions about vaccine mandates, please contact your regular Dorsey attorney or any of the authors of this article. [1] The IFR does not apply to other healthcare entities not regulated by CMS (i.e. physician offices, Assisted Living Facilities, Group Homes, home and community-based services, or schools), but those entities could be subject to other federal vaccine requirements.  In addition, Religious Nonmedical Health Care Institutions (RNHCIs), Organ Procurement Organizations (OPOs), and Portable X-Ray Suppliers are not covered by the IFR even though those entities are regulated by CMS.  However, it is important to note that staff of these entities may be indirectly included in CMS’ vaccine requirements through their service arrangements with hospitals, long term care facilities, and other providers and suppliers who are covered under the IFR.  Further, it is possible that staff may be required by other federal or state laws to obtain a COVID-19 vaccination. [2] Covered individuals will be referred to throughout this post as “staff,” because coverage of the rule extends beyond those individuals who are employed by covered facilities, but also includes medical staff, contractors and volunteers, as discussed herein. [3] The IFR references booster vaccines but does not require them. [4] CMS considered limiting vaccine requirements to full-time employees.  Ultimately, CMS concluded that including a broader group of those required to be vaccinated would be manageable without creating major issues for compliance, enforcement, and record-keeping. [5] The FAQs also add that the IFR preempts any contrary state laws pursuant to the Supremacy Clause of the United States Constitution.  

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Katie Ervin Carlson and Aaron Goldstein for the following e-newsletter update: On October 25, 2021, the Equal Employment Opportunity Commission (“EEOC”) released additional guidance for employers navigating their way through employee requests for religious exemptions from COVID-19 vaccine mandates.  The update supplements guidance initially released by the EEOC in May, and attempts to address some of the situations employers have faced as workplace COVID-19 vaccine mandates grow in popularity and as the Occupational Safety and Health Administration (”OSHA”) and the Centers for Medicare & Medicaid Services (“CMS”) prepare to issue federal mandates in addition to those already in place for federal contractors. You can read the rest of the article, by clicking here.

On May 28, 2021, a group of Houston Methodist Hospital employees filed a lawsuit challenging the hospital’s COVID-19 vaccine mandate for employees.  The lawsuit, filed by 117 employees, was the first to challenge a health care employer’s COVID-19 vaccine mandate.  The employees’ grievances included that the vaccine is unsafe and that employers may not treat an employee like “a human guinea pig.”  At that time, all three COVID-19 vaccines were still being administered under the Food and Drug Administration “FDA”)’s Emergency Use Authorization (“EUA”). On June 12, 2021, a federal district judge dismissed the lawsuit.  The judge cited several reasons in dismissing the suit, including the Equal Employment Opportunity Commission (“EEOC”)’s guidance that, with medical and religious exemptions, employers can require employees to get the COVID-19 vaccine.  In response to the claim that the hospital was violating employees’ human rights by requiring the COVID-19 vaccine, the judge stated: The hospital’s employees are not participants in a human trial.  They are licensed doctors, nurses, medical technicians, and staff members.  The hospital has not applied to test the COVID-19 vaccines on its employees, it has not been approved by an institutional review board, and it has not been certified to proceed with clinical trials. As to the employees’ argument that they were being coerced into getting the vaccine or risk termination, the judge held: If a worker refuses an assignment, changed office, earlier start time, or other directive, he may be properly fired.  Every employment includes limits on the worker’s behavior in exchange for his remuneration.  That is all part of the bargain. The idea that employers routinely set workplace rules by which employees can either choose to abide or find other employment was central to a recent decision by a court in the Eastern District of Kentucky on September 24, 2021.  That case, Beckerich, et. al. v. St. Elizabeth Medical Center, et. al., was filed on September 3, 2021, by 40 hospital employees challenging the hospital system’s COVID-19 vaccine mandate.  The employees argued several violations, including that the mandate constituted fraud on behalf of the hospital, the United States Government, the Biden Administration, and the media.  One difference between the Houston Methodist and the St. Elizabeth case is that on August 23, 2021, the FDA gave full approval to the Pfizer-BioNTech COVID-19 Vaccine.  That full approval likely ended the likelihood that any employees going forward will be able to seriously argue that requiring the vaccine was tantamount to human experimentation. In denying the employees’ request for a temporary injunction (which would have halted the hospital’s mandate from going forward until the case could be fully decided on the merits), the court rejected the employees’ attempt to make constitutional claims on the basis that the hospital, by receiving federal funds, is essentially a governmental actor.  To that argument the court stated, “[p]rivate hospitals, no matter how much federal funding they may receive, are generally not state actors for purposes of constitutional questions.” The court also examined how the “greater good” should be analyzed in the context of legal challenges to COVID-19 vaccine mandates, asking, “[i]s the ‘greater good’ made up of many different individual liberties, is it a singular collective liberty, or is it both?”  The court then looked to a United States Supreme Court case from 1905 upholding Massachusetts’ small pox vaccine mandate.  We previously discussed that case in an update outlining President Biden’s COVID-19 Action Plan. Like the court in Houston Methodist, the judge in St. Elizabeth noted that employers make rules all the time, and employees have a choice whether to follow those rules or find work elsewhere: “To work at St. Elizabeth, Plaintiffs agree to wear a certain uniform, to arrive at work at a certain time, to leave work at a certain time, to park their vehicle in a certain spot, to sit at a certain desk and to work on certain tasks.  They also agree to receive an influenza vaccine, which Defendants have required of their employees for the past five years. These are all conditions of employment, and ‘“every employment includes limits on the worker’s behavior in exchange for his remuneration.’ . . . If an employee believes his or her individual liberties are more important than legally permissible conditions on his or her employment, that employee can and should choose to exercise another individual liberty, no less significant – the right to seek other employment.” While these cases involve challenges to voluntary COVID-19 vaccine mandates, the legal reasoning utilized by the courts might prove to be a roadmap for challenges to the vaccine mandates that are part of President Biden’s COVID-19 Action Plan.  That includes an expansion of a previously announced but not yet released requirement that health care employers (previously just long term care providers) require the COVID-19 vaccination as a condition of receipt of Medicare and Medicaid funds.

On September 9, 2021, the Biden Administration announced its new COVID-19 Action Plan (the “Action Plan”), which outlines a six-pronged approach to combat the pandemic.  The wide-ranging Action Plan lays out plans to vaccinate the unvaccinated, further protect the vaccinated, keep schools safely open, increase testing and masking, protect the economic recovery, and improve care for those with COVID-19.  Three components of the Action Plan’s “vaccinate the unvaccinated” prong impose new requirements for employers.  Those components are: Require all employers with 100 or more employees to ensure their workers are vaccinated or tested weekly and to provide paid time off for employees to get vaccinated; Require COVID-19 vaccination for all federal workers and all employees of federal contractors and subcontractors; and Require COVID-19 vaccination for health care workers at Medicare and Medicaid participating hospitals and other health care settings. On the same day he issued the Action Plan, President Biden issued two executive orders requiring vaccination for all federal employees and directing the Safer Federal Workforce Task Force to issue COVID-19 safety-related guidance.  President Biden also instructed the Occupational Safety and Health Administration (“OSHA”) to issue an Emergency Temporary Standard (“ETS”) to implement the Action Plan’s employer obligations. A BRIEF HISTORY OF GOVERNMENT VACCINATION MANDATES, OSHA ETS AUTHORITY, AND EXISTING OSHA COVID-19 RULES In 1905, the United States Supreme Court upheld Massachusetts’s compulsory small pox vaccination law in a case challenging the constitutionality of the state’s vaccination mandate.  The decision did not address the constitutionality of a federal vaccination mandate or, if permissible, whether such a mandate may be issued by President without legislative action.  The decision did, however, provide analysis of the government’s ability to enact laws intending to protect the health and welfare of citizens during an outbreak or pandemic that will likely be relied on in any upcoming challenges to the Action Plan.  In response to claims that notions of liberty preclude government vaccine mandates, the Court stated: The liberty secured by the Constitution of the United States does not import an absolute right in each person to be at all times, and in all circumstances, wholly freed from restraint, nor is it an element in such liberty that one person, or a minority of persons residing in any community and enjoying the benefits of its local government, should have power to dominate the majority when supported in their action by the authority of the State. OSHA has authority to issue an ETS when “employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards” and when such emergency standard is “necessary to protect employees from such danger.”  OSHA’s ETS authority allows it to forego its normal what rulemaking process.  An ETS can remain in place for up to six months, at which time OSHA must replace it with a permanent standard adopted through the normal rule making process.  The last ETS OSHA issued before its June 2021 ETS for the prevention of COVID-19 in healthcare employment was a 1983 rule addressing workplace asbestos exposure that the Fifth Circuit Court of Appeals (covering Louisiana, Mississippi, and Texas) struck down months later in part on the grounds that OSHA did not provide sufficient support for its claim that 80 workers would die from asbestos exposure in the 6 months the ETS would cover. On June 10, 2021, OSHA issued the first nationwide workplace-safety rule in an ETS for health care employers in response to the COVID-19 pandemic, and it was codified in the Federal Register on June 21, 2021.  The motivation behind OSHA’s June 2021 ETS addressing COVID-19 protections for health care workers was OSHA’s determination that a “grave danger” to employee health existed related to the virus.   OSHA’s August update states “OSHA has determined that CDC’s guidance on health care settings has not changed and that the requirements of the health care ETS released on June 10, 2021, remain necessary to address the grave danger of COVID-19 in health care.”  OHSA indicates it will monitor and assess monthly the need for any updates or changes to the health care ETS. The Biden Action Plan in many ways follows OSHA’s August 13, 2021 advisory guidance aimed at mitigating and preventing the spread of COVID-19 in the workplace, but also imposes new legal obligations regarding COVID safety in the workplace. WHAT DOES THE BIDEN ACTION PLAN REQUIRE? A.   Employers with 100+ Employees. Vaccination or Weekly Testing Requirement OSHA is developing a rule that will require all employers with 100 or more employees to ensure their workforce is fully vaccinated or require any workers who remain unvaccinated to produce a negative test result on at least a weekly basis before coming to work.  OSHA will issue an ETS to implement the requirement.  This requirement is expected to affect over 80 million workers in private sector businesses with 100 or more employees. Several questions remain regarding exactly how OSHA will implement the COVID-19 Action Plan for private employers, including how OSHA will determine whether an employer has more 100 or more employees for purposes of the ETS, who will pay for the weekly testing, the deadline for meeting the ETS standards, and how OSHA will apply penalties for non-compliance.  While there is little doubt that the ETS will contain exceptions for employees who are unable to be vaccinated due to a disability or sincerely held religious belief, as is protected under federal and state laws, it will remain to be seen whether states which have enacted laws prohibiting employers from mandating vaccinations for employees will bring legal challenges to the ETS and the Action Plan more broadly. It is widely anticipated they will. Paid Leave for Vaccination. OSHA’s ETS will also require employers with more than 100 employees to provide paid time off for vaccination and, if needed, post-vaccination recovery.[1] B.   The Federal Government, Federal Contractors, and Federal Subcontractors. President Biden issued an Executive Order requiring all federal agencies to require COVID-19 vaccination for all of their employees, with exceptions only as required by law (e.g. religious and medical reasons).  The Order directs The Safer Federal Workforce Task Force to issue compliance guidance by September 16, 2021. The President signed a second Executive Order that applies to organizations that contract with the federal government and subcontractors to those contracts.  While the Executive Order itself does not contain a vaccine mandate, President Biden’s Plan indicates that the requirement that all federal employees receive the COVID-19 vaccine will “be extended to employees of contractors that do business with the federal government.” As to the contracts themselves, the Executive Order applies to any: (1) new contract, (2) new contract-like instrument, (3) new solicitation for a contract or contract-like instrument, (4) extension or renewal of an existing contract or contract-like instrument, or (5) exercise of an option on an existing contract or contract-like instrument.  The Executive Order covers these contracts or contract-like instruments that are for services, construction, or a leasehold interest in real property; for services covered by the Service Contract Act; for concessions; or in connection with federal property or lands and related to offering services for Federal employees, their dependents, or the general public. The Executive Order requires agencies to take steps to include by October 8, 2021 required language for all contracts and contract-like instruments entered into or otherwise meeting the criteria above on or after October 15, 2021. Extensions and options are used by the federal government pursuant to the Federal Acquisition Regulation, which permits solicitations and contracts to include an option clause that allows the government “to require continued performance of any services within the limits and at the rates specified in the contract.”  An option provision can be exercised more than once, but the total time of extension cannot exceed six months. The Executive Order governing federal contractors and subcontractors does not apply to: (1) grants, (2) contracts, contract-like instruments, or agreements with Indian Tribes under Public Law 96-638, (3) contract or contract-like instruments with value equal to or less than the simplified acquisition threshold as defined by the Federal Acquisition Regulation, (4) employees who perform work outside of the United States, or (5) subcontracts solely for the provision of products. In defining “contract-like instruments,” the Executive Order refers to the Department of Labor’s proposed rule, “Increasing the Minimum Wage for Federal Contractors,” 86 Fed. Reg. 38816, 38887 (July 22, 2021). The Executive Order requires executive departments and agencies to ensure that contracts and contract-like instruments include a clause that contractors and subcontractors must incorporate into lower-tier subcontracts.  The clause will mandate compliance with “all guidance for contractor or subcontractor workplace locations published by the Safer Federal Workforce Task Force” and will apply to any locations in which an individual works in connection with a federal contract or contract-like instrument.  The Task Force is to issue such guidance no later than September 24, 2021.  Thus, the Executive Order does not require contractors and subcontractors to create vaccination mandate language.  Rather, their responsibility will be to include required language in contracts and develop workplace plans that ensure compliance it. For contracts not covered by the Executive Order, the President has “strongly encouraged” contractors and subcontractors to follow any safety protocols developed by the Safer Federal Workforce Task Force. C.  Medicare and Medicaid Participating Hospitals and Other Health Care Settings. Prior to the Action Plan’s launch, organizations that advocate for long-term-care facilities urged the Administration to mandate the COVID-19 vaccine throughout the health care industry, citing concerns over existing staffing shortages that facilities feared would worsen if long-term-care workers who wished to decline the vaccine had the option to work in other health care facilities.  In response, on August 18, 2021, President Biden announced plans to require long-term-care facilities to have “fully vaccinated” workforces as a condition of receiving Medicare or Medicaid funding.  Details of those requirements are yet to be released, but in the Action Plan, he expanded that mandate to all healthcare workers at Medicare and Medicaid-participating healthcare organizations, including, but not limited to, hospitals, dialysis facilities, ambulatory surgical settings, and home-health agencies. While OSHA’s June 2021 ETS was broadly aimed at protecting health care workers amid the COVID-19 pandemic, it stopped short of requiring vaccines. President Biden’s COVID-19 Action Plan goes further by requiring vaccinations for many employees in the healthcare industry. D.   All Employers For months, the Equal Employment Opportunity Commission (“EEOC”) has opined that all employers under its jurisdiction may elect to mandate COVID-19 vaccination for their employees. As we have previously discussed, employers that mandate the vaccine must make exceptions for medical and religious reasons or risk violating state and federal anti-discrimination laws. Small employers who hope to avoid vaccine mandates may also incentivize employee vaccination.  The EEOC’s guidance explains that employers that administer vaccines may incentivize vaccination, as long as the incentives are non-coercive. PRACTICAL STEPS FOR EMPLOYERS Employers with 100 or more employees should begin considering and developing a vaccination policy that will comply with the Action Plan. All employers mandating vaccines should consider the potential for exemptions for reasonable accommodations for religious belief and disabilities, pursuant to Title VII of the Civil Rights Act of 1964 (“Title VII”) and the Americans with Disabilities Act (“ADA”), as well as applicable state law. Employers should confirm whether they are a federal contractor or subcontractor. Federal contractor status is present if an organization has a contract with the federal government.  Federal subcontractor status can be determined through a letter from a government contractor stating your organization is a subcontractor necessary for the performance of a government contract or undertaking a federal contractor’s obligation under its contract. Other ways to assess federal-contractor/subcontractor status include a search on the Federal Procurement Data System or USA spending either by searching for the organization name or Dun & Bradstreet number. Employers with under 100 employees, and those without existing federal contracts not subject to the Executive Order, should consider whether to adopt vaccine mandates or incentives as outlined by the EEOC. Employers should anticipate changes to new requirements due to COVID-19 itself (Delta, Mu, and other variants) and how to respond to such changes. [1] President Biden’s COVID-19 Action Plan states that private employers with “100 or more” employees must require vaccination, but that private employers with “more than 100” employees must provide paid vaccination leave.  While this may be an unintentional typo, we recommend employers presume that if they are required to mandate the vaccine, they are also required to provide paid vaccination leave.

As we have previously written, the landscape for employers in the time of COVID-19, particularly health care employers and long term care facilities, is ever-changing and quickly moving.  In the last year, health care employers have had to navigate state laws, Centers for Disease Control and Prevention (“CDC”) and Centers for Medicare & Medicaid Services (“CMS”) guidance, EEOC guidelines, as well as compliance with a complex Emergency Temporary Standard (“ETS”) issued by the Occupational Safety and Health Administration (“OSHA”). In the midst of all that, health care providers have grappled with whether to implement policies requiring COVID-19 vaccinations for employees absent a religious or medical exemption.  In Iowa, Unity Point Health, Sanford Health, MercyOne, Genesis Health System, and Trinity Health will require employees to be vaccinated for COVID-19 in the next few weeks and months.  This includes long term care facilities administered by those entities. In a somewhat unexpected twist, the Biden Administration announced today that CMS and the CDC are “developing an emergency regulation requiring staff vaccinations within the nation’s more than 15,000 Medicare and Medicaid-participating nursing homes.”  According to the announcement, a rule is expected in the coming weeks.   The Administration’s order will surely generate multiple lawsuits challenging the legality of the mandate.  We estimate that those lawsuits will likely not be successful, in part based how quickly similar lawsuits against hospital employers have been dismissed by courts across the country.  For example, this summer a court swiftly dismissed a lawsuit filed by employees of Houston Methodist hospital challenging the hospital’s COVID-19 vaccine mandate. Last week, in addition to the OSHA ETS for healthcare employers published on June 21, 2021, OHSA issued new recommendations for all employers with a specific focus on protecting unvaccinated workers.  To combat the continued spread of COVID-19, OSHA recommends that employers do the following: Assist employees in getting vaccinated for COVID-19, including paid time off to get and recover from vaccines. Some employers can receive tax benefits for voluntarily paying employees under these and other circumstances. Remove employees with known or suspected COVID-19 exposure from the workplace for either 14 days or until the employee receives a negative test result. Make sure that unvaccinated and high risk employees physically distance from others, limit the number of unvaccinated and high risk employees at one place at any given time, allowing remote working for unvaccinated and high risk employees, and installing transparent barriers when physical distancing is not feasible. Require employees to wear masks indoors (unless other PPE is otherwise required for the job), and provide face coverings to employees who do not have their own. Educate employees on workplace COVID-19 policies and procedures, including providing materials in multiple languages as needed. Suggest that unvaccinated customers, vendors, visitors, or other guests wear a mask. Maintain properly working ventilation systems. Follow CDC guidelines regarding cleaning and disinfection. Record and report workplace infections and deaths related to COVID-19. Implement policies and procedures to ensure that employees who raise concerns about COVID-19 in the workplace are not subject to retaliation. Follow any other applicable mandatory OSHA standards. In sum, OSHA recommends that, for the most part, all employers follow the requirements set forth for healthcare providers in the ETS. We want to help all employers keep their employees safe and protected from COVID-19, and we want to help you do your part to prevent the spread of the virus.  If you have any questions about what you are required by law to do in your workplace, or what is not required but recommended, please contact a qualified employment and healthcare attorney.  

The COVID-19 pandemic required health care providers of all sizes to make drastic changes to the mode of patient care delivery. Telehealth quickly emerged as a safe alternative to in-person patient visits, and many providers quickly transitioned to virtual services. The pandemic-initiated expansion of telehealth was rapid and significant, but the pandemic likely accelerated existing trends more than creating new ones. The increased availability of telehealth has offered patients greater access levels and types of care that would otherwise be difficult to obtain due to geography, limited appointment availability, or affordability. Despite the increased access to care and positive experiences with telehealth over the past year and a half, many regulatory actions temporarily enabling the use of telehealth services have expired or will end in the coming months. What does the post-COVID future hold for tele health? Health care industry leaders are tracking the following developments: Licensing State professional licensure laws are major obstacles for telehealth providers wanting to offer telehealth services as an option for patients who reside or are otherwise located in other states. State laws governing the practice of medicine, nursing, social work, and other health professions generally require the provider furnishing care to be licensed in the state where the patient is located. At the beginning of the pandemic, the spike in demand for virtual care led states to quickly take action to loosen or waive professional licensure requirements. Many states allowed out-of-state health care providers of all types to provide telehealth services to their residents, including Hawaii, Idaho, and Vermont. States such as Illinois and Maryland permitted telehealth practice only where a provider had a pre-existing relationship with the patient, and others only relaxed requirements for physicians or mental health providers, such as in Minnesota. Post-pandemic, we expect to see continued efforts to remove licensing barriers faced by telehealth providers. Several states have enacted the Interstate Medical Licensure Compact or have entered into cross-border licensure waiver agreements with neighboring states, but these waiver agreements may only apply to certain practitioners or involve slow, costly application processes. Some states may follow the approach taken in Florida and Georgia, where health care providers can obtain a “telemedicine license” with less burdensome requirements. Action on the federal level is also possible. In response to COVID-19, the Centers for Medicare & Medicaid Services (“CMS”) temporarily waived the Medicare requirement that providers be licensed in the state they are delivering telemedicine services when practicing across state lines, subject to certain conditions. While this waiver does not exempt providers from licensure requirements under state law, subsequent action taken at the federal level may set a trend followed by state governments. Providers should also be aware of existing state laws permitting the practice of telehealth across state lines when an existing patient is on vacation or attending college in another state. For example, in Minnesota, out-of-state physicians are exempt from licensure requirements if only providing telehealth services on an “irregular or infrequent basis” as defined in Minn. Stat. § 147.032. And Colorado allows non-Colorado-licensed health care providers to provide occasional services or consultation via telehealth to patients in Colorado as long as they meet certain requirements, such as maintaining certain levels of insurance, not maintaining an office in the state, and not informally or formally agreeing to provide care on a regular or routine basis. See Colo. Rev. Stat. § 12-240-107. Reimbursement Before the pandemic, reimbursement options for telehealth were limited and low payment rates were a significant financial burden for providers seeking to provide telehealth services. As we described in a previous blog post, CMS implemented sweeping changes to Medicare reimbursement and coverage requirements at the start of the COVID-19 outbreak. Dozens of new services were added to the list of telehealth services covered by Medicare, restrictions on geography and originating sites were removed, and payment rates for telehealth services were raised to match the rates for the same in-person service. On July 13, CMS released its annual proposed rule for payments under the Medicare Physician Fee Schedule, which would make many temporary Medicare flexibilities for mental and behavioral health services permanent. If finalized, the rule would allow beneficiaries to receive such telehealth services from home, reimburse providers for audio-only services, and keep certain recently added services on the Medicare telehealth list through December 31, 2023. The rule would require an in-person visit within six months prior to an initial telehealth service and at least once every six months thereafter, but CMS is seeking input on whether a different interval may be necessary or appropriate. The agency is also soliciting comment on: Whether additional documentation should be required in the patient’s medical record to support the clinical appropriateness of audio-only telehealth; Whether or not audio-only telehealth for particular high-level services should be covered; and What additional guardrails should be put in place in order to minimize concerns about program integrity and patient safety. Several states have passed or proposed payment parity legislation that would permanently require insurance coverage and/or reimbursement for certain telehealth services at a level equal to in-person visits. For example, legislation was recently enacted in Oklahoma requiring payment parity for all telemedicine services. In states like Georgia and California, laws require equal coverage for both virtual and in-person services, but allow payers and providers to negotiate alternate payment rates. A recent Connecticut law requires payment parity for telehealth services under its state Medicaid program, and a Massachusetts law mandates payment parity for behavioral health services. Privacy In response to the pandemic, the Office for Civil Rights (“OCR”) announced several telehealth flexibilities to allow providers to care for patients remotely during the pandemic. OCR announced it would not impose penalties on providers for noncompliance with certain HIPAA obligations in connection with their “good faith provision of telehealth” using any non-public communication platform, such as FaceTime or Zoom. Given increasing concerns about cybersecurity and privacy risks, we expect continued discussions at the federal and state level about how to safeguard patient’s health information while allowing continued access to telehealth services. Providers should conduct a comprehensive risk assessment of its privacy and security protections and vendor agreements to ensure all telehealth technologies and IT systems comply with HIPAA standards. Conclusion The COVID-19 pandemic has profoundly changed the health care delivery landscape. As emergency orders end and regulatory flexibilities expire, policymakers at the state and national level are considering how best to regulate telehealth post-pandemic. Telehealth services ease the burden of obtaining quality healthcare services for medically underserved populations, including communities of color, people with disabilities, and residents of rural areas.  Telehealth also gives patients the opportunity to conveniently obtain routine and preventative care, which could positively impact health outcomes and improve health equity. Dorsey attorneys are closely monitoring federal and state actions regarding telehealth. For more information on how to navigate the existing legal landscape and prepare for future developments, contact the authors or your regular Dorsey attorney.

On June 10, 2021, Dorsey’s Labor & Employment attorneys outlined an Emergency Temporary Standard (“ETS”) issued by OSHA.  At the time, the ETS was not an official regulation because it had not yet been published in the Federal Register.  On June 21, 2021, the ETS was published and, for covered healthcare employers, the compliance clock started ticking. As a refresher, the ETS applies to “all settings where any employee provides healthcare services or healthcare support services.”  1910.502(a)(1).  Broadly, the following activities are exempted from coverage: the provision of first aid by an employee who is not a licensed health care provider; the dispensing of prescriptions by pharmacists in retail settings; non-hospital ambulatory care settings where all non-employees are screened prior to entry and people with suspected or confirmed COVID–19 are not permitted to enter those settings; well-defined hospital ambulatory care settings where all employees are fully vaccinated and all non-employees are screened prior to entry and people with suspected or confirmed COVID–19 are not permitted to enter those settings; home health care settings where all employees are fully vaccinated and all non-employees are screened prior to entry and people with suspected or confirmed COVID–19 are not present; health care support services not performed in a health care setting (e.g., off-site laundry, off-site medical billing); or telehealth services performed outside of a setting where direct patient care occurs. In addition, for covered employers, ETS requirements regarding masking, physical barriers, and physical distancing do not apply to fully vaccinated employees in well-defined areas where there is no reasonable expectation that any person with suspected or confirmed COVID–19 will be present.  1910.502(a)(2)(i)-1910.502(a)(4). As to employee vaccinations, the ETS specifically contemplates that there may be medical conditions, disabilities, or religious reasons employees cannot be vaccinated.   Employers are reminded in the ETS guidance that they should make exceptions where appropriate.  We discussed EEOC guidance regarding employee vaccinations in a previous blogpost. Except for requirements regarding physical barriers, ventilation, and training, employers must comply with the ETS mandates by July 6, 2021.  Employers must become compliant with the physical barrier, ventilation, and training requirements by July 21, 2021. When OSHA first issued the ETS, little direction was available directly from OSHA in terms of how employers could comply with the ETS’s many mandates.  Since publication of the ETS in the Federal Register, OHSA has fortified existing resources and added new ones.  Employers should visit OSHA's ETS website for Fact Sheets, FAQs, Notification Removal and Return to Work Flow Charts for both Employers and Employees, Employee Training Presentations, and more. Further, it is important to understand how the new OSHA regulations interact with already existing guidance on similar COVID-19 related topics for health care providers which have been published by other federal and state agencies, such as the Centers for Medicare and Medicaid Services and the Centers for Disease Control and Prevention.  In most cases, the various guidance and regulations do not conflict, but a careful review of all related laws and agency guidance is prudent, in order to fully understand the rules that apply in a given situation, especially when there is a conflict. A qualified employment lawyer can assist employers with matters such as developing their COVID-19 Plan, planning the Workplace Hazard assessment, and conducting training; all things which are required by the ETS.  Please contact the author of this blog post or your regular Dorsey & Whitney labor and employment attorney with further questions about how to come into compliance with the new OSHA guidance by the July 6 and July 21 deadlines.

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Rebecca Bernhard, Aaron Goldstein and Alyson Dieckman for the following e-newsletter update: OSHA Issues COVID-19 Workplace Safety Rule for Healthcare Employers On June 10, 2021, the Occupational Safety and Health Administration (“OSHA”) released the first nationwide workplace safety rule in response to the COVID-19 pandemic.  OSHA’s guidance is only binding on healthcare employers.  OSHA reported that it will issue supplemental voluntary guidance for other industries. (Read more here.)

One of the last pieces of legislation the Iowa legislature sent to Governor Kim Reynolds’ desk for guaranteed signature was a bill banning vaccine passports in Iowa.  House File 889 contains several prohibitions regarding inquiries into a person’s COVID-19 vaccine status.  For entities that contract with the state government or otherwise receive state funding, the law contains financial consequences for a violation (but is silent as to penalties for others).  While the law contains clear proscriptions, it also has notable explicit and implicit exclusions. Healthcare providers, and nursing home facilities specifically, have additional considerations under recently released CMS, CDC and OSHA guidance.  All employers have considerations under state and federal anti-discrimination laws and updated EEOC technical assistance. Iowa Law Iowa’s law prohibits the designation of COVID-19 vaccine status on state or political subdivision-issued identification cards.  That means there will be no COVID-19 notations on Iowa drivers’ licenses anytime soon.  The law also forbids businesses or governmental entities from requiring customers, patrons, clients, patients, or other persons invited onto the premises (“invitees”) to show proof of a COVID-19 vaccine. However, the law does not list employees in the category of people who are protected from having to show proof of a COVID-19 vaccine.  Therefore, under Iowa law, employers can legally require employees to show proof of a COVID-19 vaccine as a condition of employment. Further, the law explicitly excludes healthcare facilities from the definition of a business or a governmental entity.  Healthcare facilities include hospitals and other licensed inpatient centers, ambulatory surgical or treatment centers, skilled nursing centers and nursing facilities, residential treatment centers, diagnostic, laboratory and imaging centers, rehabilitation and other therapeutic health settings, and intermediate care facilities for people with mental illness or intellectual disabilities. CDC, CMS and OSHA Guidance On April 27, 2021, the Centers for Disease Control and Prevention (CDC) published updated health care infection prevention and control recommendations following the wide availability of COVID-19 vaccination, available here.  The CDC guidance includes updated COVID-19 testing recommendations, updated visitation guidance for health care facilities, and additional guidance for communal activities and dining in healthcare settings. Shortly thereafter, on May 11, 2021, CMS published updated guidance for long term care (LTC) facilities, called an interim final rule.  That rule, available here, focuses on COVID-19 vaccination education, consent, and refusal, as well as the procedures LTC facilities must follow in offering vaccinations to employees and residents.  It also includes recordkeeping requirements.  The guidance is silent regarding whether LTC facilities can require employee or resident vaccinations, instead simply stating, “[f]acilities should follow state law and facility policies with respect to staff refusal of vaccination.” In Iowa, that means long term care facilities could choose to require all staff and residents to be vaccinated. On June 10, 2021, OSHA published the first guidance for employers governing workplace safety rules related to COVID-19, which applies only to employment settings where employees provide healthcare services or healthcare support services in a healthcare setting.  The new OSHA rules are entitled, the “COVID-19 Healthcare Emergency Temporary Standard”, and they are available here.  FAQs regarding the new regulations were published by OSHA and are available here.  The scope of this article does not cover the new OSHA COVID-19 Healthcare Emergency Temporary Standard because Dorsey attorneys published a separate article on this new guidance including practical tips for its implementation, which is available here. EEOC Guidance Health care facilities adopting COVID-19 vaccination requirements should be mindful of state and federal anti-discrimination laws such as the Iowa Civil Rights Act (ICRA) and the Americans with Disabilities Act (ADA).  Both the ICRA and the ADA prohibit employers and places of public accommodation from discriminating against people on the basis of their religion or disability, among other things.  Public accommodations include, but are not limited to places that offer services, facilities, or goods for a fee or charge.  To name a few, a person’s health condition could prohibit them from getting a COVID-19 vaccine, a person’s religion might prohibit vaccinations, a person may be reluctant to get the vaccine while pregnant, and data has shown that minority communities disparately have lower vaccination rates.  Health care facilities mandating vaccines could run into legal issues if they are unwilling to make exceptions in certain circumstances. Additionally, on May 28, 2021, the EEOC updated its technical guidance regarding whether employers can provide COVID-19 vaccine incentives for employees in a technical assistance Q&A, available here.  The EEOC guidance echoes the considerations above, noting that employers must take care not to run afoul of state and federal employment laws when making decisions about vaccine requirements.  The guidance also states the vaccine incentives cannot be coercive, and that employers must keep vaccine information confidential. Practical Tips and Take Aways In light of the ever-changing status of employment and health laws and guidance related to COVID-19, healthcare facilities drafting or updating policies related to COVID-19 mitigation should consult with their employment and health care counsel to make sure the policies are consistent with Iowa’s vaccine passport law, state and federal employment laws and technical assistance, and any recent CDC and CMS publications. That said, the following tips may help to guide health care facilities’ development of employment-related COVID-19 policies and procedures: Healthcare employers, particularly LTC facilities, considering mandating the COVID-19 vaccine for employees should also think about the impact such a mandate might have on the available workforce. With data suggesting that only about half (or less) of Iowa’s LTC facility employees are fully vaccinated, employers might see crippling staff shortages if they start making the COVID-19 vaccination a condition of new or continued employment. Healthcare employers seeking to increase their workforce’s COVID-19 vaccination rates could come up with ways to fairly incentivize employees, consistent with the recent EEOC technical assistance. Regardless of the type of vaccine, if employers choose to require vaccinations as a condition of employment, they should remember to keep all vaccination information confidential pursuant to the ADA. If employers believe that a lack of convenient access is a contributing factor to low employee COVID-19 vaccine rates, employers could consider holding vaccine clinics consistent with the CMS guidance described and linked above. Employers who do choose to hold vaccine clinics or otherwise make the COVID-19 vaccine available to employees at work should be cognizant of their workforce and adjust accordingly. For example, employers should think about whether informational materials should be offered in languages other than English and whether some of the people administering vaccines should be bilingual. Healthcare employers which are covered under the new OSHA COVID-19 Healthcare Emergency Temporary Standard referenced above (generally, those with 10 or more employees) should ensure that the company’s written COVID-19 plan incorporates all of the elements required under the new COVID-19 Healthcare Emergency Temporary Standard, including providing reasonable time off and paid leave for vaccinations and vaccine side effects for employees. For more information on the new OSHA standards, see a separate post by our Dorsey colleagues, available here. Prior to taking any adverse action against an employee related to that person’s COVID-19 vaccination status, or any other conduct pertaining to COVID-19, employers should seek guidance from a knowledgeable employment law attorney. As described in an earlier blog post, COVID-19 related lawsuits against employers are on the rise (including in Iowa), and employers need to be proactive in ensuring their decisions are consistent with the ever-changing legal landscape on these issues.

Despite widespread vaccine availability and the corresponding optimism about returning to “normal,” the coronavirus pandemic continues to spawn hundreds of employment and health-related lawsuits.  Many of these lawsuits have been aimed at employers in the healthcare sector and relate to workplace safety, retaliation, and wrongful termination or wrongful denial of leave.  In fact, since our last update on this topic (available here), the healthcare sector has increased its relative share of coronavirus lawsuits compared to other industries.  In December 2020, approximately 20 percent of lawsuits alleging labor and employment violations related to coronavirus arose from the healthcare industry; today, that number is approximately 25 percent. The total number of coronavirus lawsuits has also increased dramatically.  At the end of 2020, 1,235 total lawsuits had been filed against employers related to the coronavirus.  Today, that number has more than doubled; there have been 2,560 lawsuits, including 200 class actions.  States with the most filings include California (666), New Jersey (293), Florida (198), New York (184) and Ohio (156). Whether brought in California, Iowa, or elsewhere, coronavirus lawsuits most commonly assert that employers violated federal and state mandates, guidelines, and regulations regarding employee safety.  One such federal mandate was the Families First Coronavirus Response Act (FFCRA), passed by Congress in March 2020 (and, with certain exceptions, expired in December 2020).  While operative, the FFCRA required employers with fewer than 500 workers to provide employees with a certain amount of compensated time off for various reasons linked to COVID-19, including if employees become ill.  Importantly, however, the FFCRA provided that certain employees—i.e., “health care providers and emergency responders”—may be excluded from entitlement to both emergency family leave and emergency paid sick leave.  In addition to FFCRA cases, employees have also filed lawsuits alleging that their employers violated the federal WARN Act (or similar state laws), which in certain circumstances requires that employers with 100 or more employees provide at least 60 days’ notice before conducting a mass layoff. Even though there are fewer lawsuits involving COVID-19 related issues in states like Iowa, the recently filed Iowa cases are representative of the types of cases occurring across the country.  In one case, an employee of a hospital asserts that she was terminated after she raised concerns about the lack of available personal protective equipment and about staff failing to wear masks correctly.  She also claims that she raised concerns about an social event where staff were attending without masks and without adhering to social distancing guidelines.  Another case involves claims by a food manufacturer’s nurse supervisor asserting her employer’s lack of preparedness for COVID-19 and her resulting firing after she raised safety concerns. Although other employment-related cases in Iowa have been filed against employers outside the health care industry, similar cases could be filed against those in the health care industry in the future.  These cases include allegations that employers denied leaves of absence for an individual with high risk conditions and failure to implement proper screening, social distancing and other protective measures, which in one case resulted in deaths from COVID-19.  On the flip side, Iowa has also seen recent litigation filed with an individual asserting a civil rights violation for requiring students to wear a mask to school. A recent development that may impact future coronavirus litigation is the updated federal guidance on mask mandates.  On May 13, 2021, the U.S. Centers for Disease Control and Prevention (“CDC”) revised its guidance to reflect that “fully vaccinated” individuals no longer need to wear masks, whether indoors or outdoors, except in limited circumstances.  And while there is a caveat for “local business and workplace guidance,” OSHA is advising employers to follow CDC guidelines for fully-vaccinated employees.  Accordingly, employers across the nation now face the practical challenge of maintaining a safe and compliant workplace in an increasingly open environment, while at the same time minimizing their risk for legal liability. While many states have enacted legislation that limits the liability of healthcare providers for actions or omissions during the pandemic, most of the legislation leaves openings for plaintiff’s lawyers to argue that their clients’ claims are not prohibited, especially with respect to employment-related claims.  For example, Iowa enacted the “COVID-19 Response and Back-to-Business Limited Liability Act”.  Under the Iowa Act, providers cannot be held civilly liable for various actions, which include, but are not limited to screening, assessing, diagnosing, caring for or treating individuals with COVID-19. The Act also provides protection for acts or omissions relating to non-COVID-19 patients, if those acts or omissions result from supporting the state’s response to COVID-19. This may include acts such as providing treatment outside the premises of a health care facility or using equipment and supplies outside their normal use.  As seen by the lawsuits described above, the Iowa Act does not prevent the filing of employment-related claims and notably, liability can still be established even in non-employment related contexts if the provider acted recklessly or engaged in willful misconduct. Navigating the highly dynamic landscape of federal, state, and local coronavirus rules and policies presents numerous challenges for employers.  But healthcare providers can still employ a number of proactive steps to reduce their potential exposure. Providers should understand their obligations under relevant federal and state law and provide employees protected leave as appropriate. When in doubt, we recommend that employers err on the side of granting the requested leave. Providers should revise company policies as necessary to incorporate the new regulations that apply to COVID-19 exposure and sick leave. To the extent feasible, providers should consider offering teleworking opportunities for eligible employees. Providers should implement a system for recording employees’ requests for leave and the reasons supporting those requests, i.e., an employee’s symptoms and the date for a test or doctor’s appointment. However, providers should not require employees to provide further documentation, such as certification that the employee sought a diagnosis or treatment from a healthcare provider. Providers should be mindful of the risks of taking personnel actions that could lead to discrimination or retaliation lawsuits by workers who requested or took applicable leave. As always, providers should properly document their termination decisions. Providers should carefully consider whether and how they will ask employees to provide proof of vaccination, and they must be aware of relevant legal considerations if making those inquires. Several jurisdictions have implemented laws banning employers from requiring so-called “vaccine passports” or other methods of requiring individuals to provide proof of vaccination to gain access, entry, or service. Providers may initially want to strongly encourage employees to get vaccinated—with the caveat that it may be mandatory in the future—and only require vaccination in the future if absolutely necessary.

Among its many impacts, the coronavirus pandemic has already spawned hundreds of employment and health-related lawsuits, with even more litigation likely as businesses continue to bring back workers and increase operations.  Many of these lawsuits have been aimed at employers in the healthcare sector and relate to workplace safety, retaliation, and wrongful termination or wrongful denial of leave.  In fact, over 20 percent of the lawsuits alleging labor and employment violations related to the coronavirus arise from the healthcare industry. A recent lawsuit filed by a fired nursing assistant serves as a good example of the types of claims health care providers may soon face.  On April 1, 2020, Za’Taya Ballard was hired as a nursing assistant by Highland Park Care Center, a nursing home located in Pittsburgh.  On May 16, Ballard learned she had “prolonged close contact” with a person who had the virus.  Ballard was not wearing personal protective equipment at the time of the exposure.  Thereafter, Ballard notified the nursing home of her exposure and was removed from the upcoming work schedule so she could self-isolate for 14 days.  However, Ballard alleges that two days later, she was fired for missing work. On October 20, Ballard filed suit against the nursing home in Pennsylvania state court.  The case is Ballard v. Highland Park Care Center LLC, Case No. GD-20-011291, in the Court of Common Pleas of Allegheny County, Pennsylvania.  In her Complaint, Ballard brings a single count for “wrongful discharge in violation of public policy.”  According to Ballard, guidelines promulgated by the Centers for Disease Control, the Pennsylvania Department of Health, and the Governor of Pennsylvania evidence a “clearly-defined public policy” “for individuals who had prolonged exposure to confirmed cases of COVID-19 without protective gear to isolate themselves in an effort to prevent the virus’s spread.”  By purportedly firing her due to her request to quarantine, Ballard alleges the nursing home violated “a clear mandate of Pennsylvania and United States public policy.”  Ballard seeks back pay, compensatory damages, and punitive damages. Claims like those brought by Ballard are on the rise.  During the first five months of the pandemic, 459 lawsuits were filed against employers due to alleged labor violations related to the coronavirus.  During the next four months, 776 lawsuits were filed.  In the first half of November alone, 158 complaints were filed.  Of the 1,235 total lawsuits, 116 are class actions.  For example, in September, workers in California, Michigan, and Georgia filed unrelated lawsuits in which they claimed they were fired for quarantining after contracting COVID-19. Whether brought by an individual plaintiff or on behalf of a purported class, these lawsuits most commonly assert that employers violated federal and state mandates, guidelines, and regulations regarding employee safety.  One such federal mandate is the Families First Coronavirus Response Act (FFCRA), passed by Congress in March.  The FFCRA requires employers with fewer than 500 workers to provide employees with a certain amount of compensated time off for various reasons linked to COVID-19, including if employees become ill.  Importantly, however, the FFCRA provides that certain employees—i.e., “health care providers and emergency responders”—may be excluded from entitlement to both emergency family leave and emergency paid sick leave.  Please see our e-alert on this topic, available here. In addition to FFCRA cases, employees have also filed lawsuits alleging that their employers violated the federal WARN Act (or similar state laws), which in certain circumstances requires that employers with 100 or more employees provide at least 60 days’ notice before conducting a mass layoff. Although lawsuits focused on COVID-19 largely remain at the early stages of litigation, health care providers can employ a number of proactive steps to reduce their potential exposure. Providers should understand their obligations under relevant federal and state law and provide employees protected leave as appropriate. When in doubt, we recommend that employers err on the side of granting the requested leave; Providers should revise company policies as necessary to incorporate the new regulations that apply to COVID-19 exposure and sick leave; To the extent feasible, providers should consider offering teleworking opportunities for eligible employees; Providers should implement a system for recording employees’ requests for leave and the reasons supporting those requests, i.e., an employee’s symptoms and the date for a test or doctor’s appointment. However, providers should not require employees to provide further documentation, such as certification that the employee sought a diagnosis or treatment from a healthcare provider; and Providers should be mindful of the risks of taking personnel actions that could lead to discrimination or retaliation lawsuits by workers who requested or took applicable leave. As always, providers should properly document their termination decisions.

The Centers for Medicare and Medicaid Services (“CMS”) published an Interim Final Rule in the Federal Register on September 2, 2020 to supplement and strengthen the agency’s enforcement of COVID-19 reporting requirements.  The final rule also modifies various aspects of Medicare reimbursement methodologies for health plans, physicians, and other providers.  This post summarizes each of these regulatory changes, which are effective as of September 2, 2020. New Enforcement Requirements for COVID-19 Related Data Reporting To assist public health officials in detecting and tracking COVID-19 outbreaks and save lives, CMS is adding new reporting requirements for healthcare facilities along with expanded CMS enforcement authority to ensure compliance with such reporting requirements. The Interim Final Rule addresses reporting and related enforcement for three general categories of healthcare entities: long term care (LTC) facilities, hospitals and critical access hospitals (CAHs), and laboratories. A. LTC Facilities Under CMS regulations issued in May, LTC facilities are required to electronically report COVID-related data to the Centers for Disease Control and Prevention (CDC) on a weekly basis. Facilities must report a variety of information, including suspected and confirmed COVID-19 infections among residents and staff, the number of COVID-19 resident and staff deaths, the personal protective equipment and hand hygiene supplies in the facility, and more. The Interim Final Rule allows CMS to impose civil money penalties (“CMPs”) if a LTC facility fails to submit its weekly report.  CMS may impose a minimum of $1,000 for an initial violation. For every subsequent time the facility fails to report the required data, the CMP imposed will increase by $500, up to a maximum of $6,500.  For example, a facility that fails to report for two consecutive weeks will be subject to a minimum CMP of $2,500: $1,000 for the first week and $1,500 for the second week. CMS waived the normal notice-and-comment process due to the urgent need to track and contain COVID-19 infection outbreaks. LTCs are subject to these new penalties for reporting failures effective September 2, 2020, and the penalties will continue to be in effect for up to one year beyond the end of the COVID-19 public health emergency (“PHE”). B. Hospitals and CAHs The Interim Final Rule also makes daily reporting of COVID-related data a Condition of Participation in the Medicare and Medicaid programs for hospitals and CAHs. To support broader surveillance of the spread of COVID-19, CMS will require hospitals and CAHs to report certain COVID-related information to the Department of Health and Human Services (“HHS”) daily, through a standardized format specified by HHS, set forth here. CMS does not have authority to impose CMPs on hospitals or CAHs who fail to provide this reporting. However, should a hospital or CAH fail to consistently report test results throughout the duration of the PHE, it will be non-compliant with the hospital and the CAH Conditions of Participation set forth at 42 CFR §§ 482.42(e) and 485.640(d), respectively, and consequently subject to CMS termination of its Medicare provider agreement. C. Laboratories Additionally, the Interim Final Rule modifies the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) to require all laboratories to report SARS-CoV-2 test results within 24 hours of a positive test result. Reports must be made throughout the PHE, as specified here.  If a laboratory fails to submit SARS-CoV-2 test results as required under the CLIA modifications, the Department of Health and Human Services may impose CMPs or other penalties on the laboratory. CMS states that CMPs for reporting violations will be $1000 for the first day of noncompliance, and $500 for each subsequent day the laboratory fails to report SARS-CoV-2 test results. The applicable statute allows for the imposition of CMPs of up to $10,000 for each violation. LTCs Must Test Residents and Staff for COVID-19 In addition to reporting COVID-related data, LTCs are required under the new rule to test their facility residents and staff for COVID-19.   Testing includes not only staff employees, but volunteers and those providing services under arrangements at the facility.  Testing must be conducted in a manner consistent with current professional standards of practice for COVID testing.   Documentation of testing and resulting must be provided in staff personnel records, and in resident medical records. CMS has published additional guidance here that addresses testing frequency, types of testing that should be conducted, and guidance on handling staff who refuse testing, among other topics. Limitation on Medicare Coverage of COVID-19 Testing Without an Order In a prior Interim Final Rule with Comment Period, CMS expanded coverage for COVID-19 testing for Medicare beneficiaries by eliminating the need for an order from a treating physician or other practitioner. CMS has now revised this policy, citing fraud and abuse concerns and clinical concerns that beneficiaries are receiving too many COVID-19 tests without medical attention and oversight.  Consequently, beginning September 2 and continuing for the duration of the PHE, Medicare will cover only one (1) COVID-19 diagnostic test without the order of a physician or other practitioner.   A single otherwise covered laboratory test each for influenza or a similar respiratory condition needed to obtain a final COVID-19 diagnosis, when performed in conjunction with a COVID-19 test, will also be covered.  Medicare will cover additional COVID-19 tests only with the order of a physician or other practitioner. Any COVID-19 test(s) that a beneficiary received prior to September 2, 2020 is disregarded for purposes of this new single COVID-19 test coverage rule. CMS points out that this coverage rule applies to the Medicare program only; COVID-19 testing coverage policies for group health plans, health insurance issuers, and other public programs must comply with applicable law. CMS is also allowing pharmacists and other practitioners allowed to order laboratory tests in accordance with state scope of practice and other laws to fulfill the requirements related to orders for covered COVID-19 tests for Medicare patients. Quality Reporting: Updates to the Extraordinary Circumstances Exceptions (ECE) Granted for Four Value-Based Purchasing Programs in Response to the PHE for COVID-19, and Update to the Performance Period for the FY 2022 SNF VBP Program Early in the PHE, CMS granted several “Extraordinary Circumstances Exceptions” (“ECEs”) which relieved facilities of certain data collection and reporting obligations so that more time and resources could be directed to patient care. CMS used such data reporting to score certain program performance, resulting in adjustments of Medicare payments pursuant to certain value-based and quality-related features of Medicare reimbursement methodologies.  CMS states that, although it was gathering data on these programs, it has concerns about the national comparability of data due to the geographic differences of COVID-19 incidence rates and hospitalizations and the impacts of varying state and local laws and policy changes implemented in response to COVID-19. Therefore, the Department proposes updating the ECEs it granted for the following value-based purchasing programs: The End-Stage Renal Disease Quality Incentive Program (ESRD QIP); The Hospital-Acquired Condition (HAC) Reduction Program; The Hospital Readmissions Reduction Program (HRRP); and The Hospital Value-Based Purchasing (HVBP) Program. Under the updated ECEs, CMS will only score data that was voluntarily reported for the fourth quarter of calendar year 2019. Further, CMS will exclude all data reported for the first or second quarter of calendar year 2020, due to the significant and variable impacts COVID-19 had on facilities during this period. In addition, the Interim Final Rule updates the performance period for the fiscal year 2022 SNF VBP Program, because CMS believes that the current measurement periods would not produce reliable results for measuring SNF quality of care as determined by hospital readmission rates.  The measurement periods are changing from October 1, 2019 through December 31, 2019 and July 1, 2020 through September 30, 2020 to April 1, 2019 through December 31, 2019 and July 1, 2020 through September 30, 2020. NCD Procedural Volumes for Facilities and Practitioners to Maintain Medicare Coverage The Interim Final Rule acknowledges that, because of the PHE, far fewer non-essential procedures have been performed over the past several months. As a result, hospitals and practitioners may not be able to meet certain procedural volume requirements that are set forth in certain national coverage determinations (“NCDs”), including: NCD 20.34 Percutaneous Left Atrial Appendage Closure (LAAC). NCD 20.32 Transcatheter Aortic Valve Replacement (TAVR). NCD 20.33 Transcatheter Mitral Valve Repair (TMVR). NCD 20.9.1 Ventricular Assist Devices (VADs). Typically, failure to meet the procedural volume requirements would prevent Medicare payment for those categories of procedures.  However, CMS will not enforce the procedural volume requirements contained in the four above-noted NCDs because of disruptions caused by the PHE. This waiver of enforcement only applies to facilities and practitioners that had met the volume requirements prior to the PHE for COVID-19. All other non-volume based coverage requirements under these NCDs remain in effect. Merit-Based Incentive Payment System (MIPS) Updates CMS is making changes to the Merit-Based Incentive Payment System (“MIPS”) for physicians and other clinicians, to reflect the manner in which Medicare beneficiaries are receiving primary care services during the PHE.  For the 2020 MIPS performance year and any subsequent performance year that starts during the PHE, CPT and HCPCS codes for communications technology-based services and telephone evaluation and management services are to be included in the definition of primary care services under MIPS.  This will allow those remote services to be included in CMS determinations of where Medicare beneficiaries receive a plurality of their primary care services for purposes of MIPS beneficiary assignment to physicians and other clinicians. CMS is also modifying one of the Improvement Activities in MIPS relating to COVID-19 clinical trial participation, so that clinicians can receive credit under this Improvement Activity not only for participating in a COVID-19 clinical trial, but also for participating in the care of patients diagnosed with COVID-19 and simultaneously submitting relevant clinical data to a clinical data registry for ongoing or future COVID-19 research. Recognizing Temporary Premium Credits as Premium Reductions CMS previously adopted policies allowing health insurance issuers offering health insurance coverage in the individual and small group markets on the American Health Benefit Exchanges established under The Patient Protection and Affordable Care Act (Pub. L. 111-148) to grant temporary premium credits for individuals and small businesses that may be struggling to pay premium during the PHE.  In this Interim Final Rule, CMS makes a number of technical changes and clarifications to ensure that health plan premium reporting takes into account any premium credits granted, including for purposes of medical loss ratio (MLR) reporting and rebates. Part C and Part D Health Plan Star Ratings Finally, CMS made changes to the Star Rating system for Medicare Part C and Part D health plans.  The Star Rating system allows CMS to publish comparative information to beneficiaries about Medicare Advantage and Medicare Part D health plans, and is the basis for determining quality bonus payments to Medicare Advantage plan, as well as beneficiary rebates. CMS currently excludes certain scores within the Stark Rating system if a plan has 60 percent or more of its enrollees living in a Federal Emergency Management Agency (FEMA)-designated Individual Assistance area.  Because of the PHE, the maintenance of this rule would remove almost all plans from those scoring metrics.  Consequently, CMS is removing that 60 percent rules for the 2022 Star Ratings (for which 2020 is the measurement year) to avoid having to exclude the vast majority of plans from the methodology. This recent Interim Final Rule clearly indicates that CMS wants to ensure consistent reporting of COVID-19 related data from laboratories, hospitals and long term care facilities.  It also illustrates the profound and widespread degree to which the PHE continues to impact Medicare reimbursement methodologies and systems. If you have any questions about the Interim Final Rule or any of the topics addressed in this post, please contact the authors or any member of the Dorsey & Whitney Health Transactions & Regulations Practice Group.

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey's Robert Webber, Ieva Aubin, Penni Frank, and Erin Bukacek for the following e-update: The U.S. Department of Health and Human Services (HHS) has made a significant change regarding eligibility for clinical J-1 waivers for foreign educated physicians who have completed graduate medical programs or training in the United States. This development changes the landscape for J-1 visa waiver availability nation-wide...[Continue Reading]    

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Andrew Brantingham, Ross C. D'Emanuele, and Alex Hontos for the following post from Dorsey's FCA Now blog: The CARES Act allocated $100 billion in relief funds to hospitals and other healthcare providers, to be distributed by the Department of Health and Human Services (“HHS”) through the Public Health and Social Services Emergency Relief Fund (or “Provider Relief Fund”). Many healthcare providers across the country have received payments from the Fund...[Continue Reading]

As we described in our prior blog post, on March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published multiple COVID-19 Blanket Waivers for Health Care Providers. CMS announced another round of Blanket Waivers on April 30, which are available here. These waivers provide additional flexibility to health care providers responding to the COVID-19 pandemic by expanding access to telehealth services and giving providers and facilities relief from many reporting and audit requirements so they can focus on patient care. The following is a summary of the new Blanket Waivers available to providers. These Blanket Waivers are retroactively effective back to March 1, 2020 and will continue through the end of the emergency declaration. Flexibility for Medicare Telehealth Services Eligible Practitioners CMS is expanding the types of health care practitioners who may be reimbursed for providing Medicare telehealth services to all practitioners who are eligible to bill Medicare for non-telehealth services. Thus, physical therapists, occupational therapists, speech language pathologists, and others may now furnish and receive reimbursement for Medicare telehealth services. Audio-Only Telehealth for Certain Services CMS is now permitting more services to be provided by audio-only technology. Several evaluation and management services, behavioral health counseling, and educational services no longer require a two-way, real-time interactive communication between the patient and practitioner. For a list of billing codes for these audio-only services, please review the CMS list of Medicare telehealth services, available here. Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) Certain Staffing Requirements In an effort to address potential staffing shortages, CMS is waiving the requirement that certain practitioners (NP, PA, or certified nurse-midwife) be available to furnish patient care services at least 50 percent of the time a Rural Health Clinic operates. However, a physician, nurse practitioner, physician assistant, certified nurse-midwife, clinical social worker, or clinical psychologist must still be available to furnish patient care services at all times the Rural Health Clinic operates. Long-Term Care Facilities and Skilled Nursing Facilities (SNFs) and/or Nursing Facilities (NFs) Quality Assurance and Performance Improvement (QAPI) CMS is modifying QAPI program requirements to the extent necessary to narrow the scope of the QAPI program to focus on adverse events and infection control. This will help ensure facilities focus on aspects of care delivery most closely associated with COVID-19 during the PHE. In-Service Training Nursing assistants will now have more time to complete their required 12 hours of in-service training. CMS has extended the deadline for completing this training until the end of the first full quarter after the declaration of the PHE concludes. Detailed Information Sharing for Discharge Planning for Long-Term Care (LTC) Facilities In order to help long-term care facilities expedite the discharge and movement of residents among care settings, CMS is waiving the discharge planning requirement that facilities must assist residents and their representatives in selecting a post-acute care provider using data such as standardized patient assessment data, quality measures, and resource use. All other discharge planning requirements remain in place. Clinical Records Long-term care facilities may now take ten working days to provide a resident a copy of their records after requested. Previously, facilities were required to provide a copy within two working ways when requested by the resident. Home Health Agencies (HHAs) Training Requirement for Home Health Aides Medicare conditions of participation for HHAs state that each Home Health Aide must receive 12 hours of in-service training every 12 months. To give both aides and the nurses that provide the training more time to perform patient care, this training requirement is postponed, and the new deadline for aide in-service training is the end of the first full quarter after the declaration of the PHE concludes. Detailed Information for Discharge Planning The requirement to provide patients with detailed information regarding discharge planning in selecting a post-acute care provider (such as quality and resource use measures of potential providers) is temporarily waived during the PHE. All other discharge planning requirements remain applicable. Clinical Records HHAs may take ten business days to provide a patient with copies of their medical records, instead of four business days. Hospice Training Requirement for Home Health Aides Hospice conditions of participation requiring the annual assessment and in-service training and education of all individuals furnishing care is postponed until the end of the first full quarter after the declaration of the PHE concludes. HHAs and Hospice Onsite Supervisory Visits For both HHAs and Hospices, the condition of Medicare participation that requires a registered nurse (or for HHA any other appropriate skilled professional) to make an annual onsite supervisory visit for each aide is postponed. Postponed onsite assessments must be completed no later than 60 days after the expiration of the PHE. Quality Assurance and Performance Improvement (QAPI) To allow HHAs and Hospices to focus on COVID-19 effort, the requirement that HHAs and Hospices maintain an effective, ongoing, data-driven QAPI program is modified to narrow the scope of the mandated QAPI program to infection control issues. Remaining QAPI activities should focus on adverse events. Ambulatory Surgical Centers (ASCs) Medical Staff During the PHE, CMS is waiving the ASC conditions of coverage requiring ASCs to periodically reappraise medical staff privileges. This will allow physicians whose privileges will expire to continue practicing at the ASC without the need for reappraisal. Community Mental Health Centers (CMHCs) Quality Assurance and Performance Improvement (QAPI) While maintaining the general requirement that CMHCs maintain an effective, ongoing, data-driven QAPI program, CMS is waiving the specific detailed requirements for QAPI program organization and content to provide flexibility for CMHCs to focus QAPI resources on circumstances that arise during the PHE. CMHC modifications to QAPI programs must be consistent with a state’s emergency preparedness or pandemic plan. Home Services CMS is waiving the prohibition on CMHCs providing partial hospitalization services and other CMHC services in an individual’s home. This will allow clients to safely shelter in place during the PHE while receiving needed care and services from the CMHC. CMHCs must still assess client needs, implement and update each client’s individualized active treatment plan, and promote client rights, including a client’s right to file a complaint. 40% Rule To promote access to services, the requirement that CMHCs provide at least 40% of their items and services to individuals who are ineligible for Medicare benefits is waived. Physical Environment for Multiple Providers/Suppliers Inspection, Testing & Maintenance (ITM) under the Physical Environment Conditions of Participation: CMS is waiving the following physical environment requirements for Hospitals, CAHs, inpatient hospices, ICF/IIDs, and SNFs/NFs to reduce disruption of patient care and potential exposure/transmission of COVID-19. Requirements to maintain facilities and equipment to ensure an acceptable level of safety and quality are temporarily modified as necessary to permit these facilities to adjust scheduled inspection, testing and maintenance (ITM) frequencies and activities for facility and medical equipment. These facilities may adjust scheduled ITM frequencies and activities required by the applicable Life Safety Codes and Health Care Facilities Codes. The following are not included in this waiver:  Sprinkler system monthly electric motor-driven and weekly diesel engine-driven fire pump testing. Portable fire extinguisher monthly inspection. Elevators with firefighters’ emergency operations monthly testing. Emergency generator 30 continuous minute monthly testing and associated transfer switch monthly testing. Means of egress daily inspection in areas that have undergone construction, repair, alterations or additions to ensure its ability to be used instantly in case of emergency. Requirements to have an outside window or outside door in every sleeping room are waived to permit these providers to utilize space not normally used for patient care for temporary care or quarantine. If you have any questions about the CMS Blanket Waivers, please contact the authors or your regular Dorsey & Whitney attorney. We continue to closely monitor the rapidly evolving legal landscape related to the COVID-19 pandemic. You can access Dorsey’s health law blog related to health law updates, available here. You can also access Dorsey’s coronavirus resource center, which contains a wide variety of legal resources related to the coronavirus outbreak, available here.

On March 9, 2020, the Centers for Medicare and Medicaid Services (“CMS”) issued a memorandum describing hospitals’ continuing obligations with respect to the Emergency Medical Treatment and Labor Act (“EMTALA”) during the COVID-19 public health emergency (“PHE”). Check out our previous blog post on this topic here. Last week, in response to a growing number of questions from hospitals and critical access hospitals (“CAHs”), CMS released additional guidance in the form of frequently asked questions (“FAQs”) concerning the implications of COVID-19 on EMTALA compliance. The FAQs address questions CMS has received on a variety of topics, including patient presentation to the emergency department (“ED”), the applicability of EMTALA in different facilities, determining who is a qualified medical professional, as well as information on medical screening exams, patient stabilization, transfers, and other EMTALA-related topics. Below, we set forth a sampling of some of those questions and answers. A full list of the FAQs, covering all of the EMTALA topics CMS addressed in its FAQs, including topics not covered in this blog, can be found here. Patients Presenting to the Emergency Department Q. May hospitals place a sign outside an ED stating “COVID-19 testing is not being offered to asymptomatic patients”? A. Yes. In general, signage may be used to inform individuals about the availability of COVID-19 testing or to provide direction to alternative sites on the hospital’s campus where medical screening examinations (“MSE”) are available; for example, directing the patient to a parking lot test site for COVID-19. CMS emphasized, however, that it is a violation of EMTALA for hospitals to use signage that presents a barrier to individuals, including potential COVID-19 patients, from coming to the ED or for hospitals to otherwise refuse to provide a MSE to anyone who comes to the ED for examination or treatment. Hospitals may encourage the public to go to off-campus sites to be screened for COVID-19 instead of to the hospital. Normally, a hospital may not tell individuals who have already entered an ED to go to the off-site location for the MSE—such a redirection usually may only be to an on-campus alternative site. However, CMS has approved via a section 1135 waiver for the COVID-19 public health emergency (“PHE”) the ability to re-direct patients to an offsite location for screening, in accordance with a state emergency preparedness or pandemic plan. Q. Is a hospital’s ability to refer an individual to an alternative off-campus screening site limited strictly to those individuals with COVID-19 symptoms? A. No. CMS clarified that any patients may be redirected to an off-campus screening location to receive an MSE under the section 1135 waivers regardless of the presence of COVID-19 symptoms. For example, ambulance patients may be referred off-campus (i.e., without any off-loading or any evaluation before the referral). Public health officials, emergency medical services (“EMS”) systems, and hospitals may develop protocols, including COVID-19 protocols, governing where EMS should transport individuals for emergency care. As a reminder, for a hospital owned-and-operated ambulance operating in accordance with community-wide EMS protocols that directs the transport of individuals to a hospital other than the hospital that owns the ambulance (for example, to the closest appropriate hospital), the presenting individual is considered to have come to the ED of the hospital to which the individual is transported. The receiving hospital is subject to EMTALA at the time the individual is brought onto hospital property. Where Does EMTALA Apply? Q. Can EMTALA be relaxed to allow hospitals to refer patients to urgent care facilities? A. Hospitals may encourage the public to go to off-campus sites for COVID-19 screening instead of the hospital so long as those sites are operating in accordance with the state or local pandemic plan, are identified specifically by the hospital as the place to receive an MSE, and have the capability to provide that MSE. Additionally, CMS has approved a section 1135 waiver for the duration of the public health emergency granting hospitals the ability to re-direct patients to an off-site location. Q. What is the definition of “on campus”? A. The definition of campus can be found at 42 C.F.R. § 413.65(a)(2) and means the physical area immediately adjacent to the provider’s main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings and any other areas determined on a case-by-case basis. Per 42 C.F.R. § 489.24(b), “Hospital property” means the entire main hospital campus, including the parking lot, sidewalk, and driveway, but excluding other areas or structures of the hospital’s main building that are not part of the hospital, such as physician offices, rural health centers, skilled nursing facilities, or other entities that participate separately under Medicare, or restaurants, shops, or other nonmedical facilities. During the COVID-19 PHE, non-hospital properties, such as hotels, dormitories, and field hospitals at places like parks, are becoming extensions of hospitals, otherwise known as temporary expansion sites. This is permissible under the section 1135 waiver of the provider-based regulations at 42 C.F.R. § 413.65 and certain requirements under the Medicare conditions of participation at 42 C.F.R. § 482.41 and § 485.623. For the duration of the COVID-19 PHE, these waivers allow a hospital to establish and operate as part of the hospital any location meeting the Conditions of Participation (CoPs) for hospitals that continue to apply during the PHE. These waivers also allow a hospital to change the status of its current provider-based department locations to the extent necessary to address the needs of hospital patients as part of the state or local pandemic plan. As such, it is acceptable to triage and treat patients in these temporary expansion sites. Q: Can multiple hospitals with different Medicare provider numbers join together to establish the off-site location in accordance with the state emergency plan? If so, what EMTALA implications would result for each hospital involved? A: Yes. Temporary expansion sites may serve multiple hospitals if it is consistent with their state emergency plan. Unless the off-campus site is already a dedicated emergency department (“DED”) of a hospital, as defined under EMTALA regulations at 42 C.F.R. § 489.24(b), EMTALA requirements do not apply. If an individual being treated at a temporary expansion site needs additional medical attention on an emergent basis, the site is required, under the Medicare CoPs, to arrange referral/transfer. When multiple hospitals join to establish an off-site location, the hospitals should operate in distinct clinical spaces within the location or designate one facility that will assume responsibility for ensuring compliance with the CoPs including EMTALA requirements (if applicable). If the space is shared across multiple hospitals, CMS notes that noncompliance problems at a temporary expansion sites may implicate associated certified hospitals depending upon the type of noncompliance. Q: How does EMTALA apply if a community has exhausted its supply of beds and/or ventilators and a patient presents with an emergent condition that needs these resources for stabilization? A: Hospitals are required to provide stabilizing treatment to individuals determined to have an emergency medical condition within the hospital’s capability prior to arranging an appropriate transfer. In situations where facilities may not have the necessary services or equipment, they should provide stabilizing interventions within their capability until the individual can be transferred. For example, in cases where the hospital does not have available ventilators, establishing an advanced airway and providing manual ventilation can assist in stabilizing the individual until an appropriate transfer can be arranged. Q: If a hospital sets up an alternative off-campus testing site, is that site regulated by the hospital conditions of participation? A: Yes. Alternative care sites and temporary extension sites that are established by the hospital are still required to follow the applicable hospital CoPs to the extent not waived under the blanket waivers issued by CMS. Community testing centers established by the state would be under the state emergency and pandemic plan and are not required to meet the hospital CoPs. Qualified Medical Professionals (QMPs) Q: Has CMS removed the requirement to have a QMP, approved by the governing body, perform the MSE? A: No. QMPs responsible for performing MSEs must still be approved by the hospital’s governing body. Hospitals may request a case-by-case section 1135 waiver to allow MSEs to be performed by qualified medical staff authorized by the hospital, who are acting within their scope of practice and licensure, but are not designated in the hospital bylaws to perform the MSEs. Medical Screening Exams CMS has received a number of questions from providers regarding how MSEs may be performed in light of the COVID-19 pandemic. Q: Can emergency physicians and other health care practitioners conduct medical screening exams (MSEs) under EMTALA via telehealth? A: Yes. QMPs, including emergency physicians, can perform MSEs using telehealth equipment. The QMP may be on-campus and using technology to self-contain or offsite due to staffing shortages. The MSE may be performed solely via telehealth if clinically appropriate. If the patient is seen by a QMP located on campus via electronic two-way technology, the service would not be considered a telehealth visit. Regardless of location, the QMP must be performing within the scope of his/her state practice act and approved by the hospital’s governing body to perform MSEs. Q: Can CMS waive certain elements of EMTALA to allow for more flexibility in meeting the current medical screening exam (MSE)? A: CMS has temporarily waived some EMTALA requirements to allow screening for patients at a location offsite from the hospital’s campus to prevent the spread of COVID-19, so long as it is not inconsistent with a state’s emergency preparedness or pandemic plan. Under the waiver, hospital EDs may redirect incoming patients to alternative screening sites staffed by QMPs, to ensure symptomatic or COVID-19-positive patients are directed to appropriate settings of care. Q: Can emergency physicians perform medical screening exams outside of the ED, such as in tents in the parking lot, under EMTALA? A: Yes. A hospital may set up alternative sites on its campus to perform MSEs. Individuals may be redirected to these sites. Whether the individual is seen at the alternate on-campus site or in the ED, they should be logged in where they are seen. Individuals do not need to present to the ED, first, and if they do present to the ED, they may still be redirected to the on-campus alternative screening location for logging and subsequent screening. This is a triage function, and the person providing the redirection from the ED should be qualified to recognize individuals who are obviously in need of immediate treatment in the ED. Hospital non-clinical staff stationed at other entrances to the hospital may provide redirection to the on-campus alternative screening location for individuals seeking COVID-19 testing. Q: Can the MSE be conducted by a Registered Nurse (RN)? A: Yes. MSEs must be conducted by qualified personnel, which may include physicians, nurse practitioners, physician’s assistants, or RNs trained to perform MSEs, acting within the scope of their state licensure law, and as approved by the hospital’s governing body. Hospitals may request a waiver to allow MSEs to be performed by other personnel, including trained RNs not previously approved by the governing body to perform MSEs. Q: If there is an on-site COVID-19 testing location (e.g., tent outside main ED), would EMTALA apply if individuals are only requesting COVID-19 testing? Would a MSE be required? A: EMTALA would apply if a patient who was solely seeking COVID-19 testing made a request for medical treatment while on the hospital campus or demonstrated a medical condition that a prudent layperson would believe, based on the individual’s appearance or behavior, indicated that the individual needed examination or treatment of a medical condition. However, patients who present solely for the purpose of COVID-19 testing and are not making a request for treatment of a medical condition, do not necessarily require a MSE. If the person complains of or exhibits any symptoms of a medical condition, then that person should receive an appropriate MSE to determine whether an emergency medical condition (“EMC”) exists. The EMTALA obligation is satisfied if the MSE determines no EMC exists. Q: Can a hospital conduct an MSE if the patient remains in an automobile and meet its EMTALA obligations? A: It depends. The MSE does not have to take place in the ED to satisfy EMTALA. The content of the MSE varies according to the individual’s presenting signs and symptoms, and it can be as simple or as complex, as needed, to determine if an emergency medical condition exists. MSEs must be conducted by qualified personnel, which may include physicians, nurse practitioners, physician’s assistants, or RNs trained to perform MSEs and acting within the scope of their state practice act. If a clinically-appropriate MSE can be performed in an automobile to determine whether or not an emergency medical condition exists, that MSE would be permissible under EMTALA. Q: For off-campus, hospital-controlled sites, can a person first presenting to the ED be redirected from the ED to the off-campus site where the MSE will be completed? A: Yes. Hospitals may redirect patients presenting to the ED to an off-campus site where an MSE will be completed. Normally, a hospital may not tell individuals who have already entered an ED to go to the off-site location for the MSE, such a redirection usually only occurs to an on-campus alternative site. However, CMS has issued a blanket section 1135 waiver for the duration of the COVID-19 PHE the ability to re-direct patients to an offsite location for screening, in accordance with a state emergency preparedness or pandemic plan. Hospitals are generally able to manage the separation and flow of potentially infectious patients through alternate screening locations on the hospital campus during the COVID-19 PHE. Q: Is there a specific time frame in which the MSE has to take place if a patient is referred to an off-campus site? Would it have to happen that same day? A: There is no specified time frame in which the MSE has to occur after the referral from the hospital to an off-campus site. However, triage entails the clinical assessment of the individual’s presenting signs and symptoms at the time of arrival at the hospital, in order to prioritize when the individual will be seen by a physician or other QMP. Individuals presenting must be provided an MSE appropriate to the individuals’ presenting signs and symptoms, as well as the capability and capacity of the hospital. The MSE must be the same MSE that the hospital would perform on any individual coming to the hospital’s dedicated emergency department with those signs and symptoms, regardless of the individual’s ability to pay for medical care. If a hospital applies a nondiscriminatory screening process that is reasonably calculated to determine whether an EMC exists, it has met its obligations under EMTALA. The required MSE and stabilizing treatment should not be delayed. If the MSE is appropriate and does not reveal an EMC, the hospital has no further obligation. Q: If a hospital set up a COVID-19 testing location offsite, and patients only present to the hospital for testing without requesting additional services, do those patients need an MSE before we refer them offsite? A: Those patients would not be subject to an MSE in this case unless they are requesting examination or treatment for a medical condition or demonstrate a medical condition for which a MSE is necessary. EMTALA requires that all persons who present to the hospital or ED for a medical condition be provided an MSE to determine whether they have an EMC. Transfer and Stabilization of Patients Q: Has CMS waived elements of EMTALA to allow for more flexibility in the transfer and stabilization requirements? A: No. CMS has not waived EMTALA transfer or stabilization requirements. Hospitals are expected to provide stabilizing treatment within their capabilities and capacity prior to the initiation of a transfer to another hospital. However, when a section 1135 waiver has been issued, sanctions for an inappropriate transfer of a patient or for the direction or relocation of a patient to receive a MSE at an alternate location do not apply if certain conditions are met, as enumerated at 42 C.F.R. §489.24(a)(2)(i)(A)-(E). Q: Is transfer to a designated facility permissible regardless of COVID-19 status, as long as positives go to designated positive facilities and negatives go to designated negative facilities? A: Yes. A patient transfer under the state emergency and pandemic plan would apply to all patients regardless of COVID-19 status following an appropriate MSE and determination that patient is stable for an appropriate transfer. Q: When could a hospital refer a patient who comes to the ED for medical treatment to an urgent care center? A: Hospitals must provide a MSE to all patients who come to the ED requesting treatment for a medical condition or where the individual is demonstrating presence of a medical condition to determine if an EMC exists. The content of the MSE varies according to the individual’s presenting signs and symptoms, but should be provided within the capabilities of the hospital’s ED, including ancillary services routinely available to the hospital. Once the MSE is complete and if the patient is determined not to have an EMC, the hospital’s EMTALA obligation ends and the patient may be referred to an urgent care center for continued care of non-emergency illnesses or injuries. However, a section 1135 waiver gives the ability for hospitals to re-direct patients that have presented to the ED to an offsite location for the MSE in accordance with a state emergency preparedness or pandemic plan. Under the section 1135 waiver, hospital EDs may redirect incoming patients to alternative screening sites staffed by qualified medical personnel, to ensure that symptomatic or COVID-19-positive patients are directed to appropriate settings of care. Waivers Under Section 1135 of the Social Security Act Q: Has EMTALA been broadly waived? A: No. CMS has approved a section 1135 waiver for the COVID-19 PHE, which temporarily includes the ability to re-direct patients to an offsite location for screening in accordance with a state emergency preparedness or pandemic plan. Hospitals are still expected to provide an MSE to any individual who comes to the emergency department and requests examination or treatment, or has a request for examination or treatment made on their behalf. The purpose of the MSE is to determine if an emergency medical condition exists. If an EMC is determined to exist, the hospital must provide stabilizing treatment within the hospital capabilities or an appropriate transfer per 42 C.F.R. § 489.24. While certain aspects of EMTALA may be waived under the section 1135 waiver, federal civil rights laws have not been waived. Hospitals that receive federal financial assistance are still obligated to comply with federal civil rights laws, including Section 504 of the Rehabilitation Act, Title VI of the Civil Rights Act of 1964, Section 1557 of the Affordable Care Act and the Hill-Burton Act. Hospitals do not have to initiate a disaster plan before the section 1135 waiver becomes effective and hospitals are not required to provide notification to CMS upon initiation of the disaster plan. The flexibilities and blanket waivers released by CMS are retroactive to March 1, 2020. The waivers will end no later than the termination of the COVID-19 PHE, or 60 days from the date the waiver or modification is first published, unless the Secretary of HHS extends the waiver by notice for additional periods of up to 60 days, up to the end of the emergency period. Any additional formal guidance, revisions to existing guidance, or additional clarifications will be released via a QSO memorandum or other CMS approved communication. We at Dorsey are continuing to monitor the developments related to COVID-19. If you have any questions about the issues addressed in this blog, please contact the authors or your regular Dorsey attorney. You can access Dorsey’s coronavirus resource center, which contains a wide variety of legal resources related to the coronavirus outbreak, available here. You can also access Dorsey’s health law blog related to health law updates, available here.

As we explained in our prior blog post, on March 30, 2020, the Centers for Medicare & Medicaid Services (“CMS”) issued certain blanket waivers of sanctions under the federal physician self-referral law (or “Stark Law”) for “COVID-19 Purposes” (the “Stark Blanket Waivers”), which are available here. On April 21, 2020, CMS issued explanatory guidance, available here, on the scope and application of the Stark Blanket Waivers to certain financial relationships (the “Explanatory Guidance”). In addition to answering a variety of questions raised by the initial announcement of the Stark Blanket Waivers, the Explanatory Guidance provides an important reassurance to stakeholders. CMS states: “The Secretary will work with the Department of Justice to address False Claims Act relator suits where parties using the blanket waivers have a good faith belief that their remuneration or referrals are covered by a blanket waiver.” Despite this reassurance, however, it is crucial that parties seeking to rely on a Stark Blanket Waiver ensure that their arrangement, in fact, relates to “COVID-19 Purposes” (as defined in the Stark Blanket Waivers document), falls within the parameters of a specifically enumerated waiver within the Stark Blanket Waivers document, and that all non-waived requirements of an applicable Stark Law exception are met. We also note that, as CMS reminds parties in the Explanatory Guidance, relying on a Stark Blanket Waiver may not be necessary for certain arrangements related to COVID-19 Purposes, if these arrangements satisfy the requirements of an existing Stark Law exception. The following information summarizes the Explanatory Guidance. A. Compliance with Non-Waived Requirements of an Applicable Exception Many of the Stark Blanket Waivers eliminate or alter some, but not all, of the existing requirements of particular Stark Law exceptions. CMS warns that financial relationships or referrals must satisfy all non-waived requirements of an applicable exception in order to avoid implicating the Stark Law’s referral and billing prohibitions. We note that this includes, for example, meeting the “set in advance” requirement of applicable compensation exceptions, as this requirement is not waived by any of the Stark Blanket Waivers. B. Amendment of Compensation Arrangements The Explanatory Guidance clarifies when parties may modify the remuneration terms of an existing arrangement during the COVID-19 emergency period, and whether such terms can be amended during the emergency period and again at the conclusion of the emergency period to return to the original terms. This guidance applies when parties are relying on a compensation exception that has both a one-year term requirement and a “set in advance” requirement (such as the personal services arrangements exception). CMS points to the preamble guidance in the Fiscal Year 2009 Inpatient Prospective Payment System final rule (“FY 2009 IPPS Rule”), which CMS interprets as allowing for a second or subsequent amendment of the compensation terms of an arrangement, even within the first year of an initial amendment of those terms, as long as each time those terms are amended, “all requirements of an applicable exception are satisfied, the amended remuneration is determined before the amendment is implemented, the formula for the amended remuneration does not take into account the volume or value [of] referrals or other business generated by the referring physician, and the overall arrangement remains in place for at least 1 year following the amendment.” CMS reiterates that if parties amend a compensation arrangement during the emergency period, all non-waived requirements of an applicable exception must be met. The compensation terms of the arrangement may again be amended after the public health emergency is over. This further amendment may restore the original terms of the arrangement or make additional changes, as long as each of the criteria from the FY 2009 IPPS Rule (described above) are met. Finally, CMS points out that a modification of an existing arrangement could instead be analyzed as an additional compensation arrangement, for which the parties could use the Stark Blanket Waivers (if all applicable requirements are met). C. Applicability of Blanket Waivers to Indirect Compensation Arrangements The Explanatory Guidance states that the Stark Blanket Waivers do not apply to indirect compensation arrangements, and only apply to direct compensation arrangements. Parties can, however, seek an individual waiver of sanctions related to indirect compensation arrangements. The Explanatory Guidance goes on to note that many compensation arrangements that may appear to be indirect may be analyzed as direct compensation arrangements under the “stand in the shoes” provisions of the Stark Law. D. Repayment Options for Loans between a DHS Entity and a Physician (or the Immediate Family Member of a Physician) Two Stark Blanket Waivers (waivers #10 and #11) involve remuneration in the form of a loan with an interest rate below fair market value or on terms that are unavailable from a lender that is not in a position to make referrals to or generate business for the party making the loan. CMS states that these waivers do not require cash payments to the lender to satisfy a borrower’s debt. Loans may be repaid through in-kind payments, as long as the aggregate value of the in-kind payments is consistent with the amount of the loan and the arrangement is commercially reasonable. CMS provides that an example in-kind payment could be the maintenance of a medical practice and continuing to serve patients in the community where the entity is located. E. Repayment of Loans, Rent Abatement, or Other Amounts Due Following the End of the Emergency Period CMS clarified that, if parties use the Stark Blanket Waivers such as the loan arrangements described above, repayment obligations do not need to be completed prior to the termination of the Stark Blanket Waivers (which will be at the end of the public health emergency that was declared related to the COVID-19 outbreak). Many parties expressed concern that, after the termination of the Stark Blanket Waivers, the compensation arrangements entered into would no longer satisfy the requirements of an applicable exception because the interest charges or other charged amounts would not be consistent with the fair market value of the remuneration provided. The Explanatory Guidance provides that appropriate repayment terms agreed to before the termination of the Stark Blanket Waivers may continue beyond the termination of the waivers. However, disbursement of loan proceeds or additional remuneration after the termination of the Stark Blanket Waivers must satisfy all requirements of the applicable Stark exception. F. Restructuring of Existing Recruitment Arrangements with Income Guarantees CMS also responded to inquiries about the extension or restructuring of existing physician recruitment arrangements, such as whether a hospital could extend an income guarantee to address a recruited physician’s medical practice interruption due to the COVID-19 pandemic. The Explanatory Guidance states that CMS maintains its position that, under the Stark Law exception for physician recruitment, the terms of a recruitment arrangement cannot be altered once the physician has relocated their practice. Some Stark Blanket Waivers, however, may be available for remuneration from a hospital (or other entity) to assist a relocated physician whose medical practice is disrupted due to the pandemic in order to maintain the availability of medical care and related services for patients and the community. * * * For help determining whether an existing or proposed arrangement complies with a Stark Blanket Waiver and/or for inquiries regarding individual waiver requests, please contact the authors of this post or your regular Dorsey attorney. We continue to closely monitor the legal landscape related to the COVID-19 pandemic. You can access Dorsey’s health law blog providing health law updates, available here. You can also access Dorsey’s coronavirus resource center, containing a wide variety of legal resources related to the coronavirus outbreak, available here.

ERISA litigators know that a war has been raging between “out-of-network” medical providers, on one hand, and the entities that insure and administer group health plans, on the other (collectively, “Insurers”). For years, out-of-network providers have been suing plans and Insurers claiming they were “underpaid” for their medical services, often to the tune of millions of dollars. Hundreds of these cases have cropped up around the country in recent years. COVID-19 has now opened up a new front in this war, and the first skirmishes have already started. On April 10, 2020, Columbus Specialty Hospital (“Columbus”) filed a complaint in New Jersey state court seeking $36 million from various New Jersey insurance companies (the “Defendant-Insurers”) for payment of treatment it provided during the “COVID-19 crisis.” See Columbus Specialty Hosp. v. Amerigroup Corp., et al., No. ESX-L-002635-20 (N.J. Sup. Ct. April 10, 2020). According to Columbus, it provides “long term acute care” to “immunocompromised seniors”—the “prime targets for COVID-19 infection.” Columbus claims the Defendant-Insurers grossly underpaid it “for the live-saving treatment” it provided to those “vulnerable patients.” Columbus’s lawsuit is similar in some ways to the out-of-network provider cases that have cropped up around the country—but it adds a few new twists. The Common Elements Columbus’s lawsuit shares common features with the out-of-network provider lawsuits that came before it. Like the providers in those cases, Columbus does not directly sue for benefits under the terms of the health plans at issue. Instead, it asserts various contractual and quasi-contractual claims, alleging (among other things) that the Defendant-Insurers promised to pay Columbus its “usual and customary rates” for the services in question. This is a common tactic by out-of-network providers because their “usual” rates are much higher than the rates called for in the plan documents. In another relatively common move, Columbus asserts claims under state “prompt pay” statutes, which regulate the length of time in which an Insurer must pay providers for submitted claims. The New Elements While Columbus’s lawsuit shares a common structure with other out-of-network provider cases, it introduces new elements and could set new trends in this area of litigation. First, Columbus tries to bolster its claims by highlighting the emotional aspects of the “national and state emergency” related to COVID-19. According to Columbus, the Defendant-Insurers’ failure to pay does not simply affect its bottom line; it means members of the “greatest generation” are not receiving “the live-saving care” they deserve. Columbus also accuses the Defendant-Insurers of putting health care workers at risk by preventing Columbus from purchasing personal protection equipment. By tying its claims to the COVID-19 crisis, Columbus is hoping to tilt the scales of equities in its favor—a potentially effective move, especially for claims tried before a jury. Expect other medical providers to follow suit and tie their claims to the COVID-19 crisis. Second, Columbus’s lawsuit indicates that out-of-network providers may be shifting tactics for how they attempt to bind Insurers to “contractual” promises to pay the providers’ rates. As mentioned above, these out-of-network provider lawsuits often turn on whether the Insurer and provider formed a “contract” through communications about reimbursement rates. Traditionally, providers have alleged that such a contract or promise arose from phone calls with an Insurer’s billing department, during which the Insurer allegedly confirmed a patient’s coverage and reimbursement rates. Here, by contrast, Columbus claims it actually faxed formal contracts to the Defendant-Insurers, which they accepted by their conduct. This tactic is plainly an attempt to avoid the contractual formation and ERISA preemption defenses that defendants usually assert in these cases. Expect other out-of-network providers to employ similar tactics in their efforts to bind Insurers to commitments outside the four corners of the relevant health plan document. Third, Columbus’s lawsuit illustrates the astonishing size of provider bills for COVID-19 treatments and the limited time that Insurers have to process those claims. Columbus alleges, for example, that it billed $8.9 million for one patient for services related to COVID-19. While that sum is just an allegation, it is nonetheless a staggering number. And Columbus invokes New Jersey’s “prompt pay” statutes to insist that the Defendants-Insurers should have processed its multi-million dollar bills at breakneck speeds. This combination of large bills and pressure to pay those bills quickly puts enormous pressure on Insurers’ billing departments. This flurry of large bills also opens the door to fraud and abuse by unscrupulous providers. Insurers will have to find a way to manage this risk, while still ensuring that proper bills are paid in a timely fashion. But inevitably, Insurers will discover overpayment after the fact, which may trigger recoupment actions by Insures and the group health plans, which they administer. Should you seek additional information about these types of claims, feel free to contact us.

On Friday, April 24, 2020, President Trump signed into law the “Paycheck Protection Program and Health Care Enhancement Act,” colloquially referred to as “Phase 3.5.” Phase 3.5 comes on the heels of three much larger bills passed into law intended to address the effects of the ongoing coronavirus pandemic. The first three phases, the Coronavirus Preparedness and Response Supplemental Appropriations Act, the Families First Coronavirus Response Act, and the CARES Act, provided much-needed funding to hospitals and health care providers affected by COVID-19. Phase 3.5 continues this funding by providing additional emergency appropriations totaling $484 billion, the majority of which ($384 billion) goes to replenishing the Paycheck Protection Program, Economic Injury Disaster Loans, and Emergency Grants funds as established in the CARES Act. Phase 3.5 allocates an additional $75 billion to the Public Health and Social Services Emergency Fund for providers to prevent, prepare for, and respond to coronavirus. The Phase 3.5 package also includes $25 billion for COVID-19 testing, $11 billion of which is earmarked for states to aid in their efforts to ramp up testing. A breakdown of the major funding provisions included in the Phase 3.5 bill is below. Paycheck Protection Program Phase 3.5 appropriates an additional $321 billion to replenish the funds for the Paycheck Protection Program (“PPP”). The PPP was originally funded by the CARES Act with $349 billion to protect small businesses and help them avoid layoffs and rehire employees. The loan amounts distributed under the PPP will be forgiven so long as the loan proceeds are used to cover payroll costs, and most mortgage interest, rent, and utility costs, and employee and compensation levels are maintained. Phase 3.5 specifically sets aside $60 billion of these funds for small, midsize, and community lenders in an effort to avoid forcing smaller companies to compete with larger companies for the same funds. Economic Injury Disaster Loans Program Phase 3.5 appropriates $50 billion for Economic Injury Disaster Loans and an additional $10 billion for Emergency Injury Disaster Loan Grants. Public Health and Social Services Emergency Fund Phase 3.5 provides an additional $75 billion to the Public Health and Social Services Emergency Fund for hospitals and other health care providers to prevent, prepare for, and respond to coronavirus. This fund is managed by the Department of Health and Human Services. The CARES Act originally appropriated $100 billion to this fund, $30 billion of which was distributed beginning on April 10, 2020 with payments arriving in eligible health care providers’ bank accounts via direct deposit. On April 22, 2020, HHS unveiled the next phase of these distributions through a series of general and targeted distributions aimed in part at providing relief to those providers in areas highly impacted by COVID-19. Funds Allocated for Testing Phase 3.5 also provides $25 billion to the Public Health and Social Services Emergency Fund specifically for expenses surrounding the research, development, validation, manufacture, purchase, administration, and expanding of capacities for COVID-19 testing. A breakdown of the allocations for testing in Phase 3.5 is below: • $11 billion of these funds have been allocated to states to develop, purchase, administer, process, and analyze COVID-19 tests, including support for workforce, epidemiology, use by employers, scale up testing by public health and hospital laboratories, and community-based testing sites, health care facilities, and other entities engaged in testing. • $2 billion is to be provided to the states based on the Public Health Emergency Preparedness cooperative agreement in FY 2019; • $4.25 billion is to be allocated based on the number of COVID-19 cases; and • $750 million is to be provided to the Indian Health Service to aid tribes, tribal organizations, and Indian Health Service facilities. • $1 billion to the CDC for surveillance, epidemiology, laboratory capacity expansion, contact tracing, public health data surveillance and analytics infrastructure modernization, disseminating information about testing, and workforce support. • $1 billion to the NIH to develop, validate, improve, and implement testing and associated technologies and to accelerate research, development, and implementation of point of care and other rapid testing. • $1 billion to the Biomedical Advanced Research and Development Authority to cover research expenses. • $22 million to the FDA to support activities associated with diagnostic, serological, antigen, and other testing. • $600 million to HRSA for grants under the Health Centers program. • $225 million to rural health clinics to provide COVID-19 testing, with such funds also available to RHCs for building or construction of temporary structures, leasing of properties, and retrofitting facilities as necessary to support COVID-19 testing. • $1 billion for covering the costs of testing the uninsured. We are keeping a close eye on the rapid developments surrounding COVID-19. If you have any questions about this latest guidance issued by HHS, the CARES Act, or any questions related to COVID-19, please contact the author of this blog or contact your Dorsey and Whitney LLP attorney. You can access Dorsey’s coronavirus resource center, which contains a wide variety of legal resources related to the coronavirus outbreak, available here. You can also access Dorsey’s health law blog related to health law updates, including those applicable to tax exempt entities in the health care space, available here.

On April 22, 2020, the Department of Health and Human Services (“HHS”) issued a press release outlining the allocation of an additional $70 billion dollars in appropriations allocated by the CARES Act to the Public Health and Social Services Emergency Fund.  The initial $30B tranche of the total $100 billion provided for under the CARES Act was distributed earlier this month to providers based on a methodology taking into account those providers’ Medicare receipts from the prior year.  This is the “second round” of the initial funding provided for under the CARES Act and includes both a “General Allocation” of $50 billion and smaller “Targeted Allocations.”   In allocating the funds, HHS stated they are “working to address both the economic harm across the entire healthcare system due to the stoppage of elective procedures, and addressing the economic impact on providers incurring additional expenses caring for COVID-19 patients, and to do so as quickly and transparently as possible.” On April 21, 2020, the U.S. Senate passed a bill, colloquially referred to as “Stimulus Phase 3.5,” which provides for an additional $75 billion to replenish the Public Health and Social Services Emergency Fund.  These latest allocations are not related to the potential Stimulus 3.5 funds.  We are continuing to monitor Stimulus 3.5 funds and will update our website once that next round of stimulus funding is approved by the President.    The guidance provided by HHS with respect to the latest allocation of the additional $70 billion in appropriations for providers is below. I. GENERAL ALLOCATION $50 billion of the Provider Relief Fund is allocated for general distribution to Medicare facilities and providers impacted by COVID-19, based on eligible providers' 2018 net patient revenue.  To expedite providers getting money as quickly as possible, $30 billion was distributed immediately, proportionate to providers' share of Medicare fee-for- service reimbursements in 2019. On Friday, April 10, $26 billion was delivered to bank accounts. The remaining $4 billion of the expedited $30 billion distribution was sent on April 17. HHS said they used this formula to get the money out the door as quickly as possible.  HHS stated that, beginning this week, they will begin distribution of the remaining $20 billion of the general distribution to these providers to augment their allocation so that the whole $50 billion general distribution is allocated proportional to providers' share of 2018 net patient revenue. On April 24, a portion of providers will automatically be sent an advance payment based off the revenue data they submit in CMS cost reports. Providers without adequate cost report data on file will need to submit their revenue information to a portal opening this week at https://www.hhs.gov/providerrelief for additional general distribution funds.  Providers who receive their money automatically will still need to submit their revenue information so that it can be verified. Payments will go out weekly, on a rolling basis, as information is validated, with the first wave being delivered at the end of this week (April 24, 2020). Providers who receive funds from the general distribution have to sign an attestation confirming receipt of funds and agree to the terms and conditions of payment and confirm the CMS cost report. The terms and conditions also include other measures to help prevent fraud and misuse of the funds. All recipients will be required to submit documents sufficient to ensure that these funds were used for healthcare-related expenses or lost revenue attributable to coronavirus. HHS warned that there will be significant anti-fraud and auditing work done by HHS, including the work of the Office of the Inspector General. In the latest allocation, HHS reinforced President Trump’s directive that as a condition to receiving these funds, providers must agree not to seek collection of out-of-pocket payments from a presumptive or actual COVID-19 patient that are greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network provider. II. TARGETED ALLOCATIONS A. ALLOCATION FOR COVID-19 HIGH IMPACT AREAS $10 billion will be allocated for a targeted distribution to hospitals in areas that have been particularly impacted by the COVID-19 outbreak. As an example, HHS said that hospitals serving COVID-19 patients in New York, which has a high percentage of total confirmed COVID-19 cases, are expected to receive a large share of the funds.  Hospitals should apply for a portion of the funds by providing four simple pieces of information via an authentication portal before midnight PT, Thursday April 23. This portal is live, and hospitals have already been contacted directly to provide this information. Hospitals will need to provide:  Tax Identification Number National Provider Identifier Total number of Intensive Care Unit beds as of April 10, 2020 Total number of admissions with a positive diagnosis for COVID-19 from January 1, 2020 to April 10, 2020 HHS stated that the authentication and data-sharing process should take less than five minutes via a system that should be familiar to most hospitals. HHS indicated this information is necessary for the government to determine what facilities will qualify for a targeted distribution. They added that supplying this information does not guarantee receipt of funds from this distribution. HHS will use the data it receives to distribute the targeted funds to where the impact from COVID-19 is greatest. The distribution will take into consideration the challenges faced by facilities serving a significantly disproportionate number of low-income patients, as reflected by their Medicare Disproportionate Share Hospital (DSH) Adjustment. B. ALLOCATION FOR TREATMENT OF THE UNINSURED As announced in early April, a portion of the $100 billion Provider Relief Fund will be used to reimburse healthcare providers, at Medicare rates, for COVID-related treatment of the uninsured. Every health care provider who has provided treatment for uninsured COVID-19 patients on or after February 4, 2020, can request claims reimbursement through the program and will be reimbursed at Medicare rates, subject to available funding. Steps will involve: enrolling as a provider participant, checking patient eligibility and benefits, submitting patient information, submitting claims, and receiving payment via direct deposit. Providers can register for the program on April 27, 2020, and begin submitting claims in early May 2020. For more information, visit coviduninsuredclaim.hrsa.gov. C. ALLOCATION FOR RURAL PROVIDERS $10 billion will be allocated for rural health clinics and hospitals.  This money will be distributed as early as next week (April 27, 2020) on the basis of operating expenses, using a methodology that distributes payments proportionately to each facility and clinic. This method recognizes the precarious financial position of many rural hospitals, a significant number of which are unprofitable. Rural hospitals are more financially exposed to significant declines in revenue or increases in expenses related to COVID-19 than their urban counterparts. D. ALLOCATION FOR INDIAN HEALTH SERVICE Included in the allocation is $400 million which will be allocated for Indian Health Service (“IHS”) facilities, distributed on the basis of operating expenses. Indian Country is also being impacted by COVID-19.  This money will be distributed as early as next week (April 27, 2020) on the basis of operating expenses for facilities. HHS indicated that this serves as a complement for “other funding provided to IHS and work we've done to expand IHS capacity for telehealth.” E. ADDITIONAL ALLOCATIONS HHS indicated that there are some providers who will receive further, separate funding, including skilled nursing facilities, dentists, and providers that solely take Medicaid. F. HELPING ENSURE ALL AMERICANS HAVE ACCESS TO CARE The Families First Coronavirus Response Act, as amended by the CARES Act, requires private insurers to waive an insurance plan member's cost-sharing payments for COVID-19 testing. The President also secured funding to cover COVID-19 testing for uninsured Americans. The Trump Administration has also touted secured commitments from private insurers, including Humana, Cigna, UnitedHealth Group, and the Blue Cross Blue Shield system, to waive cost-sharing payments for treatment related to COVID-19 for plan members. As a condition to receiving general funds, providers must agree not to seek collection of out-of-pocket payments from a presumptive or actual COVID-19 patient that are greater than what the patient would have otherwise been required to pay if the care had been provided by an in-network provider. We are keeping a close eye on the rapid developments surrounding COVID-19.  If you have any questions about this latest guidance issued by HHS, the CARES Act, or any questions related to COVID-19, please contact the authors of this blog or contact your Dorsey and Whitney LLP attorney. You can access Dorsey’s coronavirus resource center, which contains a wide variety of legal resources related to the coronavirus outbreak, available here. You can also access Dorsey’s health law blog related to health law updates, including those applicable to tax exempt entities in the health care space, available here. 

The recently-enacted Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) is generally known for providing relief funds and other resources to help individuals, small businesses, state and local governments, and hospitals and healthcare providers address the COVID-19 public health emergency.  However, among the lesser-known of the CARES Act provisions are changes to federal law that will allow a significant harmonization of rules governing the confidentiality of substance use disorder patient records with the general federal rules governing the privacy of individually identifiable health information (i.e., the HIPAA privacy rules). Currently, a unique set of federal regulations found at 42 C.F.R. Part 2 restrict the disclosure and use of substance use disorder patient records that are maintained in connection with any federally-assisted substance use disorder program.  These “Part 2” rules are far stricter than the federal HIPAA privacy rules that apply generally to health plans and health care providers.  For example, whereas the HIPAA privacy rules allow health plans and health care providers to use and disclose protected health information (“PHI”) for purposes of treatment, payment, and health care operations without a patient’s written or oral consent, the Part 2 rules do not.  Another important distinction between the Part 2 rules and HIPAA is that if a patient authorizes the disclosure of PHI under HIPAA to an entity that is not regulated by HIPAA, then the PHI disclosed to that recipient falls outside the protections of HIPAA.  In contrast, when a patient consents to the disclosure of their substance use disorder records under Part 2, the Part 2 rules continue to apply to the records disclosed, even when the recipient is not a regulated Part 2 SUD program. Section 3221 of the CARES Act modifies the statute governing the confidentiality of SUD records in various and important ways.  First, a Part 2 SUD program will be allowed to obtain the prior written consent of a patient to use and disclose SUD records for purposes of treatment, payment, and health care operations as permitted by the HIPAA privacy rules.  An SUD program will need to obtain that patient consent only once, and the consent will apply to all future uses and disclosures of SUD records until a patient revokes the consent in writing. The statute goes on to state that any information disclosed pursuant to such a consent may then be redisclosed in accordance with the HIPAA regulations.   Although not entirely clear, this appears to mean that an entity not regulated by HIPAA that receives SUD records pursuant to a consent may redisclose the records without limitation under either HIPAA or the Part 2 rules. The CARES Act also states explicitly that the HIPAA breach notification provisions apply to SUD records held by a Part 2 program in the same manner that those rules apply to HIPAA covered entities. Furthermore, the CARES Act extends HIPAA’s penalty and enforcement provisions to violations of the Part 2 rules.  Although the Department of Health and Human Services (“HHS”) will need to issue regulations to confirm the operation of these enforcement provisions, this appears to mean that the HHS Office for Civil Rights may take on the civil enforcement of the Part 2 rules, in addition to enforcing the HIPAA rules. The primary reason for the historically strict privacy rules applicable to SUD records is to ensure that a patient receiving treatment for a substance use disorder in a Part 2 program is not more vulnerable because of the availability of their patient record than an individual with a substance use disorder who does not seek treatment.  In an effort to maintain this public policy goal while at the same time making the Part 2 rules more consistent with the HIPAA rules, the CARES Act enacts a general antidiscrimination provision prohibiting any entity from discriminating against an individual on the basis of information in Part 2 SUD records in: (a) admission, access to, or treatment for health care; (b) hiring, firing, or terms of employment or receipt of worker’s compensation; (c) the sale, rental, or continued rental of housing; (d) access to federal, state, or local courts; or (e) access to, approval of, or maintenance of government social services and benefits. Furthermore, other than as authorized by a court order or consented to by the patient, no SUD records or testimony relaying the information contained in such records, may be disclosed or used in any civil, criminal, administrative, or legislative proceedings conducted by any governmental authority against a patient. The statute mandates that regulations to implement and enforce these CARES Act provisions be issued to facilitate their application to all uses and disclosure of SUD records occurring on or after one (1) year following the enactment of the CARES Act (which would be March 27th, 2021).   Once implemented, the CARES Act provisions will be helpful to Part 2 programs, many of which struggle with the complexity of complying with both HIPAA and the Part 2 privacy rules.  But the new Part 2 law will by no means alleviate all of that complexity.  For example, a Part 2 program will be required to obtain a patient’s written consent in order to use and disclose SUD records for treatment, payment, and health care operations purposes; for those Part 2 program patients that refuse to sign such a consent, the Part 2 program will likely need to segregate those SUD records in order to manage the stricter limitations on their use and disclosure.  Moreover, the CARES Act does not harmonize Part 2 and HIPAA entirely; there will remain many uses and disclosures that are permitted under HIPAA but not permitted with regard to SUD records under Part 2.  Ultimately the CARES Act provisions modifying the Part 2 confidentiality rules will mitigate, but not eliminate, the complexities of managing patient records regulated by two separate sets of federal privacy rules. If you have questions about the CARES Act, HIPAA, or the Part 2 rules, please contact the author or any attorney in the Dorsey & Whitney health transactions and regulations practice group.