Food and Drug Administration

The U.S. Department of Justice reached a January 31, 2019 settlement of an American with Disabilities Act (“ADA”) Title III complaint against health care provider Selma Medical Associates relating to provision of medical services to an individual with opioid use disorder (“OUD”).  The settlement is notable for health care providers and employers as it makes clear that DOJ considers OUD as a disability under the ADA thereby triggering the full panoply of ADA rights for those with OUD.

The DOJ complaint was premised on the alleged refusal of Selma Medical to schedule a new patient family practice appointment after the patient disclosed he takes Suboxone.  Suboxone is a prescription medication approved by the Food and Drug Administration for treating OUD.  The complaint further alleged that Selma refused to treat patients with narcotic controlled substances, including Suboxone, thus imposing “eligibility criteria that screen out or tend to screen out individuals with OUD.”  The compliant also alleged a failure to make reasonable accommodations to policies, practices or procedures when necessary “to afford such goods, services, facilities, privileges, advantages, or accommodations to individuals with disabilities.”

Under the settlement, Selma agreed to:

  1. Not discriminate or deny services on the basis of disability, including OUD;
  2. Not use eligibility standards, criteria or methods of administration that tend to deny benefits on the basis of disability including OUD;
  3. To modify its policies as necessary;
  4. To draft and submit within 30 days for DOJ approval a non-discrimination policy and to remove any inappropriate existing policies;
  5. After DOJ approval, to adopt and disseminate to all employees the new non-discrimination policy;
  6. To train all management and employees within 60 days and annually for three years as to the new policy and ADA compliance with the initial training conducted live, with a Q&A opportunity, and by a trainer to be approved by DOJ;
  7. Submit compliance reports to DOJ for three years; and
  8. To pay compliant $30,000 in damages and a civil penalty to the U.S. of $10,000.

The DOJ-Selma Medical settlement is highly significant in an environment where in 2015, OUD affected 2 million people aged 12 and over (Drug and Alcohol Dependence, Vol. 169, Dec. 2016, pp. 117-127) and .6 million persons aged 12 or over had heroin use disorder (id.) and the lifetime percentage of individuals with Diagnostic and Statistical Manual-IV prescription OUD among adults 18 and over had more than doubled from 1.4% in 2001-2002 to 2.9% in 2012-2013 (id.), and likely higher today.  And, of course, this does not include those who are OUD for reasons other than prescriptions.  This means that health care providers are highly likely to encounter significant numbers of potentially challenging OUD patients.  DOJ has now made clear that providing the full range of care and services to such patients is required under the ADA – and that any failure to do so can lead to litigation, costly settlements and adverse publicity.

All employers, not just health care providers, should take note of this settlement as it clearly means that employers will also need to reasonably accommodate employees who seek time off for treatment or other accommodations unless the employer cannot show the requested accommodations would be an undue hardship.

The Selma Medical settlement is also a reminder that health care providers should make sure they have appropriate non-discrimination policies in place as required pursuant to Health and Human Services regulations for compliance under Title III of the ADA, the Rehabilitation Act of 1973, and the non-discrimination requirements of Section 1557 of the Affordable Care Act.  We can assist with any questions regarding the required policies and other issues as to compliance with the ADA, the Rehab Act and Section 1557.

 

Our colleague at Epstein Becker Green has a post on the Health Law Advisor blog that will be of interest to our readers in the health care industry: “NIST Seeks Comments on Cybersecurity Standards For Patient Imaging Devices.”

Following is an excerpt:

The National Institute of Standards and Technology (“NIST) has announced that it will be seeking industry input on developing “use cases” for its framework of cybersecurity standards related to patient imaging devices. NIST, a component of the Department of Commerce, is the agency assigned to the development and promulgation of policies, guidelines and regulations dealing with cybersecurity standards and best practices. NIST claims that its cybersecurity program promotes innovation and competitiveness by advancing measurement science, standards, and related technology in ways that enhance economic security and quality of life. Its standards and best practices address interoperability, usability and privacy continues to be critical for the nation. NIST’s latest announcement is directed at eventually providing security guidance for the healthcare sector’s most common uses of data, inasmuch as that industry has increasingly come under attack. …

Read the full post here.