CJ Wolf
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The holiday season is a great time to spread happiness and cheer. However, the holiday season can also bring up varying compliance issues unique to the holidays. Two major areas of questions and sometimes compliance hotline questions are (1) navigating varying belief systems and (2) gifts and potential violations surrounding gift-giving and receiving.
Navigating Varying Belief Systems
The holiday season may unintentionally bring about tensions or feelings of being left out regarding varying belief systems and celebrating certain holidays. There may be a predominant religious or secular holiday that most employees celebrate, but only focusing on one holiday may exclude others. For example, Christians may celebrate Christmas, some folks celebrate Yule or the winter solstice, those of the Jewish faith may celebrate Hanukkah, others may celebrate Kwanzaa. And some folks don’t celebrate anything during this time of year.
Most organizations have mission, vision, and values statements and/or codes of ethics that clearly state they value diversity and want to be an inclusive employer. Some organizations might even have an office of diversity and inclusion, which includes a diversity and inclusion officer leading the organization in this area.
For example, the Cleveland Clinic’s website statements on diversity include the following statement:
“Diversity plays a key role at Cleveland Clinic as well as all healthcare organizations because it affects interactions between employees and the patients and families served. As a global healthcare provider and the largest employer in Northeast Ohio, diversity is an inherent aspect of interaction with patients, employees, and the community.” https://my.clevelandclinic.org/about/community/diversity/about
Their office of diversity and inclusion states diversity encompasses qualities in three categories:
- Human (race, gender, sexual orientation, ethnicity, age)
- Cultural (language, religion, class, ethics, values)
- Systems (organizational role and function, geographic location, organizational culture)
The holiday season may be a good time to review the organization’s goals and policies for diversity.
Some ideas for approaching the holiday season may include:
- Listing all the various holidays and belief systems that employees wish to celebrate
- Don’t focus on one holiday alone
- If having a party or social event, don’t make it mandatory as some employees may not wish to participate
- For workplace celebrations, consider an all-inclusive celebration and allow employees to share something they value and explain why they celebrate or recognize it at this time of year
Learning about what others value can bring teams and organizations closer together. However, this type of sharing must be done appropriately. There are many interfaith types of organizations whose missions include bringing understanding to varying belief systems. A couple of examples include the United Religions Initiative at https://www.uri.org/ and the Tanenbaum Center for Interreligious Understanding https://tanenbaum.org/about-us/what-we-do/workplace/workplace-resources/
Some of the workplace resources available at Tanenbaum include:
- Religious Diversity Checklist
- 10 Bias Danger Signs
- Eight Steps to the Accommodation Mindset
- Fact sheets on various holidays and values including Christmas, Baha’i New Year/Naw Ruz, Conscientious Refusals, Diwali, Easter, Eid al-Adha, Hanukkah, Kwanzaa, Lunar New Year, Passover, Pioneer Day, Ramadan, Religious Icons and Symbols: A Guide for Workplaces, Vaisakhi, and Vesak Day
- Respectful Communication
Sometimes, even with the best intentions, feelings may get hurt or policies, or even the law, may be violated or suspected to be violated. In these circumstances, the compliance officer may receive hotline calls or direct messages about concerns of non-inclusion or violations. Human resources departments are also often involved. Most institutions have an equal employment opportunity policy (see an example from a medical center here: https://ippvip.mdanderson.org/OnBaseWebIPPExternalPRD/docpop/docpop.aspx?KT337_0_0_0=Published&KT377_0_0_0=Y&KT354_0_0_0=Y&KT345_0_0_0=ADM0284&clienttype=html&cqid=142&vieweronlyforsingle=true&chksum=8745307c5111c7ca8378c08ad690241597d4b813bfb270995133ce85dc0c8153)
The EEOC also has some guidance on religious accommodation in the workplace. https://www.eeoc.gov/laws/guidance/what-you-should-know-workplace-religious-accommodation
In summary, most organizations state they value diversity. The holiday season is a perfect time to demonstrate how they value diversity by making sure the organization is thoughtful in holiday celebrations and recognitions and maintaining compliance with policy and the law. For further insights, consider this article from the Society for Human Resource Management https://www.shrm.org/hr-today/news/hr-magazine/1118/pages/how-to-make-holiday-celebrations-more-inclusive.aspx.
Gift Giving and Receiving: Destroying Trust, COIs, and Stark
Giving and receiving gifts is almost synonymous with the end of year holidays. In most industries, gift-giving is allowed and widely accepted. However, in the healthcare industry, gift-giving and receiving can run afoul of various laws and regulations even if intentions are good. We don’t mean to be a Grinch, Scrooge, or buzz kill, but unfortunately, some gifts might cross the line.
Two federal laws that could be implicated include the Federal Anti-Kickback Statute and the Stark Law. Most states have similar laws and public entities (think state-owned/county-owned hospitals and university systems). They usually have additional restrictions regarding the legal definition of “public servant,” which often includes employees of public hospitals/health care entities.
Gifts to Patients (Beneficiaries)
Federal law states a person who offers or transfers to a Medicare or Medicaid beneficiary any remuneration that the person knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of Medicare or Medicaid payable items or services may be liable for civil money penalties (CMPs) of up to $10,000 for each wrongful act.
This includes gifts, which could influence a patient’s decision in choosing a provider. The OIG issued a Special Advisory Bulletin: (https://oig.hhs.gov/documents/special-advisory-bulletins/886/SABGiftsandInducements.pdf) in an attempt to clarify gift giving the influence it could have on patients’ choices.
In the bulletin, the OIG stated,
“Offering valuable gifts to beneficiaries to influence their choice of a Medicare or Medicaid provider raises quality and cost concerns. Providers may have an economic incentive to offset the additional costs attributable to the giveaway by providing unnecessary services or substituting cheaper or lower-quality services. The use of giveaways to attract business also favors large providers with greater financial resources for such activities, disadvantaging smaller providers and businesses.”
But the OIG also gives their interpretation of what might be considered a valuable or expensive gift instead of an inexpensive gift that is not likely to influence a patient’s decision-making. The OIG “has interpreted the prohibition to permit Medicare or Medicaid providers to offer beneficiaries inexpensive gifts (other than cash or cash equivalents) or services without violating the statute. For enforcement purposes, inexpensive gifts or services have a retail value of no more than $10 individually and no more than $50 in the aggregate annually per patient.”
Rather than thread the needle, so to speak, or document individual amounts to monitor the aggregate threshold, most healthcare providers simply have internal policies stating that gifts to patients are not permitted.
Gifts to Physicians and Hospitals
The overarching issue with gifts to healthcare providers is the risk that those gifts affect medical decision-making. It then becomes an issue of trust and safety.
Dr. Harvey Fineberg has stated,
"Preservation of trust is the essential purpose of policies about conflict of interest. Physicians have many important roles, including caring for individual patients, protecting the public’s health, engaging in research, reporting scientific and clinical discoveries, crafting professional guidelines, and advising policymakers and regulatory bodies. Success in all these functions depends on others—laypersons, professional peers, and policy leaders—believing and acting on the word of physicians. Therefore, the confidence of others in physician judgment is of paramount importance. When trust in physician judgment is impaired, the role of physicians is diminished.”
But can gifts make a difference? Small gifts might not make as big a difference as larger payments, but studies have shown all transfers of value have some effect. For example, a recent study published in the Annals of Internal Medicine. This study reviewed the medical literature, which found 36 studies comprising 101 analyses. Most studies (n = 30) identified a positive association between payments and prescribing in all analyses; the remainder (n = 6) had a mix of positive and null findings. No study had only null findings. Of 101 individual analyses, 89 identified a positive association. Payments were associated with increased prescribing of the paying company's drug, increased prescribing costs, and increased prescribing of branded medicines. Nine studies assessed and found evidence of a temporal association; 25 assessed and found a dose-response relationship. The authors concluded that “the association between industry payments and physician prescribing was consistent across all studies that have evaluated this association. Findings regarding a temporal association and dose-response suggest a causal relationship.”
Additional studies have found similar results. ii, iii
Anti-Kickback Statute
The federal Anti-Kickback Statute ("AKS") prohibits soliciting, offering, giving, or receiving remuneration (e.g., gifts) in exchange for referrals for items or services covered by Medicare, Medicaid, or other federal healthcare programs unless the arrangement fits within a regulatory exception. Even if the primary purpose of the gift does not have this intent, you can still run afoul of the AKS. The “one purpose” rule states that if even one purpose of the remuneration is in exchange for referrals for items or services, the AKS has been violated.
For example, a physician assistant agreed to pay $25,000 to settle allegations that she received different kickbacks from a pharmaceutical company through its sales representatives and executives. The alleged items of values she accepted included improper in-office and out-of-office meals and food items, gift cards, and gifts.
Not all gifts to physicians come from the pharmaceutical and medical device industries. Potential referral recipients (hospitals, etc.) might provide physicians with gifts. In this scenario, it’s also essential to assess gifts in the context of the Stark laws.
Stark Law
According to law firm Hall Render, iv, under the federal Stark law, hospitals may provide non-monetary compensation to physicians up to an aggregate amount of $429 for the calendar year 2021. The dollar limit for “medical staff incidental benefits” (e.g., meals, parking, and other items or incidental services used on the hospital’s campus) is less than $37 per occurrence. Other requirements of the Stark Law’s exception for non-monetary compensation and medical staff incidental benefits must also be met. Hospitals should take inventory of such non-monetary compensation and benefits to confirm they meet the law’s requirements. Some of the conditions include the requirement that the compensation is not determined in any manner that takes into account the volume or value of referrals or other business generated by the referring physician, and the compensation may not be solicited by the physician or the physician’s practice (including employees and staff members).
At any rate, a detailed analysis by someone well versed in the Stark law requirements is essential as there are many details and requirements that need consideration.
Restrictions for Public Organizations
If you work for a public organization (typically a state- or county-owned hospital), there might be additional restrictions regarding gift-giving/receiving.
For example, a hospital that is part of the University of Texas system has listed in their gift-receiving training that “A state officer or employee should not … accept or solicit any gift, favor, or service that might reasonably tend to influence the officer or employee in the discharge of official duties or that the officer or employee knows or should know is being offered with the intent to influence the officer's or employee's official conduct…” (Tex. Gov’t. Code § 572.051(a)(1)
Additionally, there is a “Gift to Public Servant” statute that governs state employees (Tex. Pen. Code § 36.08(d)). It states, in part, that “a public servant who exercises discretion in connection with contracts, purchases, payments, claims, or other pecuniary transactions of government commits an offense if he solicits, accepts, or agrees to accept any benefit from a person the public servant knows is interested in or likely to become interested in any contract, purchase, payment, claim, or transaction involving the exercise of his discretion.”
Good Intentions Can Still Break Compliance Rules
So, we hope we haven’t soured the joys of the holidays with all this nay-saying, and you’re still excited to celebrate this time of year. We know most gift-giving and holiday celebrations have good intentions. But we hope we’ve reminded the conscientious compliance professional that even good intentions can sometimes run afoul of compliance rules and regulations.
We wish you and yours a happy (and compliant) holiday season.
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Sources
i Are Financial Payments From the Pharmaceutical Industry Associated With Physician Prescribing? A Systematic Review. Aaron P. Mitchell, MD, MPH, et al. Annals of Internal Medicine, Vol. 174 No. 3, March 2021.
ii Association between payments from manufacturers of pharmaceuticals to physicians and regional prescribing. William Fleischman, et al. BMJ, 15 Aug 2016, Vol. 354
iii The Effects of Pharmaceutical Firm Enticements on Physician Prescribing Patterns·There's No Such Thing as a Free Lunch. James P. Orlowski, M.D., F.C.C. R; and Leon Wateska, R.Ph., M.S., Chest 1992; 102:270-73.
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