Nondiscrimination: New HHS regulation affects pharmacies

Final rule is effective July 18, with additional deadlines later this year

A final rule issued by the federal government may allow civil lawsuits against pharmacies that deny language assistance services to patients with limited English proficiency or refuse to treat patients in a manner consistent with their gender identity. The U.S. Department of Health & Human Services (HHS) rule is aimed at advancing health equity and reducing disparities in health care.

The rule, which implements Section 1557 of the Affordable Care Act (ACA), requires health care entities receiving federal financial assistance—such as those that accept Medicaid and Medicare—to engage in certain practices to prevent discrimination on the basis of age, race, color, nationality, or gender, including gender identity. It also applies to programs that HHS itself administers and health plans sold in the marketplace.

The rule’s effective date is July 18, 2016, and includes additional deadlines in October and December.

The heart of the rule

Section 1557 has the distinction of being the first federal rule to prohibit discrimination on the basis of gender identity in federally funded health programs. Previous civil rights laws enforced by HHS’s Office for Civil Rights (OCR) broadly barred discrimination only if based on race, color, national origin, disability, or age. Gender identity discrimination includes refusal to dispense transition-related medications.

HHS clarifies that, in addition to gender identity, discrimination based on pregnancy and sex stereotyping qualifies as sex discrimination.

At the heart of the rule are requirements that pharmacies take reasonable steps to provide meaningful access to individuals with limited English proficiency or a disability, particularly people who are blind or deaf. The rule includes a requirement that pharmacies display posters informing patients that the pharmacy will offer language assistance to patients who need it. HHS will make the notices translated into several languages available online to ease costs and facilitate compliance.

Individuals who pursue civil actions based on Section 1557 can now use the rule’s requirements to help prove that a health care entity discriminated against them, which could expose pharmacies to liability for actions that previously may not have been found discriminatory. The burden is on the plaintiff, however, to prove that services were denied due to discrimination—not simply that the pharmacy failed to provide them. Patients also have the option to submit reports of civil rights violations to the Office for Civil Rights (OCR) at

Next steps for pharmacies

The rule suggests—but does not require—that pharmacies develop language access plans to improve compliance and increase access to language services. It’s not safe harbor from the rule, but having such a plan will weigh favorably in the event of a discrimination complaint or an investigation into whether the entity has taken reasonable steps to provide meaningful access.

“APhA strongly encourages pharmacists to develop a language access plan and discuss cost-saving strategies with their colleagues,” said Jenna Ventresca, JD, APhA Associate Director for Health Policy. “Doing so will help satisfy the rule’s requirements and improve health equity, which will improve patient care.”


For more information, visit for the full article in the upcoming July 2016 issue of Pharmacy Today.