On December 28, 2021, directors from the Quality, Safety and Oversight Group at The Centers for Medicare and Medicaid Services (CMS) released a memorandum (QSO-22-07-ALL) outlining its procedures for surveying compliance under its November 5, 2021, Omnibus COVID-19 Health Care Staff Vaccination Interim Final Rule (IFR). The memorandum references various attachments for specific provider types which supplement and are intended to be used in conjunction with it.

The guidance requires all Medicare and Medicaid-certified facilities to comply with the IFR’s vaccine requirements by January 27, 2022. This means facilities subject to the IFR must provide at least the first dose of a COVID-19 vaccine to 100 percent of its staff or have a pending or granted qualifying exemption. Noncompliance with the IFR will result in a variety of enforcement remedies, including civil monetary penalties, denial of payments and, as a final resort, termination of participation in Medicare and Medicaid programs.

The CMS guidance and appetite for enforcement of the IFR comes as a surprise because of the numerous legal challenges since its release in November. Although the IFR is currently stayed in 25 states, CMS has indicated that it will move forward with enforcement in the states that are not part of the ongoing litigation. The U.S. Supreme Court is expected to hear oral arguments on the IFR on January 7, 2022. For now, covered providers in the states subject to the guidance and IFR should comply until the Supreme Court has ruled on the vaccine requirements.

For questions or assistance with compliance of the CMS vaccine requirements, please contact Kathy Butler in Greensfelder’s Health Care group.

In 2019, the Centers for Medicare and Medicaid Services (CMS) issued draft guidance on hospital co-location (when hospitals share space and resources with other health care entities). We previously summarized that draft guidance here. On November 12, 2021, CMS issued its final guidance and — surprise! — it changed quite a bit.

Generally, the changes may create more flexibility for hospitals, but they also create a tremendous amount of confusion and will undoubtedly be applied differently by surveyors across the country. Let’s take a look at the specific changes in the final guidance and what impact they may have.

Health Care Entities/Providers. The draft guidance simply stated that hospitals may co-locate with other hospitals as well as with “other healthcare entities.” Those other entities were not defined or limited in any meaningful manner. The final guidance states that hospitals may co-locate with “other healthcare providers,” but specifically excludes from that term both critical access hospitals (CAHs) — “due to specific distance and location requirements” — and “private physician offices” — “including those that may be participating in a timesharing or leasing agreement.”

Technically, this exclusion means the final guidance doesn’t address co-location with CAHs and private physician offices. But it does not necessarily mean that co-location with those entities is prohibited. It could be permitted on different terms. Because it remains unclear, we recommend asking for guidance from your applicable state Department of Health before undertaking a major project. There is a risk that any such co-location will be identified as a violation by a surveyor.

Shared Spaces. Here, CMS made fairly sweeping changes to its draft guidance, including the following:

• The draft guidance distinguishes between “distinct” spaces — which would remain separate and under the hospital’s control at all times — and “shared” spaces — which could be jointly utilized by both co-locating entities. The final guidance gets rid of this distinction in its entirety.
• The draft guidance flatly prohibited the sharing of “clinical spaces designated for patient care,” as it could jeopardize patient safety and confidentiality. The final guidance includes no such blanket prohibition. In fact, it doesn’t specifically discuss the sharing of clinical spaces at all.
• The draft guidance went into detail about “public spaces and public paths of travel” that may be shared. These areas included lobbies, waiting rooms, reception areas, public restrooms, elevators, and others. The draft guidance made clear that paths of travel could never go through a clinical area. Again, the final guidance gets rid of this entire discussion.

In lieu of all this detail, the final guidance simply states that “each entity is responsible for demonstrating its compliance with all applicable Medicare and Medicaid program participation requirements” and leaves it up to the hospital to “consider whether the hospital’s spaces that are used by another co-located provider risk their compliance with” Medicare’s Conditions of Participation. The guidance goes on to identify several factors that hospitals should consider, such as patient rights, patient safety, infection prevention and control, governing body, and others.

Contracted Services. Little to no substantive changes were made to this section. The final guidance merely clarifies that services a hospital obtains via contract with a co-located entity, but under the oversight of the hospital’s governing body, “would be treated as any other service provided directly by the hospital.”

Hospital Staffing. The draft guidance prohibited hospital staff from “floating” between entities during a single shift, working at one entity while being “on-call” at another, and providing services to both entities simultaneously. It went on to state that it would not be possible for a nurse to be “immediately available” under 42 C.F.R. § 482.23(b) if he or she is working in multiple physical locations, or for multiple providers, at the same time.

The final guidance gets rid of these per se violations. It simply states that, “[w]hen hospital staff are obtained under arrangement from another entity, there should be evidence that the hospital’s staff are meeting the needs of patients for whom they are providing care. Additionally, the staffing must meet the statutory and regulatory requirements for the activity.” That’s it. Staff floating and similar arrangements may be permissible in some instances.

Emergency Services. Not surprisingly, given its dislike of staff floating arrangements, the draft guidance stated that contracting with another entity for emergency services is not permitted when contracted staff are working for or on-call at another entity, and that a hospital cannot satisfy its obligations by having another hospital respond to its emergencies. The final guidance deletes these specific limitations, leaving the issues open.

Survey Procedures. The draft guidance included nearly four pages of discussion of how surveys with co-located hospitals will be conducted. It stated documents and information surveyors would request, what they would be looking for on- and off-site, and how potential violations would be addressed. The final guidance trims this all down to a single page. In lieu of detailed procedures, the guidance gives fairly broad discretion to surveyors as to what to request and how to proceed.

Ultimately, the final guidance improves flexibility for hospitals while adding a frustrating amount of confusion. It is likely this guidance will be applied and enforced differently from surveyor to surveyor, making it difficult to provide concrete guidance to hospitals on what is and is not permissible. When evaluating co-location with another entity, it is important for a hospital to review the applicable Conditions of Participation and verify if and how the requirements will be satisfied.

We should also remember that this guidance does not supersede state licensing laws! Just because CMS permits hospital co-location — albeit within somewhat vague parameters — does not mean that a state licensing agency or other authority will permit it.

As originally drafted, the Illinois Freedom to Work Act (IFWA) only barred employers from entering into non-compete agreements with “low wage employees,” i.e., those making no more than minimum wage or $13 per hour, whichever is greater. In 2022, the law is expanding to include broader limitations on non-competes and, for the first time, non-solicitation agreements.

The new IFWA will impact virtually all health care employers, including hospitals, medical practices, dental practices and others, which frequently use non-compete and non-solicitation agreements for their health care professionals. The following addresses several aspects of the law for health care providers.

Chris Bailey previously did an excellent job summarizing the law here, including additional details on certain notice requirements and enforcement of the IFWA.

When do the changes take effect?

The new requirements under the IFWA apply to agreements containing non-compete and non-solicitation agreements that are “entered into” after January 1, 2022.

So existing agreements are OK?

Generally, yes. However, the law does not define what it means to “enter into” an agreement, and there are some circumstances where the law’s application is open to interpretation.

First, agreements with physicians and other health care professionals are frequently amended or restated at various intervals. So even though an employment agreement may have been originally entered into prior to January 1, 2022, if the agreement is restated in its entirety on or after January 1, 2022, it should always be reviewed to ensure compliance with the new law.

Second, if an amendment to a pre-existing agreement directly changes any terms of the non-compete or non-solicitation provisions, then the agreement containing the applicable provision is arguably being “entered into” at the time of the amendment and should comply with the new law.

Finally, amendments that change other contractual provisions — and which might indirectly alter the scope or terms of the non-compete or non-solicitation covenants — should be carefully reviewed. In most cases, because of the risk that an agreement might be declared void and unenforceable, the non-compete and non-solicitation provisions should be brought into compliance at the time of any amendment on or after January 1, 2022.

Are there any special rules or requirements for health care workers or employers?

No. Health care employers and workers are not exempt from the law, and there are no special rules for them. Hospitals and other employers will have to comply just like any other employer.

How much compensation must an employee receive before an agreement becomes enforceable?

For a non-compete to be enforceable, an employee’s actual or expected rate of earnings must exceed $75,000 per year. This minimum increases by $5,000 every five years, reaching $90,000 as of January 1, 2037.

For a non-solicitation agreement to be enforceable, an employee’s actual or expected rate of earnings must exceed $45,000 per year. This amount increases by $2,500 every five years, reaching $52,500 as of January 1, 2037.

How are annualized earnings calculated?

“Earnings” specifically includes all forms of taxable income reported or “expected to be” reported on the employee’s W2 as “wages, tips, and other compensation.” For example, bonuses will need to be included, as will any taxable fringe benefits, such as any cash and cash equivalents, an employer-provided car, and fees for professional licenses and dues that are not paid under an Internal Revenue Code Section 62 “accountable plan.”

Earnings also includes an employee’s non-taxable elective deferrals, such as “employee contributions to a 401(k) plan, a 403(b) plan, a flexible spending account, or a health savings account, or commuter benefit-related deductions.” It also includes other types of welfare benefits that may be elected and paid under an Internal Revenue Code Section 125 Cafeteria Plan, such as medical, dental and vision premiums and supplemental life and disability coverage.

In many cases, the earnings of physicians and other health care workers will be high enough that the earnings threshold will not be in question. For others, an estimate of the employee’s earnings will need to be calculated.

Are there any types of health care workers for whom non-competes and non-solicitation agreements cannot be used?

Yes. There are a couple of relevant limitations.

First, a health care provider cannot “enter into” a non-compete or non-solicitation agreement with any employee who is terminated, furloughed or laid off as a result of the COVID-19 pandemic unless during the term of the non-compete the employee is paid his or her base salary at the time of termination, minus any compensation earned through subsequent employment. Since this restriction only bars agreements entered into as a result of a COVID-related employment change, pre-existing non-competes and non-solicitation agreements should still be enforceable.

It’s not entirely clear that a COVID-related non-solicitation agreement may also be enforceable if the employee’s base salary is paid, since the IFWA only expressly references non-competes in that part of the rule. More guidance is needed. Until then, an employer seeking to enforce a non-solicitation agreement entered into as a result of a COVID-related employment change should also enter into a non-compete at the same time, in addition to continuing to pay the base salary during the term of the non-compete (minus other earnings).

Second, an agreement entered into “by a person purchasing or selling the goodwill of a business or otherwise acquiring or disposing of an ownership interest” is excluded from the definition of a non-compete. So transactions involving the ownership of health care practices may include non-competes without being subject to the IFWA. Any non-solicitation agreement included in the transaction, however, would still be subject to the IFWA.

Other exceptions — for example, certain collectively bargained public and education employees, as well as construction employees — are not relevant to private health care providers.

What limitations are there on the scope of a non-compete or non-solicitation agreement?

To be enforceable, an agreement must satisfy the following five rules:

• The employee receives adequate consideration;
• The covenant is ancillary to a valid employment relationship;
• The covenant is no greater than is required for the protection of a legitimate business interest of the employer;
• The covenant does not impose undue hardship on the employee; and
• The covenant is not injurious to the public.

These requirements by and large track those that already existed under the common law, as do the factors that go into examining the legitimate business interests of the employer. As a result, health care providers will not likely need to rework the scopes of agreement as a result of the IFWA, such as service, time and geographic limitations.

For questions or assistance with compliance with the act, please reach out to any of Greensfelder’s Health Care attorneys.

The No Surprises Act, which then-President Trump signed into law on December 27, 2020, as part of the Consolidated Appropriations Act of 2021, addresses surprise medical bills from out-of-network providers when patients believe they are seeking care from in-network providers. Most sections of the act go into effect on January 1, 2022, and the Departments of Health and Human Services, Treasury, and Labor are working on regulations to implement many provisions of the act.

Below is a high-level overview of the key provisions. Click here for the full text of the act.

Requirements imposed on health insurance plans (Section 101)

There are detailed requirements mandating health plan compliance with respect to coverage for out-of-network emergency services and certain non-emergency services performed by out-of-network providers at in-network facilities, as described in more detail below. These requirements will apply to comprehensive individual and group health plans, including fully insured plans sold through the individual and group markets, as well as self-funded ERISA plans. Health insurers will be required to cover emergency services without any prior authorization regardless of whether the provider is in or out of network. Such services will be provided as if patients were in-network, with payment made by the health plan directly to the provider rather than directing the payments to the patients. Patients will be responsible for the same cost-sharing amounts they would have if the services were provided by an in-network provider. The same is true for non-emergency services provided by out-of-network providers subject to the notice and consent exception, discussed in more detail below.

Determination of out-of-network rates and independent dispute resolution process (Section 103)

Section 103 of the act sets forth several avenues to determine the rates for out-of-network services along with an independent resolution process through which health plans and providers may resolve any reimbursement issues.

Health care provider requirements (Section 104)

The key provision for patient protection under the act lies in Section 104. On the effective date of January 1, 2022, out-of-network health care providers (including facilities, physicians and non-physician practitioners) may not balance bill patients for covered emergency services or certain covered non-emergency services provided at in-network facilities unless certain conditions are met.

Patients who seek care from an out-of-network provider will not be balance billed for emergency services with respect to an emergency condition. For emergencies, the act’s definitions track the definitions in the Emergency Medical Treatment & Labor Act (EMTALA). The term “emergency services” means a “medical screening examination” that is within the capability of the emergency department of a hospital or of an independent freestanding emergency department, including ancillary services routinely available to the emergency department to evaluate such emergency medical condition and any other medical examinations and treatment to stabilize the patient.” For non-emergency services, out-of-network providers may not bill or balance bill (for any amounts not covered by the applicable insurance plan) patients for services provided, unless certain notice and consent requirements are met. The notice and consent requirements will be met if:

1. the patient is provided written notice and consent 72 hours in advance of the appointment;
2. the notice includes a good-faith estimate of the costs of the services; and
3. the notice provides a list of in-network providers at the facility and information regarding any prior authorizations, if applicable.

The foregoing notice and consent procedures, however, are not available for the following services: radiology, pathology, emergency, anesthesiology, diagnostic and neonatal services, assistant surgeons, hospitalists, and intensivists, and, therefore, patients may not be billed beyond their in-network cost-sharing amounts for these services. Notice and consent also is prohibited for providers offering services when no other in-network provider is available. Once the regulations are issued, this list may be expanded or some diagnostic laboratory tests may be removed.

This section will allow the Secretary of Health and Human Services to apply civil monetary penalties of up to $10,000 per violation, but may provide some exemptions or waive the penalties if the provider did not knowingly violate this section and corrects the violation.

Protections against air ambulance bills (Section 105)

The act also aims to protect patients from receiving surprise medical bills for out-of-network air ambulance services. Patients will be required to pay only the in-network cost-sharing amount for out-of-network air ambulances. Those amounts could then count toward the patient’s cost-sharing toward any deductibles the patient may have.

Transparency regarding in-network and out-of-network deductibles and out-of-pocket limitations (Section 107)

As of the effective date, health plans offering group and individual health insurance coverage will be required to include the following information on insurance cards:

1. all plan deductibles, including in-network and out-of-network deductible amounts, if applicable;
2. maximum limits on out-of-pocket costs, including in-network and out-of-network out-of-pocket cost limits, if applicable; and
3. a telephone number and web address for consumer assistance information, including information on in-network providers.

Patient protections through transparency and patient-provider dispute resolution process (Section 112)

The act establishes a new requirement for health care providers to give insured and uninsured patients “good faith estimates” in the form of an Advanced Explanation of Benefits (“AEOB”) as discussed in more detail below. The “good faith estimate” will provide the total expected charges for scheduled items or services, including the billing and diagnostic codes. Health care providers will be required to furnish this information for items or services scheduled at least three days in advance or whenever a patient requests it. Should a patient receive a substantially higher bill than the “good faith estimate,” the act and corresponding regulations will establish a patient-provider resolution process through which such discrepancies will be resolved.

The AEOB requirement (Section 111)

The act sets out detailed requirements for the information that must be included in the AEOB:

1. whether the provider or facility will be in-network for that particular item or service;
2. the “good faith estimate” of expected charges, including likely billing and diagnostic codes;
3. a “good faith estimate” of the insurance plan’s payment responsibility;
4. a “good faith estimate” of the patient’s expected cost-sharing amount based on the notification date and not the date of service;
5. a “good faith estimate” of the amount the patient has incurred toward meeting his or her financial responsibility limits such as their deductible and out-of-pocket costs;
6. a disclaimer that coverage for the item or service is subject to any prior authorizations, if applicable;
7. a disclaimer that information included in the AEOB is an estimate based on the information known at the time of scheduling and subject to change; and
8. any other information health plans determine to be appropriate to be included.

Continuity of care requirement (Section 113)

This section of the act requires health plans to ensure continuity of services when a health plan makes a change in its provider network. This protection will be extended to a patient defined as a “continuing care patient” who receives treatment for a serious or complex condition, undergoes institutional or inpatient care, is scheduled to undergo non-elective surgery including post-operative care, is pregnant and undergoing treatment, or is terminally ill and receives services. In these cases, health plans will be required to timely notify patients of any changes in the network status of its providers and facilities. The act will allow these patients to have up to 90 days of continued coverage at in-network prices to allow the patient time to transition to an in-network provider.

Conclusion

The act includes many transparency and compliance provisions for both health plans and health care providers that will need to be understood and implemented. The implementing regulations for the statute are being drafted by a number of government agencies (including the Departments of Health and Human Services, Labor, and Treasury) and will be published for notice and comment during 2021, in advance of the effective date. Given the breath and detail of the statutory requirements, the implementing regulations will be of great interest to health care providers and health plans. As these regulations are released, we will provide updates.

For questions or assistance with compliance with the act, please reach out to any of Greensfelder’s Health Care attorneys.

If an offer to a health care provider to speak at or attend a pharmaceutical or medical device company’s event seems too good to be true – it probably is, and it could lead to civil, criminal and federal administrative penalties.  

On November 16, 2020, the Office of Inspector General (OIG) issued a Special Fraud Alert relating to offers, payments, solicitation or receipt of remuneration for “speaker programs” sponsored by pharmaceutical and medical device companies. The OIG defines “speaker programs” as these companies’ “sponsored events at which a physician or other health care professional (collectively, HCP) makes a speech or presentation to other HCPs about a drug or device product or a disease state on behalf of such Companies.” The company pays the speaker HCP an honorarium, and often pays remuneration (for example, free meals) to the attendees. The OIG found that in the past three years, such companies “have reported paying nearly $2 billion to HCPs for speaker-related services.”

The OIG and the Department of Justice (DOJ) investigated and resolved multiple such cases involving violations of the anti-kickback statute. Notably, the government filed civil and criminal charges against both the HCP and the company. For these cases, the government alleged that drug and device companies:  

• selected high-prescribing HCPs to be speakers and rewarded them with lucrative speaker deals (e.g., some HCPs received hundreds of thousands of dollars for speaking);
• conditioned speaker remuneration on sales targets (e.g., required speaker HCPs to write a minimum number of prescriptions in order to receive the speaker honoraria);
• held speaker programs at entertainment venues or during recreational events or otherwise in a manner not conducive to an educational presentation (e.g., wineries, sports stadiums, fishing trips, golf clubs, and adult entertainment facilities);
• held programs at high-end restaurants where expensive meals and alcohol were served (e.g., in one case, the average food and alcohol cost per attendee was over $500); and
• invited an audience of HCP attendees who had previously attended the same program or HCPs’ friends, significant others or family members who did not have a legitimate business reason to attend the program.

These cases implicated the federal anti-kickback statute (AKS), which makes it a criminal offense to “knowingly and willfully solicit, receive, offer or pay any remuneration to induce or reward, among other things, referrals for, or orders of, items or services reimbursable by a Federal health care program.” When intent is present for the remuneration to induce or reward referrals of items or services payable by a federal health care program, the AKS is violated. 

The OIG is skeptical about these “speaking arrangements” for violations of the AKS because

“HCPs receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend.” The OIG noted that such circumstances “strongly suggest that one purpose of the remuneration to the HCP speaker and attendees is to induce or reward referrals.” The OIG has also found that “HCPs who receive remuneration from a company are more likely to prescribe or order that company’s products,” which may most likely “skew” HCPs’ clinical decision-making that may not be in the patients’ best interests.

In this Special Fraud Alert, the OIG cautioned that it will closely scrutinize such arrangements and reminded HCPs that this is not a new policy change, as the OIG has previously expressed concerns relating to these arrangements. Whether a speaking arrangement will pass muster under the OIG’s lens will depend on the facts and circumstances of each case and intent of the parties. According to the OIG, such intent may be evidenced by the speaker program’s characteristics and the actual conduct of the parties involved. The OIG also provided certain “illustrative and not exhaustive indicators,” which “taken separately or together may potentially indicate” an arrangement that could violate the AKS. Those are:  

• The company sponsors speaker programs where little or no substantive information is actually presented;
• Alcohol is available or a meal exceeding modest value is provided to the attendees of the program (the concern is heightened when the alcohol is free);
• The program is held at a location that is not conducive to the exchange of educational information (e.g., restaurants or entertainment or sports venues);
• The company sponsors a large number of programs on the same or substantially the same topic or product, especially in situations involving no recent substantive change in relevant information;
• There has been a significant period of time with no new medical or scientific information nor a new FDA-approved or cleared indication for the product;
• HCPs attend programs on the same or substantially the same topics more than once (as either a repeat attendee or as an attendee after being a speaker on the same or substantially the same topic);
• Attendees include individuals who don’t have a legitimate business reason to attend the program, including, for example, friends, significant others or family members of the speaker or HCP attendee; employees or medical professionals who are members of the speaker’s own medical practice; staff of facilities for which the speaker is a medical director; and other individuals with no use for the information;
• The company’s sales or marketing business units influence the selection of speakers or the company selects HCP speakers or attendees based on past or expected revenue that the speakers or attendees have or will generate by prescribing or ordering the company’s product(s) (e.g., a return on investment analysis is considered in identifying participants);
• The company pays HCP speakers more than fair market value for the speaking service or pays compensation that takes into account the volume or value of past business generated or potential future business generated by the HCPs.

In conclusion, the OIG is again cautioning provider of its concerns about companies offering or paying remuneration (and HCPs soliciting or receiving remuneration) for speaker programs. If the circumstances are suspicious, as outlined above, and requisite intent to induce referrals is present, both the company and the HCP may be subject to civil, criminal and administrative enforcement actions. HCPs should also ensure that they do not violate any applicable state anti-kickback rules.  

We recommend our clients review and, if necessary, revise, their compliance programs and/or policies involving HCPs attending and receiving remuneration for speaker programs offered by these companies. Any such compensation should be carefully analyzed in light of this Special Alert, which can be found at https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/SpecialFraudAlertSpeakerPrograms.pdf. 

For any questions or assistance with arranging speaker programs in compliance with federal and state law, please contact Kathy Butler or Sanja Ord in Greensfelder’s Health Care group. 

On November 10, 2020, the U.S. Supreme Court held oral arguments in California, et. al. v. Texas, et. al., the most recent challenge to the Patient Protection and Affordable Care Act (ACA).

By way of brief background, the Supreme Court addressed the constitutionality of the ACA in 2012 in National Federation of Independent Business v. Sebelius. In the Sebelius case, the ACA provision that required most Americans to maintain “minimum essential coverage” (i.e., the individual mandate) was at issue. The Court held in Sebelius that the individual mandate was constitutional under Congress’s authority to lay and collect taxes.[1] In 2017, Congress amended the ACA through the Tax Cuts and Jobs Act, which as of January 1, 2019, reduced to zero an individual’s tax penalty for failing to maintain minimum essential coverage. Once the tax penalty was removed, litigation arose regarding whether the ACA was still constitutional.

In 2018 in Texas v. United States, the U.S. District Court for the Northern District of Texas declared the individual mandate unconstitutional. The court also held that the remaining provisions of the ACA were invalid because they were inseverable from the individual mandate. The U.S. Court of Appeals for the Fifth Circuit affirmed the district court’s decision regarding the individual mandate, but it remanded on the issue of severability. The Supreme Court granted certiorari to the case, consolidated as California v. Texas, and heard oral arguments on November 10, 2020.

More than half of the oral arguments related to a legal theory called standing. In layman’s terms, a person or legal entity must have an actual injury from a law to contest the law, and this is typically called standing. All nine justices asked at least one question regarding the states’ standing and the individual citizens’ standing, as there is no longer a tax penalty under the individual mandate for failing to purchase minimum essential coverage. The states had seven grounds to argue states were injured, but the clear focus at the hearing was injury to a state’s pocketbook due to numerous obligations under the ACA that cost states money. The individual citizens had several arguments, but the primary argument was the mandate to purchase insurance they did not desire to purchase.

Justices Breyer, Sotomayor, and Kagan made clear that they do not believe the petitioners have standing. Once the individual mandate was removed, no individual has been forced to purchase anything. Justice Breyer in particular argued the individual mandate is now really just a suggestion. Further, the states are required to meet obligations under the ACA that the states claimed caused injury, including paperwork, by provisions other than the individual mandate. Thus, the states are not injured by the individual mandate. The newest member of the court, Justice Amy Coney Barrett, gave indications that she agreed, at least partially, with the more liberal justices on standing. She had difficulty understanding how the individual mandate required any paperwork from the states. She used the word “traceable” and argued that the injury alleged by the states was not related to the individual mandate. Moreover, based on the questioning from Chief Justice Roberts and Justice Alito, it can be suggested that Justices Roberts and Alito may agree with Justice Barrett.

If five justices find that the parties have standing, then the court must address whether the individual mandate is unconstitutional, and, if the court holds it to be unconstitutional, whether it may be severed from the ACA. It seemed rather apparent that at least five justices believe the individual mandate is severable. Of course, oral arguments can be misleading. However, at face value, Justices Roberts, Breyer, Sotomayor, Kagan, and Kavanaugh indicated they are leaning toward finding the individual mandate severable from the rest of the ACA. Chief Justice Roberts went so far as to say it is not the court’s job to do that which Congress did not. He raised the fact that Congress had the chance to repeal the law, and it did not do so. Instead, Congress reduced the tax penalty related to the individual mandate to zero, with many members of Congress openly stating that they repealed the individual mandate. Justice Kavanaugh asked the attorney representing the respondents, “Isn’t it clear that the proper remedy is to sever the mandate?”

Justice Thomas indicated that he might not want to reach the question of severability at this time. The opinions of Justices Gorsuch, Alito, and Barrett on the severability question were difficult to interpret. The attorney for Texas and the other respondents and the attorney for the petitioners focused heavily on a clause or clauses in the original ACA, which they argued indicated the individual mandate could not be severed. There was tremendous discussion between the justices and the attorneys for the parties on whether Congress actually drafted a severability clause in the original ACA. Even if Congress did, some of the justices argued it was no longer relevant after the ACA was amended in 2017.

Finally, it must be noted, the last question asked at oral argument was whether the 2012 Sebelius case definitively resolved the issue of whether Congress had authority to enact the individual mandate under the Commerce Clause. This is important because there are three new justices to the Court since Sebelius was decided. Justices Breyer, Sotomayor, and Kagan clearly stated in Sebelius that they believed the individual mandate was a valid exercise of the Commerce Clause. If Justice Barrett and either Justice Gorsuch or Justice Kavanaugh agree, then the Commerce Clause may be an entirely new basis for upholding the individual mandate and the ACA.

[1] Four justices found the ACA to be constitutional under the Commerce Clause, but five disagreed.

Greensfelder Officer Amy Blaisdell was recently quoted in an article for SHRM about a federal judge in New York temporarily blocking a regulation that was going to remove some health care protections for transgender individuals. The article, titled “HHS Blocked from Rolling Back Health Care Protections for Transgender Workers,” was published on August 18, 2020.

As noted in the article, the U.S. Department of Health and Human Services was going to roll back such protections because they were previously thought unenforceable. However, under Title VII of the Civil Rights Act of 1964, “The Supreme Court’s decision not only prohibits an employer from refusing to hire or discharging an employee based on LGBTQ status, but also prohibits treating employees differently in the spectrum of compensation, terms or conditions of employment because of the individual’s LGBTQ status,” says Blaisdell.

Read the full article at SHRM.org.

Greensfelder Officer Amy Blaisdell recently co-authored an article in For the Defense, a publication of the Defense Research Institute (DRI), about lessons employers should keep in mind when defending against disability benefits claims that lack objective medical evidence. The article, titled “Objective Versus Subjective Evidence in the ERISA Claims-Handling Process,” was published in the August 2020 edition.

As noted in the article, disability claimants regularly take the position that certain difficult-to-diagnose conditions cannot be proven through objective medical evidence. As such, they argue that it is unreasonable or arbitrary for an administrator of a disability plan governed by ERISA to require objective evidence of these disabling conditions.

The notion that subjective symptoms must be given at least some level of consideration has gained traction in the federal courts recently. However, there are ways to organize a defense to increase the likelihood of success on the merits. These include:

• focusing on the language in the plan;
• highlighting evidence in the record that demonstrates that subjective evidence was considered, even if was ultimately found to be insufficient;
• focusing on the lack of impairment evidence, rather than the diagnosis; and
• carefully considering the role of credibility in your arguments.

Read the full article by Amy Blaisdell and former Greensfelder associate Dan Ritter in For the Defense.