Remarks by Assistant Attorney General Eric Dreiband on the Announcement of Olmstead Settlement with the State of North Dakota

Remarks as prepared for delivery

Good afternoon and thank you for joining us.  Today, we are pleased to announce that the Department of Justice and the State of North Dakota have reached a comprehensive settlement agreement to ensure compliance with the Americans with Disabilities Act.  The agreement commits North Dakota to expand services for individuals with disabilities so, when appropriate, they will be able to choose to remain in their own homes, near family and friends, while receiving the services they need, instead of entering or remaining in nursing facilities to receive care.   

I thank Governor Doug Burgum and the North Dakota legislature for their commitment to improve the lives of people with disabilities.  I also thank the Executive Director of the North Dakota Department of Human Services, Christopher Jones.  We appreciate the collaborative approach that the State displayed in working to resolve the issues that we identified during our investigation. 

Several years ago, the Department of Justice notified North Dakota that it was investigating complaints that the State fails to provide adults with physical disabilities the services that they need to remain in their own homes and live in their communities, leaving them no choice but to live in nursing facilities.  In response, the state cooperated fully with our investigation, including our requests for information.  The parties have now agreed to enter into a pre-suit, comprehensive settlement agreement to resolve the Department’s investigation of the state’s alleged violations of the Americans with Disabilities Act. 

The agreement commits the State to prevent unnecessary segregation by providing community-based services to two groups of people with physical disabilities: those in nursing facilities who choose, and are appropriate, to receive services at home, and those who are at serious risk of being forced into nursing facilities unnecessarily.  These changes will not only benefit people with disabilities, but also their families, friends, and communities throughout the Peace Garden State. 

But what do these changes mean?  For one North Dakotan in his 20s, this agreement means freedom to live life on his own terms.  This young man, who I will call John,[1] has a mobility disability and needs assistance with bathing, dressing, and other activities.  Like so many Americans, he dreams of completing his education, supporting himself, and living in his own apartment.  But under North Dakota’s current system, John must rely on his parents for care that otherwise would only be available to him in a nursing facility.  John and his parents worry that, in the future, when his parents are inevitably unable to assist him, John will be forced to enter a nursing facility, rather than continue to live independently in his own home in the community. 

The settlement agreement will expand choices for John and other people with physical disabilities.  The agreement requires the state to transform its long-term care system so that people with disabilities can remain with their families and communities, while still receiving the care that they need.  The state will provide more than 2,500 people with individualized services.  These services include help with deciding where to live, identifying and arranging for community-based services, and finding accessible housing.  They also include services provided at home, including home health aides to help with daily activities such as bathing and dressing. 

Finally, the agreement includes several provisions designed to ensure that North Dakota develops high-quality long-term care services that are available throughout the state.  The state will hire a subject matter expert to advise the state on how to implement the agreement and to issue public reports.  The state will improve its data collection and quality assurance systems to recognize where gaps in services exist, as well as monitor the health and safety of people who choose to receive community-based services.  And the state will develop a plan detailing how it will complete the reforms in the agreement and engage with stakeholders about the plan.

Enabling people in nursing facilities, who choose and are appropriate for community-based care, to transition to the community is especially urgent during the COVID-19 pandemic, given the high risk of virus transmission in congregate settings.  And, according to a recent report commissioned by the Centers for Medicare and Medicaid Services, serving an individual with community-based services is generally more cost-effective than serving that same person in an institutional setting.[2]

On behalf of our team, I want to say thank you to the individuals with disabilities, families, advocates, and other community members who shared their stories and gave us suggestions on how to improve North Dakota’s long-term care system.  Going forward, we will need your ongoing support and engagement to make sure that the reforms in this agreement are successful.  Thank you also to the providers of community-based services and nursing-facility services in North Dakota who shared their experiences and their vision for a better system.  Your participation in implementing the coming reforms will be essential.

The agreement is a great victory for both the people of North Dakota and its government. With the leadership in this State and the engagement of the community, we believe that North Dakota will serve as a model of how a state can ensure that people with disabilities receive services necessary to remain in their homes and communities, when appropriate.  In light of the level of commitment and cooperation shown, we believe that North Dakota will achieve all of the reforms in the agreement, and more importantly, improve the lives of people like John and his family.  We look forward to working with North Dakota to create that change. 

At this time, I will invite U.S. Attorney Drew Wrigley to offer remarks.  Drew Wrigley and his office have worked closely with the Civil Rights Division on the investigation and the negotiations that produced the settlement agreement. 


[1] This individual gave the Department of Justice permission to share his story under a pseudonym.

[2] Debra J. Lipson, Measures of State Long-Term Services and Supports Rebalancing, HCBS Quality Measures Issue Brief (Nov. 2019) at 2, https://www.medicaid.gov/medicaid/quality-of-care/downloads/hcbs-quality-measures-brief-3-rebalancing.pdf.

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  • Over-The-Counter Drugs: Information on FDA’s Regulation of Most OTC Drugs
    In U.S GAO News
    The Food and Drug Administration (FDA) has regulated most over-the-counter (OTC) drugs—that is, drugs available without a prescription—through the OTC monograph process. FDA has described an OTC monograph as a "rulebook" for marketing safe and effective OTC drugs, such as aspirin, cough and cold medicine, and hand sanitizer. OTC monographs established conditions—such as active ingredients, indications for use, dosage forms, and product labeling—under which an OTC drug was generally recognized as safe and effective. According to FDA officials, before the CARES Act, which was enacted in March 2020, the agency's ability to update and finalize monographs in response to safety issues and to reflect new scientific information was limited by the rulemaking process the agency was required to follow, as well as insufficient resources. Agency officials estimated that it took at least 6 years to complete the required rulemaking process. Additionally, the agency reported it was critically under-resourced to regulate the estimated 100,000 OTC drugs marketed through the monograph process. However, the CARES Act provided for a new process to regulate these OTC drugs rather than the rulemaking process. FDA officials expect it will take less time to update and finalize requirements for OTC drugs using the new process. The CARES Act also authorized FDA to assess user fees to provide additional resources to regulate OTC drugs. Although FDA officials said this new process and user fees should improve its regulation of OTC drugs, the agency's analysis of the effect of the CARES Act is still ongoing. FDA officials told GAO that prior to the CARES Act, they used various methods to identify and respond to safety issues related to OTC drugs. For example, to identify these issues, FDA officials said they read medical literature related to safety issues and reviewed reports submitted to the agency's adverse event reporting system. To respond to these issues, FDA took steps such as issuing drug safety communications to consumers and requesting that manufacturers make changes to a drug's labeling. For example, in 2015, two FDA advisory committees recommended that cough and cold drugs with codeine be removed from the relevant OTC monograph for use in drugs in children. In 2018, FDA also issued a drug safety communication stating the risks outweighed the benefits for the use of these drugs in children. However, FDA officials said these methods were not a substitute for rulemaking because manufacturers could legally market their OTC drugs without making requested safety changes until the rulemaking process was completed. According to FDA officials, the new process for regulating OTC drugs included in the CARES Act could improve FDA's ability to address identified safety risks in a more timely and efficient manner in the future. The act established an expedited process to address safety issues that pose an imminent hazard to public health or to change a drug's labeling to mitigate a significant or unreasonable risk of a serious adverse event. OTC drugs prevent and treat a variety of conditions; for example, sunscreen is used to help prevent sunburn. FDA officials and stakeholders, such as industry representatives and patient and provider groups, have questioned whether the monograph process used to regulate most OTC drugs has been overly burdensome and has limited FDA's ability to quickly update and finalize monographs in response to potential safety issues for consumers. Enacted in March 2020, the CARES Act changed how FDA regulates OTC drugs. The Sunscreen Innovation Act included a provision for GAO to review FDA's regulation of OTC drugs. This report describes, among other issues, (1) the factors that affected FDA's ability to regulate OTC drugs and (2) how FDA identified and responded to safety issues associated with these drugs. GAO reviewed federal statutes and agency documents and interviewed FDA officials and stakeholders familiar with the monograph process. These stakeholders included representatives from the OTC drug industry, health care provider and consumer groups, and researchers. The Department of Health and Human Services provided technical comments on this report, which GAO incorporated as appropriate. For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.
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  • U.S. Trustee Program Reaches Settlement with McKinsey and Company to Withdraw and Waive its Fees in the Westmoreland Coal Bankruptcy Case
    In Crime News
    The Department of Justice’s U.S. Trustee Program (USTP) has entered into a settlement agreement with global consulting firm McKinsey & Company (McKinsey) requiring McKinsey to forego payment of fees in the Westmoreland Coal bankruptcy case pending in the U.S. Bankruptcy Court for the Southern District of Texas (Westmoreland Case). 
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