https://www.michigan.gov/mdhhs/doing-business/providers/certificateofneed/commission/2026-commission-minutes

On behalf of the Michigan Certificate of Need (CON) Commission, the Michigan Department of Health and Human Services (MDHHS) held a public hearing on the Hospital Beds and Magnetic Resonance Imaging (MRI) Services Review Standards on Tuesday, August 11, 2026 at 9:30 a.m.

Written testimony received during this public hearing has been posted and can be found on the the 2026 Commission Minutes, Public Testimony, and Transcripts webpage. No verbal testimony was received during the public hearing.

If you have any questions, please contact the CON Policy Office at MDHHS-ConWebTeam@michigan.gov.

https://www.mackinac.org/blog/2026/michigan-needs-more-nursing-homes-why-are-we-still-blocking-them

Michigan needs more nursing homes; why are we still blocking them?

Certificate of Need laws deliberately limit health care for seniors

Jeffery L. Degner    |    July 28, 2026

Imagine being confined to a nursing home bed, falling out and breaking a femur. When you complain of the pain, you aren’t offered any pain medication, and you have to wait 20 hours before being sent to an emergency room.

This situation isn’t fiction for one Michigan-based patient. While the facility and many like it maintain a respectable online rating, inspections by the Center for Medicare and Medicaid Studies paint a different picture. Unfortunately, Michigan’s nursing homes and long-term care facilities are characterized by overloaded staff, bed shortages, and decreased quality of care.

The pathology that causes these sub-standard outcomes in all but 11 states has a name: Certificate of Need, or CON. Most Michigan residents are unaware that Certificate of Need laws deliberately limit their supply of nursing homes, MRI machines, and psychiatric beds. These goods and services are in high demand, and limiting supplies inevitably results in higher prices.

Michigan’s Certificate of Need Board determines the supply of medical care. It has two inherent flaws. The first is conflict of interest. While board members themselves may not directly benefit from their roles on the board, the hospital systems and insurers they represent stand to gain financially by blocking new competitors or from limiting their own services.

Michigan’s CON Board is filled by 11 unelected members who are appointed by the governor and approved by the Senate. They are required to declare conflicts of interest in every meeting. However, the board’s bylaws only vaguely define conflicts and leave it to board members to decide whether one exists.

This sets the stage for problematic incentives that tend to result in tit-for-tat voting patterns. Most people would view this set of incentives and probable outcomes as being full of conflicts of interest. Likely due to this weak definition, in the nine meetings held in 2024 and 2025, there was only one record of a voting abstention due to conflict of interest.

The second flaw is what’s known as “technocratic washing.” The CON Board outsources its bed-need decision to a complicated, 47-year-old clustering algorithm. Some CON board members have voiced concerns about the need to increase the number of nursing homes and beds, particularly in rural areas. But ultimately, the determination of whether the state needs new beds is not made by physicians or patients. Instead, the decision comes from a mathematical formula.

In meeting transcripts from January 2025, the statistician who developed the algorithm reported to the CON Board that for 2024, the state only needed 41,400 beds. The actual number at that time was 44,689. In other words, the algorithm’s output said that the state should eliminate 3,289 beds. In 2025, the same calculation would have the board believe that there were 2,792 too many nursing homes and long-term care beds.

According to the state of Michigan, the 75-84 age group may grow by approximately 45% by 2039. With Michigan seniors already paying $485 per day for nursing home beds, it’s no time to limit their supply. That daily price is nearly $30 more than the national average, and $75 per day more than it is in states without CON regulations (excluding California and Pennsylvania). The difference adds up to more than $2,000 more per patient per month in Michigan. Higher-than-average costs and higher-than-average occupancy would unquestionably invite more competition in a free market. Instead, Michigan’s CON board calls for the opposite.

Nursing facility expansion is a decision that should be handled by doctors, patients, or elder-care advocates. Instead, Michigan maintains a system that limits competition, reduces availability, and provides worse patient outcomes. The obvious solution would be to allow new competitors into this critical area of need.

State lawmakers may be unaware that special interests on the CON Board limit competition under the guise of high-sounding mathematics. In states where these boards don’t exist, citizens pay nearly 25% less per nursing home bed than in states like Michigan. In an age where affordability is on everyone’s mind, and where the senior population is surging, our lawmakers must set aside partisan differences and special interest loyalties in order to unleash competitive forces that better serve our aging population.

A dedicated facebook group was started in November 13, 2026, with the following description:

"This private group is a space for concerned families and students to discuss ongoing potential mold issues in Michigan State dorms- will will NOT censor mold-related posts!
Our mission is to advocate for meaningful action from the university to eliminate any found health hazards and ensure safe, healthy living conditions for all students."

The group currently shows 426 members.

https://www.facebook.com/groups/1201927225330102/

The school's official web page "Mold 101" shows an extensive FAQ list, linked to further information.

https://liveon.msu.edu/Mold-101

Mold & Mildew Prevention: What you need to know

Residence Education and Housing Services (REHS) engages in routine maintenance efforts to prevent maintenance and mold concerns. Buildings and residence hall rooms are inspected multiple times per year. If you believe that you have mold in your on-campus living space, we recommend that you complete a maintenance request so that REHS is notified and can respond. REHS will respond to reports of mold following industry best practices established by the Institute of Inspection, Cleaning and Restoration Certification (IICRC).

What causes mold to grow?
Where is mold and mildew found?
Are there state or national regulations regarding mold?
Why not conduct mold testing?
How does mold spread?
Is it safe for me to stay in my residence hall that currently has mold?
How does mold affect people?
What will be done if there is mold found in my living space?
What if there is no mold found in my living space, but I am still concerned?
What can I do to prevent or limit mold and mildew growth?

First, a Daily Signal op-ed gives the national the national perspective. 

What does your college student say?

https://www.dailysignal.com/2026/08/04/hidden-health-college-dorms/

The Hidden Health Risk in College Dorms

August 4, 2026

Every student knows the smell.

The musty odor from an air vent. The dark stain spreading across a dorm ceiling. The damp corner of a communal bathroom.

Most students barely notice it. Others joke about it.

What many do not realize is that mold is more than an ugly stain or an unpleasant odor. Federal health agencies have linked mold exposure to a plethora of health issues. Yet mold in college housing remains one of the least-discussed student health issues on American campuses.

One of the authors of the present piece knows several college students who have experienced headaches and persistent coughs that were seemingly caused by moldy living conditions.

College dormitories are highly susceptible to mold growth. Aging buildings, shared bathrooms, poor ventilation, plumbing leaks, high humidity, and delayed maintenance all create ideal conditions for moisture to accumulate. Educational buildings frequently experience moisture-related issues.

When water intrusion from leaks or flooding is not addressed quickly and thoroughly, mold can begin growing within 24 to 48 hours. Yet students are forced to trust and rely on universities to identify, remediate, and communicate potential hazards.

In the last five years, dorm mold has been reported at colleges and universities in 42 out of the 50 states, with media reports of mold issues at 75% of Ivy League institutions. Even at schools known for offering some of the nation’s most prestigious educations, many students have often been denied something far more fundamental: a safe and healthy place to live. Academic excellence means little if students are forced to learn in housing conditions that may compromise their health.

Too often, mold in college housing is dismissed as little more than a maintenance issue rather than the public health concern it can become. The Centers for Disease Control and Prevention links exposure to damp, moldy environments with respiratory symptoms, chronic coughing, asthma attacks, and allergic reactions, while noting that persistent moisture and flooding create ideal conditions for mold growth.

Public health experts estimate that roughly half of U.S. homes have conditions associated with dampness or mold, and one widely cited analysis found that approximately 21% of asthma cases in the United States are attributable to dampness and mold exposure. Emerging research also suggests that mold may affect more than just the respiratory system, with a 2020 study in Brain, Behavior, and Immunity finding that mold inhalation triggered neuroinflammation and cognitive changes in animal models.

Additionally, it can be difficult for students to recognize when their living environments may be contributing to their health problems. Fatigue, frequent headaches, respiratory issues, or recurring illnesses are often dismissed as a normal part of adjusting to college life, which may include late nights, increased stress, poor sleep, or less-than-ideal dining hall food. As a result, a dorm’s indoor air quality or mold exposure as a culprit for health hazards is often overlooked, delaying both recognition of the problem and action.

This issue rarely receives the attention it deserves, and many colleges require students to live on campus for at least the first year—often at significant monetary cost. With that requirement and expenditure comes a responsibility to provide housing that is safe, healthy, and properly maintained. Students should not have to choose between pursuing their education and protecting their health.

A clean, well-maintained dormitory is not a luxury; it is the foundation of student success. Universities invest enormous resources in student wellness, but wellness begins with the place students sleep, study, and live.

Institutions cannot claim to prioritize student health while treating mold as an insignificant facilities problem. If colleges are truly committed to investing in the next generation, providing safe, healthy housing should not be optional—it should be the standard.


Romey Crumbaugh is a member of Heritage’s Young Leaders Program.

Jennifer Galardi is a senior policy analyst, Restoring American Wellness at The Heritage Foundation.

Clipped here for length.

https://kffhealthnews.org/insurance/prior-authorization-insurance-denials-reform-pledge-year-later/

Insurers Hedge on Trump-Backed Pledge To Improve Denials Process

Lauren Sausser and Renuka Rayasam July 17, 2026

One year after the Trump administration announced that dozens of health insurers had signed a six-part pledge promising to reduce barriers to doctor-recommended care, some insurers now say they won’t implement all the promised initiatives.

Meanwhile, patients, their advocates, and clinicians say little has improved.

“It has never been this bad for patients,” said U.S. Rep. Greg Murphy (R-N.C.), a physician who co-chairs the GOP Doctors Caucus.

We Want To Hear Your Story.
Do you have experience with prior authorization you’d like to share with us for KFF Health News’ reporting? Click here to reach us.

The overarching intent of the June 2025 pledge was to improve a controversial process called prior authorization, which regularly requires patients or someone on their medical team to seek approval from insurers before proceeding with treatment.

According to AHIP, the health insurance industry trade group, health plans have eliminated 6.5 million prior authorizations for patients — equal to an 11% reduction — since the announcement.

But critics remain skeptical. Sally Nix, a patient advocate who has a chronic disease, described the voluntary pledge as “performative.” And Murphy, who participated in the news conference with Health and Human Services Secretary Robert F. Kennedy Jr. announcing the pledge last year, said it has “no teeth.”

Voluntary insurer pledges rarely make things better for patients, said Sabrina Corlette, a research professor at the Center on Health Insurance Reforms at Georgetown University.

“In the absence of clear rules, policies, standards, and mandates,” she said, insurance companies are “going to do what makes sense for them to do financially.”

The Department of Health and Human Services did not respond to questions for this report. It isn’t clear how, or whether, the Trump administration is holding insurers accountable.

<clip>

Beckers provides a 360-degree update. Many source links recommended at the original post.

https://www.beckersasc.com/asc-coding-billing-and-collections/the-beginning-of-the-end-for-prior-authorization/

The beginning of the end for prior authorization?

Francesca Mathewes    |    August 25, 2026

For nearly as long as health insurers have used prior authorization to control costs, physicians and hospitals have argued it does more harm than good.

The pushback against prior authorization has reached new heights in recent months as healthcare leadership, legislators and physician advocacy organizations have proposed major reforms or outright bans of the practice.

Here are 10 notes on where things stand.

1. A health insurance CEO says prior authorization should be illegal. Patrick Quigley, CEO of El Segundo, Calif.-based Sidecar Health, told Becker’s that the industry’s signature cost-control tool creates more waste than it prevents.

“We are creating massive amounts of waste in our system, and we are controlling cost within the system simply by denying care,” he said.

Mr. Quigley argued the fix isn’t reforming prior authorization — it’s eliminating it. “The right path is actually to stop and make prior authorization illegal,” he said. “Why do we need prior authorization at all? Instead, focus on creating transparency around decisions, around costs, around quality, so that people can naturally make better decisions, because that’s going to lower costs.”

2. The denial data behind his frustration is now public. Under new reporting requirements, Medicare Advantage, Medicaid managed care and ACA marketplace plans must publicly disclose how often they deny prior authorization requests and how often those denials get overturned on appeal. A KFF analysis found denial rates ranging from 12% to 18% across the three markets, while appeal overturn rates hit 67% for Medicare Advantage, 47% for Medicaid and 43% on the marketplace — including one insurer, Centene, that overturned 93% of its appealed Medicare Advantage denials. About 150 million Americans with employer-sponsored coverage aren’t captured by the reporting requirement at all.

3. The lack of transparency around prior auth has a price tag. A policy brief from the American Economic Liberties Project, cited alongside Mr. Quigley’s case for banning prior authorization, put the administrative burden created by the process at the equivalent of more than 99,000 full-time clinicians and up to $32.7 billion a year.

4. CMS just closed transparency loopholes the AMA says insurers were exploiting. The 2024 Interoperability and Prior Authorization rule requires health plans to publicly post their prior authorization requirements and outcomes. But when the American Medical Association reviewed 15 Medicare Advantage contracts, it found plans technically complying while making the information nearly impossible to use — hundreds of pages of billing codes with no plain-language explanation, disclosures buried behind password-protected portals, and entire categories of care omitted altogether.

“Patients should not need a portal password, a billing manual or medical training to find and understand a health plan’s prior authorization practices,” said Willie Underwood III, MD, president of the American Medical Association.

Following the AMA’s findings, CMS updated its guidance to clarify that password-protected portals don’t satisfy disclosure requirements and to require plain-language descriptions, standardized service categories and machine-readable formats. Dr. Underwood called it “an important step,” but said “the work is not finished.”

5. Insurers say their pledges are working. Physicians see something different. About 50 insurers covering 257 million Americans committed in June 2025 to streamline prior authorization. AHIP and the Blue Cross Blue Shield Association have since reported an 11% reduction in requirements, with some Medicare Advantage plans exceeding 15%.

“During the past 10 months, the Blues made significant, measurable strides toward delivering on our promise to make this process faster, simpler and more transparent,” said Kim Keck, CEO of the Chicago-based Blue Cross Blue Shield Association.

Physicians report a different reality. In an AMA survey, 94% said prior authorization negatively affects patient outcomes, and just 1% reported a positive impact; 26% documented serious adverse events tied to a delay or denial, including hospitalization (23%), a life-threatening event (18%) or disability or death (8%). Among physicians who contract with UnitedHealthcare and Cigna — two insurers that pledged reform — only 16% said they’d actually seen requirements decrease.

6. For ASCs, the burden is growing, not shrinking. In 2024, 46% of ASC cases required prior authorization, up from 42% the year before — and only 24% of those authorizations were completed on the first attempt.

7. Insurers’ own finances help explain the squeeze. Seventy-three percent of health plans reported operating losses in 2025. Over the same period, 54% of revenue cycle leaders said claim denials are increasing, and 41% said at least 1 in 10 claims are now being rejected — the same dynamic Mr. Quigley described insurers using prior authorization to manage.

8. Washington’s AI-driven fix is facing bipartisan pushback. CMS’s WISeR (Wasteful and Inappropriate Service Reduction) pilot, which uses artificial intelligence to review Medicare claims, launched Jan. 1 in Arizona, New Jersey, Ohio, Oklahoma, Texas and Washington and is set to run through 2031. The House Appropriations Committee voted June 9 to block its funding, and 31 House Democrats have asked CMS for pilot data, citing reports of denials and longer wait times. A report from Sen. Maria Cantwell, D-Wash., found authorization wait times in pilot states have grown two to four times longer — to 10 to 15 days, from one to two days before the program began.

9. States aren’t waiting on Washington. A Massachusetts law that took effect June 5 restricts prior authorization for roughly half of the state’s commercially insured residents, prohibiting it for emergency and urgent care, primary care, imaging after a cancer diagnosis, preventive services, maternity care and substance use disorder treatment.

10. One reform meant to ease the burden is under utilized. Gold-carding programs exempt physicians with strong approval track records from prior authorization altogether. But only 10% of physicians contract with health plans that offer one. In the meantime, practices complete an average of 39 prior authorizations per physician each week, spend 13 hours on the paperwork, and in 40% of cases employ staff whose job is dedicated to prior authorization alone.

This model's concept, pioneered by Scott L. Zeller, MD, takes off from Julius Caesar's conquest of Gaul - divide and conquer. No matter who tries to legislate physical/mental health parity, they are very different things in an emergency.

I can only imagine how relieved these ED staff are to be able to focus on heart attacks, overdoses, and traumatic injuries. 

https://www.beckersbehavioralhealth.com/care-coordination/how-1-uk-healthcare-unit-cut-ed-boarding-time-92/

How 1 unit cut UK HealthCare’s ED boarding time 92%

Ella Ruder    |    August 11, 2026

University of Kentucky HealthCare based in Lexington opened an Emergency Psychiatric Assessment, Treatment and Healing (EmPATH) unit in July 2024 to treat behavioral health patients outside its emergency departments — a design choice that differs from many models nationally.

The unit sits near Eastern State Hospital in Lexington and serves both of UK HealthCare’s EDs, at Good Samaritan Hospital and Chandler Hospital. About 5,000 patients a year come through its doors, and it has treated more than 10,000 people in its first two years — more volume than leaders initially expected, said Marc Woods, DNP, RN, chief nursing officer for Eastern State Hospital, the EmPATH unit and the Good Samaritan behavioral health unit.

The unit follows the EmPATH model developed by Scott Zeller, MD, though Mr. Woods said implementation varies widely by health system. “I think the statement is if you’ve seen one EmPATH, you’ve seen one EmPATH,” he said.

A model built on inclusion

UK HealthCare’s unit accepts patients other crisis programs might turn away, including those who are aggressive or violent, according to Mr. Woods and Lindsey Jasinski, PhD, chief administrative officer and director of psychology services at Eastern State Hospital.

“We use a statement of ‘find a way to say yes to this patient in front of you.’ Finding a way to say yes not just in fancy meetings or report offs — we say it to our staff. Traditionally in behavioral health, that hasn’t been the case,” Mr. Woods said. Dr. Jasinski described the shift as moving to “how do we operate on inclusion criteria,” rather than exclusion criteria.

Despite treating a broader patient population, Dr. Jasinski said restraint use on the unit is below 0.01%. She attributed that to staff building rapport with patients immediately, offering food and drink on arrival, allowing patients to keep their clothes and belongings when safe, and watching closely for signs of escalation throughout a patient’s stay.

The unit also employs peer support specialists — staff with lived experience of mental illness or substance use disorder — a role Mr. Woods said EDs typically lack. He recalled a patient telling him, “You don’t know what I’ve been through. You can’t help me,” before a peer support specialist stepped in and said, “He can’t, but I can, and I’ve been where you are.”

Suicidal ideation is the most common presentation, accounting for almost 60% of patients, according to Mr. Woods. Patients arrive by ambulance, police transport, family, rideshare, bus or on foot, Dr. Jasinski said, and the unit has drawn patients from roughly 30 states, though Mr. Woods attributed some of that reach to Lexington being a college town. If a patient presents at either UK HealthCare ED instead, staff arrange an ambulance transfer to the unit.

The program is built around a 23-hour observation stay. “Our No. 1 goal is that after 23 hours, you leave here with hope,” Dr. Jasinski said. “We’ve turned a crisis into an outpatient appointment.”

Very few patients progress to inpatient admission, Mr. Woods said, which he said helps preserve scarce behavioral health beds for the most acute cases. The unit has expanded capacity since opening with 12 chairs to roughly 20 today.

Fewer repeat visits, more follow-through

Leaders pointed to a decline in frequent ED use among behavioral health patients since the unit opened. In its first six months, Dr. Jasinski said, patients who had previously been coming to the ED an average of 5.5 times every six months were instead returning to the EmPATH unit about twice in six months.

Follow-up appointment attendance has also improved. Before the unit opened, patients discharged from the hospital attended follow-up appointments about 29% of the time, according to Dr. Jasinski; since then, that rate has held at 65% for two years. A community mental health center co-located inside the unit helps patients schedule follow-up care, typically within 24 to 48 hours of discharge, before they leave.

First-year data showed a 63.5% reduction in inpatient admissions and a 92.1% reduction in ED boarding time tied to the unit’s opening. Asked about year two, Dr. Jasinski said those operational gains have held steady, while Mr. Woods said tracking restraint use against ED baselines has been a harder metric to capture consistently.

“Each is a new opportunity for us to reevaluate what that person needs,” she said. “We might start treatment, but the biggest thing that we do is connect them to those resources in the community.”

Kentucky has proposed using CMS rural health transformation dollars to fund additional EmPATH units across the state over the next five years, Dr. Jasinski said, citing the model’s effect on access to care. The unit also arranges transportation home for rural patients who arrive by ambulance but have no way to get back.

Effects on the emergency department

Before the EmPATH unit opened, Good Samaritan’s emergency department relied on four specially secured rooms within its 21-bed unit to hold behavioral health patients, Eric Reid, MD, Medical Director of Good Samaritan emergency department and medical director of EMS, said. The hospital also has a partnership with Eastern State Hospital that could typically move patients within about 12 hours.

Even with that arrangement, those rooms were routinely full during peak evening hours. Since the EmPATH unit opened, Dr. Reid said, it’s now rare for more than one or two patients to need those secured rooms at once, freeing space for other ED patients.

The timeline for behavioral health patients has also shortened: Providers can typically connect with the EmPATH team within about 30 minutes of finishing an ED evaluation, he said. Patients now often receive definitive care within an hour and a half to two hours of arrival — down from a typical three to four hours, and sometimes as long as eight to 10 hours, before the unit existed.

The change required upfront work, Dr. Reid said, including training EMS partners to manage behavioral health patients in transit and coaching ED staff on how to talk with patients about being transported to a separate facility without adding to their anxiety.

He also linked the model to less strain on ED staff.

“We often talk about the moral injury that leads to burnout in the emergency department, where we are trying to do the correct things for patients, but the system logistics around it make it difficult,” Dr. Reid said, adding that the EmPATH unit “is a great way to circumvent that.” He pointed to decreased use of restraints, sedatives and sitters as further evidence the model improved care rather than simply speeding it up. “It’s very satisfying to get these patients the care that they need,” he said.

Dr. Reid said other ED leaders considering a similar model should expect it to require sustained collaboration across disciplines, including standing meetings that bring together community-based providers, hospital staff and outpatient follow-up teams.

“It takes a lot of collaboration and communication,” he said, “but it really has had a great payoff.”

When local health facilities, clinicians, and ancillary resources talk, good things happen. Respect is essential. Being owned by the same mother ship is not.

Big Health defines continuity of care as "a patient receiving consistent and coordinated medical attention throughout their healthcare journey, ensuring that all healthcare providers work together to support the patient's needs. This approach helps improve health outcomes and patient satisfaction by providing a seamless experience across different stages of care."

https://www.beckersbehavioralhealth.com/care-coordination/henry-ford-behavioral-health-pilot-sees-up-to-85-drop-in-work-queues-after-1-year/

Henry Ford behavioral health pilot sees up to 85% drop in work queues after 1 year

Ella Ruder    |    August 11, 2026

Detroit-based Henry Ford Health’s Same-Day Solutions Ambulatory Pilot Program increased the number of patients who completed a behavioral health appointment after being referred for care by 50% at pilot sites.

The program, launched in July 2025, connects patients who express mental health concerns during a primary care visit with a licensed behavioral health provider for an assessment and guidance to the appropriate level of care, according to an Aug. 10 news release from the system.

One year after its launch, the program is deployed in 14 Henry Ford Health primary care clinics across Metro Detroit. Behavioral health referrals increased by 22% over the last year, while the number of patients waiting to be scheduled declined across Henry Ford Health’s behavioral health services by up to 85%. Referrals to specialty services that were not the right fit declined by 76%.

“Instead of asking patients to fit themselves into a particular service, Same-Day Solutions allows us to understand what they need first and build the path from there. That is what a more responsive behavioral health system should look like,” Michael Burton, director of Behavioral Health Integration at Henry Ford Health, said in the release.

Communication, communication, communication.

Alternatives to psychiatric residential placement include Partial Hospitalization Programs (PHP), Intensive Outpatient Programs (IOP), and outpatient care, which allow for varying levels of support while enabling the child to remain at home. These alternatives can provide structured treatment without the need for full residential care.

https://www.beckersbehavioralhealth.com/care-coordination/nevada-cuts-psychiatric-residential-placements-for-children-from-35-to-16/

Nevada cuts psychiatric residential placements for children from 35% to 16%

Ella Ruder    |    August 14, 2026

Nevada reduced the percentage of children with behavioral health disabilities placed in psychiatric residential treatment facilities from 35% to 16% since January 2025, The Nevada Independent reported Aug. 13.

The decline comes as the state works to comply with a five-year settlement agreement with the Department of Justice, signed Jan. 2, 2025, after findings that Nevada violated the Americans with Disabilities Act. The state has also invested more than $100 million in children’s behavioral healthcare through Nevada Medicaid.

Here are five things to know:

1. Among youth covered by Nevada Medicaid who are tied to the settlement agreement, 404 youth out of a population of 1,147 were placed in psychiatric residential treatment facilities at 35%, compared with 382 youth out of a population of 2,408 at 16%.

2. In fiscal year 2020, more than 1,700 Nevada children were admitted to psychiatric hospitals and more than 480 children were admitted to psychiatric residential treatment facilities. Children remained in those facilities for an average of nine to 12 months, with about 27% staying more than a year.

3. Nevada is launching a short-term therapeutic home model intended to provide an intermediate, community-based residential treatment option. The goal is for stays to last between one and three months.

4. The state has invested more than $100 million in children’s behavioral healthcare through Nevada Medicaid. The funding will help raise reimbursement rates for rural and in-home therapy services, specialized foster care services and residential psychiatric treatment for children with complex needs.

5. Ann Jensen, administrator of Nevada Medicaid, said a day at a psychiatric residential treatment facility costs the state between $800 to $950 per child. Ms. Jensen said inpatient care for children is more expensive than offering community-based outpatient services.

https://www.regulations.gov/docket/FDA-2026-N-7874

Deadline Oct. 19.

Off hand, not having read the FDA discussion paper as yet, some questions for your consideration:

• Will I have access to my personal health information?
• Who else will have access, and will they be able to use it without my knowledge or against my wishes?
• Do I trust FDA regulations to protect me?
• When Big Data helps write the FDA regulations (as only they have the expertise to do), will they serve me or their own interests?
• Am I better off with start-ups being completely free to innovate in health AI, including potential ways to protect my health data?

MedTech Intelligence is an online journal & newsletter providing insight & expert opinions on regulatory compliance, QA, product development & market access.

https://medtechintelligence.com/feature_article/fda-seeks-public-feedback-to-inform-regulatory-approach-for-generative-ai-enabled-medical-devices/

FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices

August 18, 2026

GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.

The U.S. Food and Drug Administration today issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enabled medical devices, seeking feedback from interested parties on risk assessment, premarket evaluation, postmarket monitoring, and other topics relevant to the regulation of GenAI-enabled medical devices.

“Artificial intelligence is transforming medicine, and the United States must lead in shaping how this technology is developed and used safely and responsibly,” said Acting FDA Commissioner Kyle Diamantas, J.D. “Today’s announcement reflects the FDA’s commitment to advancing innovation for health care professionals and leveraging AI to improve care and patient health outcomes.”

The Digital Health Center of Excellence (DHCoE), within the FDA’s Center for Devices and Radiological Health, is leading this discussion paper which supports the FDA’s Public Health Pillar on Innovation and Global Leadership. This strategic pillar includes key priorities to advance regulatory frameworks for AI and digital health technologies.

“Patients and clinicians deserve a regulatory approach that keeps pace with the rapid innovation of digital health technologies,” said FDA Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “By inviting input from the public, we are launching a transparent process to inform the development of an approach that safeguards patients and consumers, advances innovation, and serves as a potential model for regulators around the world.”

GenAI-enabled medical devices hold transformative promise for patient care and the broader health ecosystem. At the same time, these devices may introduce unique risks when compared to traditional software and AI-enabled medical devices.

“Generative AI-enabled medical devices are poised to reshape the health technology landscape, and the FDA has an important responsibility to provide thoughtful leadership for this new era,” said DHCoE Director Rick Abramson, M.D. “This discussion paper advances the frontiers of regulatory science and propels a critical conversation about how to enable beneficial innovation, protect public health, and preserve trust.”

The discussion paper begins by outlining a possible two-axis framework for risk assessment that might be used to inform regulatory expectations. It then discusses a potential approach to premarket evaluation built on the concept of competency assessment, inspired at a high level by how physicians are trained and evaluated, consisting of non-clinical device benchmarking and clinical confirmation to evaluate whether a GenAI-enabled medical device performs as intended before reaching patients. The paper also describes several potential approaches to risk-proportionate postmarket monitoring and discusses considerations around foundation models and agentic AI systems. For each of these areas, the FDA poses targeted questions to inform the development of a regulatory framework that is scientifically rigorous, prioritizes patient safety, and aligns with the novel capabilities of GenAI-enabled medical devices.

The FDA encourages feedback on the discussion paper from device manufacturers, clinicians, consumers, researchers, the public, and other interested parties, to be submitted under the docket FDA-2026-N-7874 on Regulations.gov by October 19, 2026.

The discussion paper supports the FDA’s efforts to advance health care by fostering the responsible innovation of safe, effective, and high-quality digital health technologies.