Dorsey Health Law
False Claims Act
DOJ Secures FCA Settlement with Health Services Companies
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 U.S. Attorney’s Office for the District of Massachusetts recently secured a settlement agreement resolving allegations that Molina Healthcare, Inc. and its prior subsidiary, Pathways of Massachusetts, which provide mental health services in Springfield and Worcester, Massachusetts, violated the False Claims Act (“FCA”), 31 U.S.C. § 3729 et seq. and the Massachusetts-equivalent to the FCA. The settlement agreement also resolves similar claims brought by employees of Molina Healthcare and Pathways under the qui tam provisions of these statutes. Under the terms of the settlement agreement, Molina Healthcare and Pathways have agreed to pay the federal government and Massachusetts $4,625,000 to resolve these claims. Read more here.
July 18, 2022
False Claims Act
DOJ Announces Settlement with Home-Health Services Company Over FCA Kickback and Overbilling Allegations
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 Tess Erickson for the following post on the FCA Now blog: The Department of Justice recently announced that it resolved two civil lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act to the tune of nearly $4 million. The suits alleged that a suburban Chicago diagnostics company, SNAP Diagnostics, LLC, that provides home testing for sleep disorders was defrauding Medicare and four other federal health care programs through kickbacks and unnecessary testing. Since Medicare began covering home sleep testing in 2009, SNAP has received nearly $9 million from Medicare – almost all of it the result of fraud and kickbacks, according to the government’s allegations. Read more here.
June 20, 2022
Employment
New Iowa Law Will Impact Health Care Staffing Agencies and Contracts with Health Care Entities
On March 17, 2022, Iowa Governor Kim Reynolds signed into law House File 2521, “Relating to Health Care Employment Agencies, and Providing Penalties,” which will have its home in Chapter 135Q of the Iowa Code. In general, the law does three things. One, it requires health care employment agencies to annually register with the state Department of Inspections and Appeals (DIA) and pay a $500 registration fee. Two, it details recordkeeping and other requirements related to agency employees, and prohibits the inclusion of certain terms in contracts with health care entities. Three, it imposes penalties for non-compliance. The law broadly defines a “health care employment agency” as “an agency that contracts with a health care entity in this state to provide agency workers for temporary, temporary-to-hire, direct hire, or other contract or employee placements.” Similarly, a “health care entity” is defined as “a licensed or certified facility, organization, or agency operated to provide services and supports to meet the health or personal care needs of consumers.” Under the new law, health care employment agencies must do the following: Register each location of the health care employment agency on an annual basis with DIA, and pay a $500 registration fee; Ensure that agency workers comply with all applicable requirements relating to the health requirements and qualifications of personnel in health care entity settings (i.e. licensing, certification, training, and health requirements and continuing education standards), and document that agency workers meet these requirements; Maintain records for each agency worker and report, file, or otherwise provide any required documentation to external parties or regulators which would otherwise be the responsibility of the health care entity if the agency worker worked directly for the health care entity; Maintain professional and general liability insurance coverage with minimum per occurrence coverage of $1 million and aggregate coverage of $3 million to insure against loss, damage, or expense incident to a claim arising out of death or injury as the result of negligence or malpractice by health care employment agency or agency worker; and Submit quarterly financial reports to DIA regarding amounts charged to health care entities. As previously discussed, the CMS Interim Final Rule requiring staff vaccination against COVID-19 extends to agency employees not directly employed by Medicare or Medicaid providers and suppliers (“Covered Healthcare Employers”). House File 2521 appears to codify such a vaccination requirement in mandating that health care employment agencies ensure that agency workers comply with all applicable requirements relating to the health requirements of personnel in health care entity and documenting that compliance. Also under the new law, health care employment agencies are prohibited from placing any restrictions on “employment opportunities of an agency worker by including a non-compete clause in any contract with an agency worker or health care entity.” In addition, contracts between agencies and health care entities may not “require payment of liquidated damages, employment fees, or other compensation if the agency worker is subsequently hired as a permanent employee of the health care entity.” In other words, health care employment agencies may not require their employees to sign non-compete agreements as a condition of employment, and health care employment agencies may not require health care entities to pay any kind of “finder’s fee” for directly hiring an agency employee. Any contracts that violate new Iowa Code Chapter 135Q are unenforceable. Several questions remained immediately after Governor Reynolds signed House File 2521, particularly regarding its scope of coverage. On May 24, 2022, the Iowa legislature attempted to address one of those questions in House File 2589 by clarifying that Iowa Code Chapter 135Q applies retroactively to any contracts entered into on or after January 1, 2019. While Governor Reynolds is yet to sign House File 2589, her signature is expected. From a legal standpoint, we likely have not heard the last of Iowa Code Chapter 135Q and House File 2589. The DIA is tasked with implementing administrative rules to carry out the new law, and those rules may provide further clarification regarding scope of coverage, grace periods for penalties, and other clarifications. For now, Iowa Code Chapter 135Q becomes effective July 1, 2022. At that point, any contracts between health care employment agencies and health care entities, entered into on or after January 1, 2019, that contain any of the prohibited provisions described above, are unenforceable. From a practical standpoint, that means health care entities should renegotiate their contracts with health care employment agencies. We recommend that in addition to ensuring compliance with Iowa Code Chapter 135Q, health care entities should ensure that the re-negotiated contracts include language requiring agency compliance with the CMS Interim Final Rule requiring staff vaccination against COVID-19.
June 10, 2022
COVID-19
Healthcare Fraud Settlement Showcases Government’s Additional Focus on COVID-19-Related Fraud
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.
June 1, 2022
False Claims Act
More DOJ Double-Dipping PPP Fraud News
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”) continues rolling out new settlement agreements related to COVID-19 fraud—highlighting the government’s and a common relator’s efforts to crack down on those alleged to have improperly received monies through the Paycheck Protection Program (“PPP” or “Program”). A new settlement agreement once again showcases these trends and illustrates the civil liability that businesses and individuals may face under the False Claims Act, 31 U.S.C. § 3729 et seq (“FCA”) for double-dipping into PPP loan funds made available in 2020 during the height of the pandemic. Read more here.
May 23, 2022
Long Term Care
Minnesota’s New Assisted Living License Renewal Process Clarified
As readers of this blog know from prior posts linked here and here, Minnesota instituted new licensure categories for assisted living facilities last year. Those initial one-year licenses were granted by the Minnesota Department of Health (“MDH”) on August 1, 2021. On May 1, 2022, the process to renew those initial licenses began. Here are some important points for Minnesota assisted living licensees to be aware of. Renewal Timeline MDH sent notices to assisted living licensees at the end of April informing them that renewal applications are due by June 1. MDH will consider applications received after June 1 to be late, however there is a one month grace period and MDH will not begin to impose a late filing penalty of $200 until applications are filed after July 1. Applications filed after August 1 will incur a fine of $250 per day until the license is issued. Furthermore, the current license will be considered expired as of August 1 and it is a misdemeanor to provide assisted living services without a license. See Minn. Stat. 144G.12, Subd. 4. Renewed Licenses When issuing renewed licenses on August 1, 2022, MDH will randomly assign a 5 to 16 month renewal period for a licensee’s first renewal and by so doing will establish a staggering of subsequent renewals. Thereafter, each renewal will be for a 12 month period. So for example, on the shortest end of the range a renewed license will be issued on August 1, 2022 and will expire on December 31, 2022, and on the longest end of the range a renewed license will not expire until November 30, 2023. In each case, the next renewal following expiration will be for a 12 month period to establish the staggering mentioned above. MDH is offering certain licensees the option to request a different renewal period than one randomly assigned. Licensees with more than one assisted living facility license have the option to request all license renewal dates occur in different months, throughout a 12-month period. If no such request is made, the default will be that all of such licensee’s licenses will be scheduled to renew in the same month. Licensees also have the option to request a change to the randomly assigned renewal period based on financial hardship. Both types of requests must be submitted on MDH’s forms for such requests by June 1, 2022. It is important to note that the license renewal process may not be used to change the category of license a facility has. As a reminder, Minnesota implemented two categories of licenses – an assisted living facility license and an assisted living facility with dementia care license. A facility’s license category may not be changed through the renewal process, which is only for renewing the same category of license. License renewal fees vary by license category and will be prorated for a renewal period of less or more than one year. The 12-month assisted living facility license renewal fee is $2,000 plus $75 per licensed resident capacity, and the 12-month assisted living facility with dementia care license renewal fee is $3,000 plus $100 per licensed resident capacity. Finally, if a licensee does not intend to renew its license, then the licensee must complete and submit MDH’s closure form and closure plan for MDH approval per Minn. Stat. 144G.57 prior to June 1, 2022. If you have questions about Minnesota’s assisted living license renewal process, please contact the author or your regular Dorsey attorney.
May 5, 2022
False Claims Act
Latest PPP Fraud Settlement Showcases Civil and Criminal Penalties for Knowingly Submitting False Claims
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”) continues racking up more settlement agreements under the False Claims Act, 31 U.S.C. § 3729 et seq (“FCA”) with companies and individuals alleged to have improperly used funds received through the Paycheck Protection Program (“PPP” or “Program”). The latest PPP fraud settlement illustrates that attempts to fraudulently obtain forgiveness of PPP loans used for ineligible expenses invites potential liability under the FCA in addition to liability under its criminal counterpart, 18 U.S.C. § 287. Read the rest of the post here.
April 28, 2022
American Health Law Association 2022 Health Care Transaction Conference
After a 2-year hiatus, health care transactional attorneys and related industry professionals descended upon Nashville, TN April 25th – 27th for the 2022 American Health Law Association (“AHLA”) Health Care Transactions Conference. Aside from hot chicken and honky tonks, this conference was largely a celebration of the strength and resiliency of the health care industry during the past two COVID19-impacted years. Here are some of our main takeaways from the conference: Strong Transaction Activity: Health care-related deal value and volume has been at an all-time high, with evidence of continued growth. COVID19 increased federal and private health care funding and also highlighted various inefficiencies in the market. These factors have contributed to record transactional activity that takes advantage of the increased value and the opportunity to improve health care delivery in a post-COVID world. Industry experts do not expect this trend to slow down any time soon, especially with increased private equity and corporate investment in the space. Private Equity Leads the Charge: While not necessarily new to the world of health care transactions, private equity (“PE”) groups have taken a strong interest in increasing investment. PE groups view the health care space as a potentially untapped resource for short-term high rates of return. For the past 20 years, return on investment in health care transactions has largely edged out returns in all other industries. PE groups are not the only non-traditional players increasingly navigating health care transactions. Corporate investment from the likes of Walmart and Amazon continue to shift care delivery away from independent practice to a more corporate-backed model. Further, the growth of telehealth as a more accepted form of care delivery also makes the health care industry particularly inviting, considering what would traditionally be limited to local practice can now be expanded nationwide with relative ease. Of course, with increased corporate involvement comes increased scrutiny. Antitrust Overhaul: Federal and state enforcement of antitrust rules is on the rise. On July 9, 2021, President Biden issued an executive order urging the Federal Trade Commission (“FTC”) to bolster its antitrust review of health care transactions. The FTC is now actively reviewing its horizontal and vertical merger guidelines to determine whether such guidelines are too permissive. One of the items the FTC is considering is requiring that more information be provided on a pending transaction on a quicker timeline. Additionally, certain states (e.g., Nevada, Washington, Oregon, and Massachusetts) are beginning to implement their own pre-closing transaction notification requirements that would encompass a broader range of health care transactions (as compared to the current HSR filing threshold of $101 million). Stark and Anti-Kickback: Recent changes to the Stark and Anti-Kickback rules highlight that regulators may be starting to take a more business-oriented approach to framing acceptable compensation arrangements. This is mainly shown in the changes/clarifications made to language related to fair market value, commercially reasonable transactions, and the volume/value standard. For additional discussion of these rules, please see our previously published blog here. The 2022 AHLA Health Care Transactions Conference covered a lot of ground. If you have any questions on the topics covered, please do not hesitate to reach out to the author or your regular Dorsey attorney.
April 27, 2022
False Claims Act
DOJ Shows No Sign of Slowing Down Prosecution of Individuals Connected to FCA Cases
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 Katherine Chaves for the following post on the FCA Now blog: Following a record year for False Claims Act (“FCA”) settlements and judgments in 2021, the Department of Justice (”DOJ”) continues to aggressively pursue the prosecution of not only corporations, but also the individuals connected to corporate criminal cases. Within the first quarter of 2022, the DOJ has already announced numerous False Claims Act violations involving corporate defendants, including a $260 million settlement with pharmaceutical company Mallinckrod, a $48.5 million settlement with TriMark USA, LLC, and a $20 million settlement with BayCare Health System Inc. A notable theme emerging from the DOJ’s stream of FCA prosecution press releases, however, is its focus on holding individual defendants accountable for crimes committed in connection with their corporate activity. Read the rest of the article here.
April 27, 2022
Anti-Kickback
How EKRA and AKS Impact Laboratories and Commission-Based Compensation
With the enactment of the Eliminating Kickbacks in Recovery Act (“EKRA”) in 2018, the permissibility of commission-based compensation to laboratory sales representatives based on volume, revenue, or profit has come under question, and there is still little case law interpreting the Act. Despite EKRA being a relatively newer law, laboratories should remain mindful of how the more established Anti-Kickback Statute (the “AKS”) impacts the permissibility of such commission-based compensation as well. Under current law, commission-based payments (including commission based on volume, revenue, profit, etc.) should be permissible when paid to employee sales representatives. However, labs should be cautious when considering commission-based compensation to independent contractor sales representatives. I. The Anti-Kickback Statute The AKS subjects to criminal and civil penalties anyone who knowingly and willfully offers, pays, solicits, or receives remuneration to induce or reward the referral of business reimbursable under any federal health care programs. 42 U.S.C. § 1320a-7b(b). Importantly, the AKS extends beyond paying value in exchange for direct patient referrals; it also prohibits paying remuneration intended to induce or reward someone to arrange for or recommend that others purchase, lease, or order any good, facility, service, or item reimbursable by any federal health care program. See Id. The AKS contains numerous safe harbors, the compliance with which protects parties from violation of the AKS. One of these is the employment safe harbor, which permits any payments to an employee if there is a bona fide employment relationship. 42 U.S.C. § 1320a-7b(b)(3)(B). This safe harbor does not extend to independent contractors. Id. II. The Eliminating Kickbacks in Recovery Act EKRA subjects to criminal penalties anyone who, with respect to services covered by certain public health care benefit programs, knowingly and willfully: (1) solicits or receives any remuneration in return for referring a patient or patronage to a recovery home, clinical treatment facility, or laboratory; or (2) pays any remuneration to induce a referral of an individual to a recovery home, clinical treatment facility, or laboratory or in exchange for an individual using the services of that recovery home, clinical treatment facility, or laboratory. 18 U.S.C. § 220(a). Laboratory is defined to include all laboratories, not just those that perform testing related to substance abuse. 18 U.S.C. § 220(e)(4). Notably, EKRA’s language appears to be limited to paying for direct referrals. Unlike AKS, EKRA does not include language that extends its prohibitions to paying for arranging or recommending others to make referrals or order services. In addition, EKRA does not have an employee safe harbor analogous to the employee safe harbor under AKS, but rather has a narrower exception permitting payments made under a bona fide employment relationship (including with independent contractors, unlike under the AKS employment safe harbor) where the payment does not vary based on the procedures performed, or amounts billed or received from the health care benefit program from the individuals referred. 18 U.S.C. § 220(b)(2). In 2021, a federal district court in Hawaii issued the first and, to date, only judicial opinion interpreting EKRA in S&G Labs Haw., LLC v. Graves, 2021 U.S. Dist. LEXIS 200365. The district court held that while the employment agreement with Graves (a client account manager) provided for commission-based payments that varied based on the number of tests S&G performed, the arrangement did not violate EKRA since there was only an attenuated connection between the commission-based payments and patient referrals: “Undoubtedly, Graves’s commission-based compensation structure induced him to try to bring more business to S&G . . . However, the ‘client’ accounts they serviced were not individuals whose samples were tested at S&G. Their ‘clients’ were ‘the physicians, substance abuse counseling centers, or other organizations in need of having persons tested.’ However, S&G was not compensated by those ‘clients’; S&G was ‘compensated for the testing services on a ‘per test’ basis by third party insurers, government agencies under the Medicare and Medicaid programs, and direct self-pay by some individuals.’ There is no evidence that Graves’s client accounts included individuals who self-paid for S&G to perform urinalysis on their samples.” Id. at 33-34. The district court concluded that since “Graves was not working with individuals, the compensation that S&G paid him was not paid to induce him to refer individuals to S&G.” Id. at 34. In other words, the district court concluded that because Graves was not himself a source of lab referrals, EKRA’s prohibitions could not reach the volume-based compensation arrangement between Graves and his laboratory employer. III. Commissions to Employee Sales Representatives vs. Independent Contractor Sales Representatives Under current law discussed above, labs should generally be able to make commission-based payments (including commissions based on volume, revenue, profit, etc.) to employee sales representatives, but should carefully consider the AKS when proceeding with respect to independent contractor sales representatives. A. Employee Sales Representatives Commission-based payments, including commission based on volume, revenue, profit, etc., to employee sales representatives are permissible under the AKS. Such payments would fall within the AKS employment safe harbor so long as a bona fide employment relationship exists. Per the S&G Labs interpretation of EKRA, commission-based payments, including commission based on volume, revenue, profit, etc., to employee sales representatives are also permissible under EKRA, provided that a lab’s employee sales representatives have a similar relationship to their client accounts as that described in S&G Labs, wherein sales representatives are working with physician clinics, hospitals, and other organizations and facilities that would utilize the lab, and are not working with individual patients. B. Independent Contractor Sales Representatives Based on the only case law to address the issue at this point, so long as independent contractor sales representatives work with organizations and facilities, and are not in a position to refer individual patients, then EKRA should not bar commission-based payments to a lab’s independent contractor sales representatives. However, commission-based payments to independent contractor sales representatives remain an issue under the AKS if the laboratory business involves federal health care programs. Such payments fall outside of the employment safe harbor to the AKS, and the broad reach of the AKS prohibition on arranging or recommending that others order items and services could extend to payment arrangements with independent contractor sales representatives. Consequently, laboratories should proceed cautiously when considering compensating independent contractor sales personnel based in whole or in part on a volume- or value-based methodology. We will continue to closely monitor the state of EKRA and the AKS for guidance, revisions to the law, and enforcement. If you have further questions or need advice on how to restructure compensation arrangements to comply with EKRA and the AKS, please contact the authors or your regular Dorsey attorney.
April 15, 2022
False Claims Act
Home-Health Services Company Settles After Allegations of Double-Billing Scheme
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 Ryan Cole for the following post on the FCA Now blog: The Department of Justice recently announced that a home-health services company has agreed to pay over $45,000 to resolve alleged False Claims Act (“FCA”) violations. Professional Family Care Services, Inc. (“PFCS”), a North Carolina corporation, faced allegations of fraudulent billing for work by an employee that was convicted of wire fraud and sentenced to prison for her role in the alleged scheme. Read more here.
March 8, 2022
COVID-19
Covid-19 Requirements for Healthcare Employers: A Recap of Where Things Stand
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.
March 3, 2022
DOJ
DOJ Announces More FCA Settlement Agreements Over PPP Fraud
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: Fresh off the new year, the Department of Justice (“DOJ”) continues to announce new settlements under the False Claims Act, 31 U.S.C. § 3729 et seq (“FCA”)—further cementing the trend of private parties suing borrowers for violating requirements of the Paycheck Protection Program (“PPP” or the “Program”). Two new FCA settlements were announced earlier this month involving relators’ allegations that borrowers made false statements when applying for PPP loans in violation of Program rules. Read more here.
March 1, 2022
coronavirus
Employee Covid-19 Tests—When Must Employers Pay?
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 >
February 10, 2022
Increase in HSR Reportability Thresholds and Other HSR Developments
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 Michael Lindsay, Jamie Stilson, Anthony Badaracco and David Racine for the following e-newsletter update: Increase in HSR Reportability Thresholds and Other HSR Developments In January 2022, the Federal Trade Commission (FTC) made two important announcements for M&A practitioners. First, on January 24, the FTC announced the annual adjustment of the thresholds that trigger premerger reporting obligations under the Hart-Scott-Rodino (HSR) Act. The new thresholds will apply to transactions closing after February 23, 2022. Second, the FTC announced the annual adjustment for maximum daily civil penalties for noncompliance with the HSR Act’s requirements (failure to file, failure to observe the mandatory waiting period, or failure to make a complete filing). This article summarizes the HSR Act’s requirements and reports on several relevant developments in 2021. On January 24, the FTC also announced adjusted thresholds that trigger prohibitions on certain interlocking memberships on corporate boards of directors. These new thresholds became effective immediately on publication in the Federal Register. Both these and the HSR Act thresholds will remain in effect until the 2023 adjustments. (Read the rest of the article here.)
January 25, 2022
COVID-19
U.S. Supreme Court Lifts Injunction Against CMS’ Health Care Facility Vaccine Mandate: What Does This Mean for Your Health Care Facility?
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.
January 17, 2022
Anti-Kickback
HHS OIG Releases an Updated Health Care Fraud Self-Disclosure Protocol
On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a revised Provider Self-Disclosure Protocol, renamed Health Care Fraud Self-Disclosure Protocol (“SDP”). Prior to this update, the SDP had not been updated since 2013. While many of the revisions were procedural only, some of the revisions were notable, including an increase in the minimum amount required to settle fraud claims under the SDP. Background. The SDP was established in 1998 as a mechanism for health care providers, suppliers and other persons subject to the OIG’s civil monetary penalty (“CMP”) authorities to voluntarily disclose self-discovered evidence of possible fraud implicating federal health care program funds. Benefits of the SDP include potentially minimizing costs and disruptions for the disclosing party by avoiding a government-initiated investigation and accompanying litigation, paying a lower multiplier on damages than would be required in a government-initiated investigation, and a release from the OIG’s permissive exclusion authorities without integrity agreement obligations. The OIG has a website related to the SDP with additional information, including a list of recently settled SDP submissions. The OIG reported in the revised SDP that, between 1998 and 2020, it resolved over 2,200 disclosures, resulting in recoveries of more than $870 million to the federal health care programs. Certain conduct is not eligible for the SDP, such as disclosure of an arrangement that involves only liability under the federal physician self-referral law (or “Stark Law”) without also involving potential liability under the federal anti-kickback statute (“AKS”). The CMS Self-Referral Disclosure Protocol (“SRDP”) is available for conduct that involves only liability under the Stark Law. Updates. The most important update in the revised SDP is that the OIG increased the minimum amount required to settle fraud claims under the SDP in conformity with 2018 changes to statutory minimum penalty amounts for CMPs. The new minimum settlement amounts are $100,000 for kickback-related SDP submissions (up from $50,000) and $20,000 for all other SDP submissions (up from $10,000). In addition, all SDP submissions must now be made through OIG’s website (rather than either by mail or through the website), an SDP submission must disclose whether the disclosing party is subject to a Corporate Integrity Agreement, Corporate Integrity Agreement reportable events can be disclosed through the SDP, and an SDP submission must separately list damages to each impacted federal healthcare program as well as total damages. Next, the OIG clarified that the Department of Justice may participate in the settlement of a matter disclosed through the SDP and resolve it under the False Claims Act. The OIG also clarified that grant- or government contract-related disclosures should be done through the OIG’s Grant Self-Disclosure Program or Contractor Self-Disclosure Program, respectively, not the Health Care Fraud SDP. Finally, the OIG made several miscellaneous changes to statistics, terminology, and background information. Many of the core requirements for SDP submissions have not changed, however, such as timing and content requirements and damages calculation methodologies. In addition, the potential benefits of SDP submissions have not changed, including a potential exclusion release and lower multiplier for damages calculations. If you have any questions about the SDP or a potential disclosure through the SDP, please contact the authors or your regular Dorsey attorney.
November 29, 2021
Centers for Medicare and Medicaid Services
Limited Preliminary Injunction Issued for 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.
November 29, 2021
CMS Guidance
CMS’ COVID-19 Vaccine Mandate: What Health Care Providers and Suppliers Need to Know
**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.
November 9, 2021
False Claims Act
Enforcement Standards Tighten on Private Insurers: Sutter Health Settles for $90 Million Following Dispute With DOJ
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 Samuel Audley for the following FCA Now blog post: On August 30, 2021, the Department of Justice (“DOJ”) announced that Sutter Health and several of its affiliated entities (“Sutter”) agreed to pay a total of $90 million to settle allegations that Sutter violated the False Claims Act (“FCA”), 31 U.S.C. §§ 3729-3733, by “knowingly submitting inaccurate information about the health status of beneficiaries enrolled in Medicare Advantage Plans.” Read more here.
November 5, 2021
coronavirus
Additional EEOC Guidance for Employers Processing Religious Exemption Requests in Workplace COVID-19 Vaccine Mandates
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.
October 28, 2021
Long Term Care
New Minnesota Assisted Living Licensure Requirements Have Gone Into Effect and the First Survey Results Are Out
On August 1, 2021, an overhaul of the licensing requirements for Minnesota assisted living facilities (codified at Minn. Stat. 144G.08-9999) went into effect. Under the new law, which was also discussed in a previous Dorsey Health Law Blog post, Minnesota assisted living facilities are now required to obtain either an assisted living facility license or, for those that also provide dementia care services to any residents, an assisted living facility with dementia care license. The licensure scheme ushers in many new requirements aimed at protecting consumers, and the Minnesota Department of Health (“Department of Health” or “Department”) surveys facilities to ensure compliance. On August 15, 2021, the Department of Health began surveying the state’s 1,973 licensed assisted living facilities and on October 11, 2021, the Department released a report on the primary violations of the new requirements discovered in the first 17 facilities surveyed. The primary violations fall into three main categories: (1) failure to provide required disclosures, (2) failure to comply with fire safety requirements, and (3) failure to comply with internal systems requirements. Required disclosures A facility must display its license at the main public entrance of each building on its campus. A facility must provide all residents with the Assisted Living Bill of Rights (available on the Department of Health’s website) in addition to the facility’s Uniform Disclosure of Assisted Living Services & Amenities (UDALSA), which was completed by facilities as a component of the license application. The UDALSA must be provided to prospective residents prior to signing any contract and an updated UDALSA must be provided to residents and the Department of Health when services and amenities offered at the facility change. Facilities should also ensure they are in compliance with other miscellaneous notice requirements set forth in Minn. Stat. 144G.90. Fire safety Facilities must have an interconnected smoke alarm system with one alarm in each sleeping room and outside each separate sleeping room. If a facility is not fully outfitted with sprinklers, there must be smoke alarms on each story of a dwelling, including basements. A facility must have enough portable fire extinguishers such that the nearest one is within a 75 foot distance. Internal systems requirements Facilities must have in place certain required policies, including but not limited to those set forth in Minn. Stat. 144G.41. Facilities must comply with the contract requirements set forth in Minn. Stat. 144G.50. Facilities must comply with the statutory scheme’s electronic charting requirements. A facility’s clinical nurse supervisor must develop the facility’s staffing plan and the facility must post a daily staffing schedule. Finally, facilities must have an emergency plan in place that complies with Minn. Stat. 144G.42 and Rule 4659.0100. The Department of Health has publicly posted all of the forms it uses to survey assisted living facilities, and providers should take advantage of these resources to conduct a self-audit. Providers should ensure compliance in order to have a successful survey and avoid fines or other penalties, as described in Minn. Stat. 144G.31. If you have further questions about this new law, please contact the authors or your regular Dorsey attorney.
October 15, 2021
Stark
Stark Regulatory Changes Require Modifying Certain Group Practice Compensation Methodologies by January 1, 2022
There are now less than three months until changes to the federal physician self-referral law (“Stark Law” or “Stark”) group practice definition special compensation rule go into effect on January 1, 2022. As we wrote about here, these changes include revisions to the rule related to overall profits to prohibit pooling and distributing profits from designated health services (“DHS”) on a service-by-service basis, which is sometimes referred to as “split pooling.” As of that date, profits from all the DHS of the practice, or a component of the practice that consists of at least five physicians (a “5+ physician pod”), must be aggregated before distribution. Group practices that use split pooling need to modify their compensation methodologies to account for this change by January 1. Because of the time and effort involved in modifying physician compensation methodologies, now is the time for physician practices to evaluate whether any modifications to their compensation methodologies are needed in order to comply with this change. For a detailed summary of the Stark regulatory changes and their implications, please see the article we wrote earlier this year available here.
October 11, 2021
Employment
FAR Council Issues Guidance to Federal Contractors and Subcontracts Related to Mandatory Vaccination of Certain Employees
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 Ryan Mick, Katie Ervin Carlson and Andrew James for the following e-newsletter update: On September 30, 2021, the Federal Acquisition Regulation (“FAR”) Council issued a memorandum requiring that most federal contractors and subcontractors include a clause in future contracts and subcontracts that require employees to be vaccinated. This directive follows President Biden’s September 9 announcement, as well as the Safer Federal Workforce Task Force Guidance (the “Guidance”) issued on September 24. Read more here.
October 7, 2021
COVID-19
Updates on Legal Challenges to Health Care Employers’ Voluntary COVID-19 Vaccine Mandates
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.
September 28, 2021
coronavirus
Biden Administration Announces Broad Employer-Based Vaccination Requirements
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.
September 13, 2021
Centers for Medicare and Medicaid Services
CMS Advisory Opinion Approves Parent and Wholly-Owned Subsidiary Qualifying as “Single Legal Entity” under the Stark “Group Practice” Definition
The Centers for Medicare & Medicaid Services (“CMS”) released Advisory Opinion No. CMS-AO-2021-01 in June 2021, which gave the requestor the green light to provide designated health services (“DHS”) through wholly-owned subsidiaries while the parent and subsidiaries could qualify as a “single legal entity” under the “group practice” definition of the federal physician self-referral law (or “Stark Law”). As a result, the requestor is eligible for the in-office ancillary services (“IOAS”) exception to the Stark Law. This opinion is notable because CMS issues advisory opinions infrequently and, particularly given recent changes to the CMS advisory opinion regulations (as we wrote about here), other entities may use this opinion as guidance in forming similar arrangements. As background, under the IOAS exception, a physician practice may make referrals for DHS within the practice, but only if it qualifies as a group practice. The term “group practice,” defined in the Stark regulations, requires, among other things, that the practice is a “single legal entity” that operates “primarily for the purpose of being a physician group practice.” Accordingly, a “single legal entity” does not include physicians who are only informally affiliated for the purpose of sharing profits from referrals, but a single legal entity may itself own subsidiary entities. The recent advisory opinion focuses on whether a physician practice with wholly-owned subsidiary physician practices qualifies as a “single legal entity” for the purposes of the IOAS exception. The Advisory Opinion In short, the advisory opinion allows for a group practice with wholly-owned subsidiaries to provide services through those subsidiaries, even if the subsidiaries do not themselves qualify as group practice. The group practice and the subsidiaries, for purposes of the IOAS exception, qualify as a single legal entity. The Arrangement The requestor (“Group Practice”), was the sole owner of two subsidiary physician practices (the “Subsidiaries”). Group Practice was looking to provide services, including DHS, to patients, both directly and through the Subsidiaries. Group Practice attested that, while the Subsidiaries would retain their own Medicare enrollment and use billing numbers assigned to them to bill Medicare for items and services they furnish to beneficiaries, the material assets and business functions of the Subsidiaries would be transferred to Group Practice or the practice’s management company. The management company would provide non-clinical services to both Group Practice and the Subsidiaries. The revenue and expenses of the Subsidiaries would be attributed to Group Practice. Furthermore, the clinical employees and contractors of the Subsidiaries would become employees and contractors of Group Practice, and the patients served by the Subsidiaries would be considered patients of Group Practice. Group Practice certified that it met all requirements of a group practice itself and that the arrangement with the Subsidiaries would meet all other requirements of a group practice, such as having centralized decision-making. The Subsidiaries did not qualify as group practices on their own, and Group Practice specifically sought to determine if it, in its arrangement with the Subsidiaries, could qualify as a “single legal entity” for the purposes of the group practice definition, thus meeting this requirement of the IOAS exception. CMS Analysis CMS found that Group Practice and the Subsidiaries would qualify as a single legal entity. In concluding this, CMS focused heavily on two aspects of the relationship: (1) the revenue and expenses of the Subsidiaries would be attributed to Group Practice, and (2) the clinical employees and contractors of the Subsidiaries would become employees and contractors of Group Practice. CMS found the first factor to be adequate even though the Subsidiaries maintained their own Medicare enrollments and payor contracts separate from Group Practice. What This Means for Physician Practices Reliance on Advisory Opinions On January 1, 2020, the Stark regulations regarding advisory opinions were revised. Prior to this revision, only the entity requesting the advisory opinion and others who were parties to the specific arrangement could rely on the opinion. Under the revised advisory opinion regulations, the Secretary of HHS will not pursue sanctions against other entities who did not make the request for the opinion and who are not parties to the specific arrangement, as long as their arrangement is ”indistinguishable in all its material aspects” from an arrangement which received a favorable advisory opinion from CMS. See our detailed analysis of the revised advisory opinion regulations here. This means that other physician practices outside of Group Practice and the Subsidiaries can make referrals to wholly-owned subsidiaries if such arrangements are indistinguishable in all material aspects from the one described in the opinion and otherwise meet the requirements of the group practice definition and IOAS exception. Below is a brief list and description of factors that would likely be considered material to this arrangement, and thus necessary for physician practices seeking to rely on Advisory Opinion No. CMS-AO-2021-01. Referrals to Subsidiaries Parent-Subsidiary Relationship The parent-subsidiary relationship is a key factor in the “single legal entity” analysis. As stated above, physicians that are only informally affiliated do not qualify as a group practice. Further, the advisory opinion expressly states that Group Practice and the Subsidiaries qualify as a single legal entity “provided that [Group Practice] is the sole owner of the Subsidiaries.” However, it is not necessary for the subsidiary physician practice itself to qualify as a group practice. Below are two diagrams: Diagram 1 illustrates affiliated entities that do not qualify as a group practice, and Diagram 2 illustrates the parent-subsidiary relationship that CMS deemed appropriate in the advisory opinion. Revenue and Expenses Attributed to Parent Given the emphasis CMS put on the framework of Group Practice and the Subsidiaries’ revenue and expenses, this element would likely be considered material. Therefore, subsidiary revenue and expenses should be attributed to the group practice if the entities are looking to qualify as a single legal entity. However, as mentioned above, it is not necessary for a subsidiary physician practice to bill Medicare under the parent. A subsidiary may have its own Medicare number and bill separately from the parent, as long as the revenue and expenses of the subsidiary are ultimately attributed to the parent. Employees and Contractors are Those of the Parent Similarly, if a subsidiary’s employees and/or contractors are not considered to be the employees and/or contractors of the group practice, it is unlikely that the arrangement would fall within the exception, because this, too, was a focus of the opinion and thus is likely material from CMS’s point of view. Conclusion Following issuance of Advisory Opinion No. CMS-AO-2021-01 and recent regulatory changes regarding reliance on advisory opinions, parent physician practices may make referrals for DHS to wholly-owned subsidiary practices as a single legal entity if all other elements of the group practice definition and IOAS exception are met. This advisory opinion only addresses the definition of a single legal entity. Entities must ensure that the other elements of the group practice definition and IOAS exception to the Stark Law are also met if they choose to form a parent/subsidiary referral relationship. Please contact the authors or your regular Dorsey attorney with any questions. Summer Associate Hannah McCallum provided substantial assistance in the drafting of this article.
August 30, 2021