Oregon Publishes Final Rule Requiring Pharmacies to Provide Prescription Label Readers
Continuing the national trend of increased focus on accessibility in health care, the Oregon Board of Pharmacy recently published 855-041-1131 (Rule), requiring pharmacies to notify patients that prescription label readers are available, and to provide the readers to the patients who request one. In order for the readers to work, the pharmacy also must have compatible labels that can be read by the reader. Effective June 23, 2020, the Rule applies to all dispensing drug outlets, including nonresident pharmacies.
The Rule implements legislation that was enacted last year. Effective January 1, 2020, the Oregon Governor signed HB2935, requiring pharmacies to provide visually impaired patients with a prescription label reader. The reader is a device that is programmed to read the prescription label out loud. A chip encoded with the information printed on the label is embedded in the label, and the prescription reader audibly conveys relevant information about dosage, side effects, and other important information, making it possible for visually impaired individuals to discern what the medication is, which prescription bottle they are holding, and other details critical to successful adherence.
Skimpy on the Details, Maximizing Flexibility The Rule is a single regulation, and mainly reiterates language from the statute without amplifying how pharmacies can comply. Specifically, the Rule states:
A pharmacy shall notify each person to whom a prescription drug is dispensed that a prescription reader is available to the person upon request; a prescription reader is a device designed to audibly convey labeling information. A pharmacy that provides a prescription reader shall make it available to the person for at least the duration of the prescription, shall confirm it is appropriate to address the person's visual impairment, and shall ensure that prescription labels are compatible with the prescription reader. This requirement does not apply to an institutional drug outlet, dispensing a drug intended for administration by a healthcare provider. Or. Admin. R. 855-041-1131.
The Rule does not state, and so far there is no guidance from the Board addressing, how pharmacies are supposed to implement this. For example:
- What format must the notice be in?
- Is it acceptable for the notice to be electronic or verbal?
- Must notice be provided with each fill?
- If a patient requests a reader, is it acceptable for the pharmacy to contact the patient's prescriber to confirm the person has a visual impairment?
- Are pharmacies allowed to charge patients for the reader or bill for the replacement cost if the patient does not return it?
This leaves a significant amount of discretion up to the pharmacies. Overall, the cost of providing the readers, tracking who has which reader, and getting them back from patients at the end of a course of medication is expected to be a practical, logistical difficulty for many pharmacy providers if they don't already make readers available to their patients. There is also a risk that some prescription readers may not be returned to the pharmacy, for example, when a patient is no longer receiving medications from the pharmacy, is admitted to a hospital, or dies.
Oregon Focus on Accessibility in Other Areas as Well
In addition to legislation intended to improve access for visually impaired patients, Oregon has also enacted SB698, though it is not effective until January 1, 2021. This statute requires, among other things, prescription labels to contain English plus an additional language, upon request. There are no implementing regulations yet. The Board anticipates starting the rulemaking process for this language accessibility requirement next month. Quarles & Brady will send an alert when the Board releases for public comment a draft of the proposed rules.
Part of a Larger Trend
Over the past several years, states and the federal government have increased focus on ensuring patient accessibility to prescription information and health care services in languages that the patient can understand, and through assistive devices to help people control and manage their own treatment. Health care providers, including pharmacies, can be the target of complaints, enforcement action or, when it comes websites in particular, litigation, due to noncompliance with the growing body of accessibility requirements.
At the federal level, requirements stem from the Americans with Disabilities Act (ADA) and the Affordable Care Act (ACA), among others. For example, the US Department of Justice, through enforcement of the ADA, requires websites be accessible and, in several states, particularly under human rights laws in California and New York, companies have been the target of lawsuits based on accessibility issues with websites or apps. In addition, Section 1557 of the ACA prohibits health care providers from discriminating on the ground of race, color, national origin, sex, age, or disability in certain health programs and activities, and requires providers to have policies and procedures delineating how the provider makes care accessible (such as through the availability of translation services, telephone relay service, and other strategies).
At the state level, pharmacy boards have been focused primarily on language assistance for several years, and the trend is now expanding to assistive devices, such as the prescription label readers. California, New York, and others have requirements in place related to translation or interpretation services, including providing label information in multiple languages and notices to patients about the availability of pharmacy services in their preferred language. Many contracts or accreditations will also require provision of translation and interpretation services.
Technology is making strides to increase accessibility for patients in new ways. Regulations requiring implementation of the technology, to bring it to bear in a mass way, offer benefits and challenges. The benefits of such requirements include increased medication effectiveness and patient safety through ensuring people understand what their medication is for and how to take it correctly. The expanding requirements also increase the regulatory burden, compliance risk, and cost for pharmacies. The challenge of some of them, such as with products like the label readers, may be difficult to implement in a practical, cost-effective way without also generating inefficiency or other operational challenges. Cooperation among regulators, pharmacies, and patients may be necessary to ensure the best outcomes possible as technology continues to make strides in improving accessibility and the industry learns how to incorporate the new technology into patient care.
OneSource Staffing Settles EEOC Discrimination Charges
The U.S. Equal Employment Opportunity Commission (EEOC) and Wilkes-Barre, Pa.-based staffing firm OneSource Staffing, LLC reached a voluntary conciliation agreement to resolve two discrimination charges, the federal agency announced today.
The EEOC’s investigation into two disability discrimination charges revealed that OneSource Staffing required, as a condition of employment, that workers execute a mandatory arbitration agreement for disputes arising out of employment, including any arising under anti-discrimination laws enforced by the EEOC. The EEOC determined that the OneSource Staffing sought to enforce the agreement to prohibit employees from filing charges of discrimination with the EEOC and that such conduct was unlawful retaliation and interference with an individual’s exercise of rights under the Americans with Disabilities Act (ADA).
OneSource Staffing, LLC denied that it engaged in unlawful conduct but agreed to a voluntary resolution of the charges.
The ADA prohibits employment discrimination based on disability. It prohibits employers from engaging in retaliation because an employee opposed discrimination or filed a charge with the EEOC. It is also unlawful to coerce, intimidate, threaten or otherwise interfere with an individual’s exercise of ADA rights, or with an individual who is assisting another to exercise ADA rights.
In the conciliation agreement, OneSource Staffing agreed not to engage in employment discrimination or retaliation in the future. OneSource Staffing agrees it will modify its arbitration policy and notify employees that the arbitration agreement does not prohibit an employee from filing a charge with the EEOC, having the case investigated by the EEOC or from participating in an EEOC investigation. It will not use the arbitration agreement as a defense to any charge filed with the EEOC. The staffing company will also post a notice about the voluntary settlement. The EEOC will monitor compliance with the voluntary settlement for one year.
Bias charges in mastectomy case reinstated
A federal appeals court has overturned a lower court and reinstated discrimination charges filed by a daycare worker who was terminated after she took time off for a prophylactic double mastectomy.
Sherryl Darby, who had a family history of cancer and a genetic mutation known as BRCA1, filed suit against Springboro, Ohio-based Childvine where she had worked as an administrative assistant, charging it with violating the Americans with Disabilities Act and Ohio law for firing her soon after she had the procedure, according to Tuesday’s ruling by the 6th U.S. Circuit Court of Appeals in Cincinnati in Sherryl Darby v. Childvine, Inc.; Tyler Mayhugh; Samantha Blizzard.
Shortly after she began work, Ms. Darby asked for time off for a double mastectomy later that month.
The supervisor “balked at the idea” and asked her to delay her surgery until her 90-day probationary period ended. Ms. Darby agreed to move the procedure the day after her probationary period expired.
She was allegedly “harassed” by the supervisor and Childvine’s co-owner about the length of her leave request. When she returned to work, she was told Childvine had already sent her a letter informing her of her termination.
The letter was effective the last day of her probationary period and reasons listed for her termination included “unpleasant” attitude, dress code violations and “being unable to work,” the ruling said.
Ms. Darby filed suit against the daycare facility in U.S. District Court in Cincinnati, which granted Childvine’s motion to dismiss the case.
The ruling was overturned by a unanimous three-judge appeals court panel.
“The key point of contention between the parties is…whether Darby’s genetic mutation constitutes a disability under the ADA. Darby argues her condition so qualifies because it is a ‘physical or mental impairment that substantially limits one or more (of her) major life activities,’” said the ruling, in citing the ADA.
It is “at least plausible, at this stage, that Darby’s gene mutation and abnormal cell growth, though not cancerous, qualify as a disability under the ADA,” the ruling said. Her claims “are entitled to further consideration through discovery.”
While it is not deciding whether Ms. Darby’s condition “in fact falls under the ADA’s definition of a disability,” her “factual allegations are sufficient to survive a motion to dismiss,” said the ruling, in remanding the case for further proceedings.
Attorneys in the case could not be reached for comment.
Press Release: DOJ Warns of Inaccurate Information re Face Masks and the ADA
Disabled ex-firefighter says civil rights violated by hospital’s refusal to treat him without mask
A retired firefighter with reactive airway disease said his civil rights were violated by a local hospital that denied him an appointment over his refusal to wear a face mask, despite having access to medical records documenting his physical disabilities.
Autism Is an Identity, Not a Disease: Inside the Neurodiversity Movement
Activists argue that rather than trying to ‘cure’ or treat the neurodivergent, society should learn to accept, appreciate, and accommodate their needs
Question of the Day: Accommodation Obligations
Is an employee entitled to an accommodation to avoid exposing a family member who is at higher risk of severe illness from COVID-19 due to an underlying medical condition?
Answer
Many businesses have been faced with requests for accommodations from employees who are personally at high risk for contracting COVID-19, such as continuing to work remotely, limiting contact with customers or moving workstations to increase social distancing. However, employees are increasingly raising concerns about returning to the workplace not because of their own disability or high-risk condition, but because they do not wish to expose members of their families who are at high risk of severe illness from COVID-19.
This raises the question – does an employer have an obligation to provide an accommodation because of a family member’s health condition? On June 11, 2020, the EEOC answered that question in additional guidance issued on accommodation obligations under the Americans with Disabilities Act (ADA). The EEOC concluded there is no obligation to provide an accommodation to the employee to avoid exposure to a high-risk family member. The EEOC stated: “[t]he ADA does not require that an employer accommodate an employee without a disability based on the disability-related needs of a family member or other person with whom she is associated.”
In doing so, the EEOC provided the following now common example:
[A]n employee without a disability is not entitled under the ADA to telework as an accommodation in order to protect a family member with a disability from potential COVID-19 exposure.
As noted by the EEOC, while not required to do so, an employer may choose to provide some flexibility to employees under these circumstances. So, what are your options when an employee will not come back to work out of fear of exposing a family member to COVID-19 should you decide to provide some kind of flexibility? Depending on the nature of the employee’s position, you have several options:
- Determine if the employee’s job can be performed remotely. If so, offer to have the employee continue to work from home.
- Determine if there are modifications that you can make to the employee’s job that might limit that employee’s exposure to other employees or customers in the workplace.
- If the employee cannot perform work remotely and/or will not come back even with modifications to the worksite, offer the employee a personal leave of absence until the employee feels comfortable coming back to work. This may not work for all positions and you may not be able to guarantee the employee a job at the end of the leave – but you can consider the employee for open positions when they are ready to return to work. The employee may or may not be eligible for unemployment under these circumstances.
- Consider a temporary layoff with instructions that the employee could apply for unemployment – but be sure to let them know that you, as the employer, do not make eligibility determinations for unemployment compensation purposes.
When engaging in conversation with your employee about options, be transparent. If you are going to need to fill the employee’s position during any time away from work to ensure continued business operations, be clear with employees that you cannot guarantee them a position when they are ready to come back to work. Also, should you choose to exercise flexibility for employees in this situation, be sure to apply those decisions consistently and use objective measures.