Supreme Court Finds Challengers Do Not Have Standing To Challenge the Legality of Mifepristone

On June 13, 2024, after over a year and a half of litigation, the United States Supreme Court issued an opinion in the mifepristone case. The Supreme Court held (9-0 with Justice Thomas writing a concurring opinion) that the plaintiffs in the case, four pro-life medical associations and several individual doctors, lacked Article III standing to challenge the Food and Drug Administration’s (“FDA”) approval and regulation of mifepristone. As Justice Kavanaugh wrote for the Court: “Under Article III of the Constitution, a plaintiff’s desire to make a drug less available for others does not establish standing to sue. Nor do the plaintiffs’ other standing theories suffice. Therefore, the plaintiffs lack standing to challenge the FDA’s actions.”

History of Mifepristone

As discussed in a prior advisory, the FDA first approved mifepristone for medical termination of pregnancy, up to seven weeks gestation, in 2000. In 2016, the FDA (1) extended the use of mifepristone for up to ten weeks; (2) eliminated the requirement for prescribers to report all non-fatal adverse events; (3) reduced the number of in-person clinic visits from three to one; and (4) allowed healthcare providers other than physicians to dispense mifepristone. The FDA also approved a generic version of mifepristone to GenBioPro, Inc. in 2019. In 2021, the FDA suspended the in-person dispensing requirement for mifepristone during the COVID-19 public health emergency, allowing it to be dispensed through the mail or a through a mail-order pharmacy.

As previously detailed, this case first arose in November 2022 when a group of doctors and medical associations sued the FDA, the Department of Health and Human Services, and several agency heads in their official capacities, seeking to withdraw the FDA’s approval of mifepristone. The United States District Court for the Northern District of Texas, Amarillo Division, agreed with the plaintiffs and stayed the FDA’s 2000 approval of mifepristone and all subsequent agency actions stemming from that approval, but delayed the applicability of its order to allow the federal government time to seek emergency relief from the United States Court of Appeals for the Fifth Circuit. Mem. Op & Order, Alliance for Hippocratic Medicine et al. v. U.S. Food and Drug Administration et al., No. 2:22-CV-00223 (N.D. Tex. Apr. 7, 2023).

Following this opinion, the government sought emergency relief from the Fifth Circuit. The Fifth Circuit issued an unpublished order ruling that the FDA’s 2000 approval of mifepristone could stand but holding that the plaintiffs could challenge FDA actions that began in 2016 to lift restrictions and make it easier for patients to obtain mifepristone. The Fifth Circuit held that its ruling would stand until the case could be heard on the merits and expedited the case to the next available oral argument calendar. Order, Alliance for Hippocratic Medicine et al. v. U.S. Food and Drug Administration et al., No. 23-10362 (5th Cir. Apr. 12, 2023). Following this ruling, the Justice Department, on behalf of the FDA, sought emergency relief from the United States Supreme Court.

Danco, the manufacturer of mifepristone, also sought a stay, which was granted by the United States Supreme Court on April 21, 2023. The effect of the stay was to maintain nationwide access to mifepristone, as it was before the District Court order, ending disposition of the appeal in the United States Court of Appeals for the Fifth Circuit and disposition of a petition for a writ of certiorari to the Supreme Court. Order, U.S. Food and Drug Administration et al. v. Alliance for Hippocratic Medicine et al., No. 22A902 (U.S. Apr. 21, 2023).

A few months later, the Fifth Circuit issued its opinion on the merits of the District Court’s order. Order, Alliance for Hippocratic Medicine et al. v. U.S. Food and Drug Administration et al., No. 23-10362 (5th Cir. Aug. 16, 2023). The Fifth Circuit found that plaintiffs satisfied the requirements for a stay of the FDA’s 2016 and 2021 actions. However, due to the Supreme Court’s prior order, this stay did not go into effect. Rather, the Supreme Court granted certiorari with respect to the 2016 and 2021 FDA actions held unlawful by the Fifth Circuit.

The Supreme Court heard oral arguments in the matter on March 26, 2024. On June 13, 2024, the Supreme Court issued its opinion holding that plaintiffs did not have standing, reversing the judgment of the U.S. Court of Appeals for the Fifth Circuit, and remanding the case for further proceedings.

The threshold question at issue in this case was whether the plaintiffs had standing to sue under Article III of the Constitution. For a plaintiff to have standing, they must have a “personal stake” in the dispute; they cannot be a mere bystander. This means that a plaintiff must demonstrate that (i) they have suffered or are likely to suffer an injury in fact, (ii) the injury likely was caused or will be caused by the defendant, and (iii) the injury likely would be redressed by the requested judicial relief. Disputes regarding standing generally center around two issues: injury in fact and causation.

“An injury in fact must be ‘concrete,’ meaning that it must be real and not abstract.” Such an injury must also be “particularized” meaning that “the injury must affect ‘the plaintiff in a personal and individual way’ and not be a generalized grievance.” Requiring plaintiffs to show an injury in fact is intended to “screen[] out plaintiffs who might have only a general legal, moral, ideological, or policy objection to a particular government action.”

Causation requires the plaintiff to “establish that the plaintiff’s injury likely was caused or likely will be caused by the defendant’s conduct.” When a plaintiff challenges the government’s regulation, or lack thereof, of other individuals, standing is “ordinarily substantially more difficult to establish.” This is usually because it is more difficult for unregulated parties to link their asserted injuries to the government’s regulation, or lack of regulation, or someone else.

Plaintiffs in this case offered several theories to connect the FDA’s actions to plaintiff’s alleged injuries in fact, none of which the Supreme Court found sufficient to establish standing.

One standing theory advanced by the plaintiffs was that the FDA’s relaxed regulation of mifepristone causes them conscience injuries. Specifically, the plaintiffs contended that the “FDA’s 2016 and 2021 actions will cause more pregnant women to suffer complications from mifepristone, and those women in turn will need more emergency abortions by doctors.” Thus, plaintiffs asserted that “they therefore may be required—against their consciences—to render emergency treatment completing the abortions or providing other abortion-related treatment.”

The Supreme Court rejected this argument noting that even if it were true that the FDA’s 2016 and 2021 changes caused more women to require emergency abortions and that some women might seek treatment from plaintiffs that “the plaintiff doctors have not shown that they could be forced to participate in an abortion or provide abortion-related medical treatment over their conscience objections,” as federal conscience laws protect doctors from being required to perform abortions. The fact that federal law protects doctors from being required to perform abortions “therefore breaks any chain of causation between the FDA’s relaxed regulation of mifepristone and any asserted conscience injuries to the doctors.”

Plaintiffs also alleged monetary and related injuries due to the FDA’s actions. In particular, “diverting resources and time from other patients to treat patients with mifepristone complications; increasing risk of liability suits from treating those patients; and potentially increasing insurance costs.” The Supreme Court found that such claims lacked support in the record and were “highly speculative.” Furthermore, the Court noted that “the law has never permitted doctors to challenge the government’s loosening of general public safety requirements simply because more individuals might show up at emergency rooms or in doctor’s offices with follow-on injuries.” In other words, “there is no Article III doctrine of ‘doctor standing’ that allows doctors to challenge general government safety regulations” and the Court declined to create such a doctrine.

Lastly, the plaintiff medical associations argued that they had organization standing “to sue on their own behalf for injuries they have sustained” and that “the FDA has ‘impaired’ their ‘ability to provide services and achieve their organizational missions.’” Here, the Court concluded that the medical associations could not establish standing based simply on their interests and strong opposition to the FDA’s conduct. The medical organizations asserted that they showed more than a disagreement with the FDA, but that the FDA caused them to incur costs to oppose the FDA’s actions, such as conducting their own studies on mifepristone and exerting time, energy, and resources into drafting petitions and engaging in advocacy. However, the Court rejected this argument as well noting that “an organization that has not suffered a concrete injury caused by a defendant’s action cannot simply spend its way into standing simply by expending money to gather information and advocate against the defendant’s action.”

While the plaintiffs also suggested that they must have standing because if they do not, then no one would have standing to challenge the FDA’s 2016 and 2021 actions, the Supreme Court concluded that it was not clear no one else would have standing and that, even if this were the case, the “Court has long rejected that kind of ‘if not us, who?’ argument as a basis for standing.”

In conclusion, the Supreme Court’s opinion found that the plaintiffs did not have standing but did not address the merits of the case. Thus, while mifepristone currently remains available under the same terms as it did before this litigation, this case remains ongoing and other cases challenging mifepristone are expected.


via Hancock Daniel

Our team is continuing to monitor post-Dobbs developments on all fronts, including any changes around the regulations regarding mifepristone. For questions regarding any post-Dobbs issues, please contact any of the following Hancock, Daniel & Johnson attorneys: Ashley CalkinsAnnie HowardSandi Douglas, or Mary Malone.

Click here for a full PDF version of the advisory.

The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel & Johnson, P.C., is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel & Johnson, P.C. be liable for any direct, indirect, or consequential damages resulting from the use of this material.

Quick Fit List: 5 Hacks To Squeeze Exercise into Everyday Life

As a physician, you already know fitness is a critical component of total health that also has a major impact on reducing disease and other health risks. And you know exercise plays a key role in improving mental health. But knowing isn’t the same as doing.

Are physicians and PAs focusing on fitness?

Like patients, physicians and PAs struggle to find time to fit fitness into lives crammed with professional demands, personal responsibilities, and ever-growing to-do lists. In your practice, you have undoubtedly shared fitness advice — like taking the stairs, or parking farther away from the store or office — with your patients to help them get more exercise in their day. Are you following your own advice?

In recognition of National Physical Fitness and Sports Month, we’ve put together a Quick Fit List, 5 “hacks” to squeeze exercise into everyday life. Use the list to help you — and your patients — find more ways to make time for exercise, without making major changes that may just be unrealistic right now.

Quick Fit List: Hacks to Squeeze Exercise into Everyday Life

When it comes to exercise, something is always better than nothing, right? As far as a rigorous exercise regimen is concerned, it’s just not possible for everyone — so “imperfect” is also better than “perfect.” As you know, the keys to fitness success are consistency and effort. Our Quick Fit List features 5 quick and easy ways to make exercise part of everyday life and is a great place to start making the effort and being more consistent about focusing on fitness.

  1. TRY 4 SECONDS. If you sit most of the day, breaking up sitting with short bursts of intense exercise several times a day can undo some of the adverse effects of being sedentary. Just 4 seconds of intense exercise multiple times a day can help. So, every time you stand up to stretch, get coffee, see a patient, or go to a meeting, try adding a quick burst of exercise. Jumping jacks are a good option. Too easy? Try plank jacks. Read the study here.
  2. FIND 3 MINUTES. What if you extend your 4-second burst into a 1-minute burst? It will also add up. Just a 1-minute burst of movement three times a day has been shown to make a meaningful health difference. And it doesn’t even have to be “exercise.” So don’t just walk up the stairs to your office, run up them. Sprint to your car in that farthest-away parking spot. Or carry your groceries to the car instead of using a cart. Read the study here.
  3. LAUNCH A NEW TINY HABIT. In his book “Tiny Habits: The Small Changes That Change Everything,” author BJ Fogg, PhD recommends tying new habits to existing habits, or “anchor moments,” to give the new habit a better chance of sticking. The hack here: Connect exercise to something you already do. Like counter pushups while you wait for your Keurig to brew. Or holding a deep squat while you brush your teeth. Or balancing on one foot while you supervise the kids in the tub. Here’s another idea: Try a few minutes of chair yoga or other seated exercises from your comfy couch for the first few minutes every time you sit down to watch TV for the night.
  4. UP-LEVEL YOUR WALK. If you’re already walking, good for you! Take it up a notch. Add a weighted vest to boost intensity, which doesn’t strain ankles and shoulders like hand or ankle weights can. Increase your speed for the duration of your walk. Or add bursts of increased speed or even short intervals of running to your walk. If you walk outside, seek some hills. If you walk on a treadmill, increase your incline.
  5. MAKE IT SOCIAL. Most of us prefer spending time with friends and family over getting a workout in. And many of us make time for getting together — but not for exercise. You can do both! Get moving with your people. Add movement to the time you already spend together. Instead of a date night dinner out, do something active like dancing. Instead of meeting friends for drinks to catch up, meet up and go for a hike. The same can work for your monthly book club, try kicking it off with a 10-minute walk. Got kids? Replace some screen time with a couple of minutes of yoga during their weekend morning routine — and yours. The card deck Yoga Pretzels is a fun place to find ideas.

When it comes to finding time for fitness, it’s OK to start small. Just start!

Highly Pathogenic Avian Influenza Update for Virginia

via VDH


Dear Colleague:

On April 1, 2024, Texas reported, and CDC confirmed, that a person in the United States tested positive for highly pathogenic avian influenza (HPAI) A(H5N1) virus after exposure to infected dairy cattle. The patient reported eye redness, consistent with conjunctivitis, as their only symptom. In light of this, VDH is asking clinicians to maintain a low threshold for H5N1 testing if a patient presents with any relevant symptom(s) and exposure history. To date, HPAI A(H5N1) virus has not been detected in people, dairy cattle, or other domestic animals in Virginia.

According to CDC, the current risk of H5N1 bird flu infections in people remains low. There is no current evidence of human-to-human HPAI A(H5N1) transmission. However, people with exposure to infected birds, cattle, or other animals are at higher risk and should take appropriate precautionsGenetic analyses of the virus from the Texas patient show no evidence of increased transmission risk or antiviral drug resistance. Two H5N1 candidate vaccines are available if the human health risk assessment changes and vaccines are needed.

VDH is recommending that clinicians have a low threshold to request H5N1 testing in any person showing signs or symptoms of acute respiratory illness (including conjunctivitis) who has a relevant exposure history to cattle, unpasteurized (raw) milk, birds, other animals, or their feces, including exposure to animals with no apparent signs of infection. If an H5N1 bird flu infection is suspected, please immediately notify your local health department, who can coordinate testing with the Virginia Division of Consolidated Laboratory Services (DCLS). Specimen collection guidance can be found on the DCLS website.

The following is recommended for any person with signs and symptoms compatible with avian influenza A(H5N1):

  1. Isolate the patient and follow infection control recommendations, including using PPE.
  2. Initiate empiric antiviral treatment as soon as possible. Do not delay treatment while awaiting laboratory results.
  3. Notify your local health department immediately to arrange testing for influenza A(H5N1) virus.
  4. Collect specimens from the patient to test for influenza A(H5N1) virus at the state health department laboratory.
    1. Patient with respiratory symptoms: collect one nasopharyngeal (NP) swab AND one combined nasopharyngeal/oropharyngeal (NP/OP) swab
    2. Patient with conjunctivitis symptoms (with or without respiratory symptoms): collect one NP swab AND one conjunctival swab
  5. Encourage patients to isolate at home away from their household members and not go to work or school until it is determined whether they have avian influenza A(H5N1) virus infection.

VDH is coordinating closely with the Virginia Department of Agriculture and Consumer Services (VDACS) and will ensure that local public health officials, the public, and healthcare providers have up to date information on this situation as it evolves.

Thank you again for your continued partnership in keeping Virginians safe from all respiratory illnesses. To learn more about H5N1 bird flu, please visit the following websites:

Sincerely,

Karen Shelton, MD
State Health Commissioner

How PMHCA and HHS are improving access to tele-behavioral health services

Two new telehealth.hhs.gov videos, featuring the Virginia Mental Health Access Program (VMAP), are now available for viewing. In these short clips, learn how providers can use telehealth to improve access to mental health care for their pediatric patients.

These telehealth videos, as well as other Pediatric Mental Health Care Access Program (PMHCA) Awardee Videos, can be accessed here. PMHCA thanks Dr. Sandy Chung and the amazing VMAP team members for their participation!

 

 

Reporting Adverse Events in Children Following Exposure to THC and CBD Containing Products

Dear Colleague:

Since November 2022, the Virginia Department of Health (VDH) has received some reports of adverse events in children who consumed products containing tetrahydrocannabinol (THC) or cannabidiol (CBD).  Reported symptoms for these adverse events have included vomiting, hallucinations, low blood pressure, low blood sugar, altered mental status and anxiety; some hospitalizations have occurred.

In response to these reports, VDH has established a special surveillance system to better characterize the burden and impact of adverse events due to THC and CBD consumption on children in the Commonwealth. The surveillance is being conducted in accordance with authority outlined in the Virginia Regulations for Disease Reporting and Control, 12 VAC 5-90-80, Section H. We ask providers to immediately report to their local health department:

  • Adverse events requiring hospitalization in children less than 18 years of age following exposure to a THC or CBD product; and
  • Clusters of adverse events in children less than 18 years of age following exposure to a THC or CBD product.

Providers should report to VDH through the THC and CBD Adverse Events Reporting Portal, or to the local health department by the most rapid means available, preferably by telephone. After a hospitalization or cluster is reported, VDH staff will collect information about the illness(es), possible exposures, and laboratory results. Public health testing through the Division of Consolidated Laboratory Services (DCLS) can be requested to support patient or product testing; however, advance approval through your local health department is required.

Thank you for your partnership and cooperation.

Sincerely,

Karen Shelton, MD
State Health Commissioner

AMA Update on Change Healthcare Cyberattack

UnitedHealth Group (UHG) issued a press release on Monday, April 22, with more information about the Change Healthcare cyberattack and the impact of the breach on personal data. UnitedHealth Group officials have agreed to address any additional questions. Please review the press release and send any questions you may have to [email protected].

UHG’s press release stated that its preliminary findings from the ongoing investigation and review of the data involved in the cyberattack consist of the following:

  1. Based on sampling of their data, files containing protected health information (PHI) or personally identifiable information (PII) were involved in the breach.
  2. This information could cover a substantial proportion of people in America.
  3. UHG has not seen evidence of exfiltration of materials such as doctors’ charts or full medical histories among the data involved in the breach.
  4. It continues to monitor the internet and dark web to determine if data has been published.
  5. There were 22 screenshots, allegedly from exfiltrated files, some containing PHI and PII, posted for about a week on the dark web by a malicious threat actor.
  6. UHG offered to make notifications and undertake related administrative requirements on behalf of any provider or customer to help ease the reporting obligations on other stakeholders whose data may have been compromised.

UHG also posted about the “strong progress” that Change Healthcare is making to restore services, but we know that many practices are still facing major financial and administrative challenges due to the cyberattack. The AMA has developed another brief survey to gather up-to-date information on the impact of the breach on physicians and practices to inform our policy discussions with UnitedHealth Group, the Biden administration, and Congress. Survey responses are due Wednesday, April 24.

As UHG’s investigation proceeds to determine the scope and extent of the compromised information and the impacted customers and individuals, it created a dedicated website (changecybersupport.com) and call center (866.262.5342) to provide more information and resources, including free credit monitoring and identity theft protections for two years to anyone impacted. UHG expects more information and announcements to be forthcoming as its investigation continues, including an official notification of a breach.

For more information on UHG’s funding assistance program, please visit Temporary Funding Assistance for Providers. The CMS Change Healthcare/Optum Payment Disruption (CHOPD) program is available online. The AMA will continue to raise issues of concern to UHG, CMS, state regulators, and other payers. Additional information from the AMA is also available on our Change Healthcare cyber outage webpage.

Do you know these 10 influential women in medicine?

From pioneers to innovators to inventors, do you know these 10 influential women in medicine? Take our Women’s History Month quiz! Hint: many are from Virginia or have Virginia connections.


1. This Virginia woman is a physician-scientist and pathologist known for her advocacy of women’s health issues, particularly for ensuring federally funded medical studies include female patients. Born in Halifax, she attended segregated schools in Lynchburg. She earned her medical degree from the University of Virginia School of Medicine in 1967, and was the only woman and only African-American in her class. In 1991 she became the first director of the new Office of Research on Women’s Health at the National Institutes of Health (NIH) and first permanent NIH associate director of research on Women’s Health. 

Expand for Question 1 Answer

Vivian W. Pinn, MD – About


2. In 1864 this former nurse became the first African-American woman to be granted an MD degree in the United States. She was the only Black graduate of the New England Female Medical College in Boston, before it merged with Boston University School of Medicine in 1873. She also wrote one of the first medical publications by an African-American: “Book of Medical Discourses.” Virginia connection: After the Civil War, she moved to Richmond to care for freed slaves before returning to her home in Boston.

Expand for Question 2 Answer

Rebecca Lee Crumpler, MD – About


3. In 1953 this woman created the first tool to scientifically assess a neonate’s health risks and need for potentially life-saving observation. She was only the second woman in the United States to become Board certified in anesthesiology by the American Society of Anesthesiologists, which she achieved in 1939, and 10 years later was named the first woman full professor when Columbia University’s College of Physicians and Surgeons launched an academic department of anesthesia research. She later became an influential advocate for the March of Dimes.

Expand for Question 3 Answer

Virginia Apgar, MD (Apgar score) – About


4. In 1893 this Virginia woman was the first African-American woman to receive a certificate from the Virginia State Medical Examining Board. She graduated from Richmond Colored Normal School and Howard University Medical College. During the 1890s she was one of only three female physicians and about a half-dozen African-American physicians in Richmond. She and her physician husband helped create a medical society for African-American doctors in 1902, and the following year she helped open a hospital for Black patients and training school for nurses, later named in her honor — which years after became Richmond Community Hospital.

Expand for Question 4 Answer

Sarah Garland Boyd Jones, MD – About


5. In 1889 this woman became the first Native American woman to be granted an MD degree in the United States. She was the youngest daughter of the last recognized chief of the Omaha. She graduated from the Woman’s Medical College of Pennsylvania at the top of her class. She returned to the Omaha reservation in Nebraska where she practiced medicine and became known as a devoted public health advocate and civil rights activist. Virginia connection: She attended college at Hampton Institute, now Hampton University, and was salutatorian in 1886.

Expand for Question 5 Answer

Susan LaFlesche Picotte, MD – About


6. This woman successfully mapped the brain’s prefrontal and frontal cortices — research which has allowed for better understanding of diseases such as schizophrenia, dementia, cerebral palsy, Parkinson’s disease, and Alzheimer’s disease. Trained as a psychologist, she became one of the most innovative and sophisticated neuroscientists in the modern era of brain exploration. Over her career she published more than 200 papers and received numerous honors, including admission to the National Academy of Sciences in 1990.

Expand for Question 6 Answer

Patricia Goldman-Rakic, MD – About


7. In 1849 this woman became the first to be granted an MD degree in the United States. She was rejected by more than 10 medical schools, and refused the suggestion to disguise herself as a man to gain admission. She attended and got her degree from the Geneva Medical College in western New York. In 1857 she was a founder of the New York Infirmary for Women and Children, which supported medical education for women who were often rejected from internships elsewhere at the time.

Expand for Question 7 Answer

Elizabeth Blackwell, MD – About


8. This Virginia woman pioneered the first electric device for feeding amputees, part of which was patented in 1948. As a child she attended Diggs Chapel in Hickory, a one-room schoolhouse built after the Civil War to educate former slaves, their children, and Native Americans. There she learned to become ambidextrous after being reprimanded for writing with her left hand. She also taught herself to write with her teeth and feet, skills useful for her career as a nurse and physical therapist working with amputee veterans. She also invented a neck frame that holds a bowl or cup close a patient’s face, and a disposable emesis basin.

Expand for Question 8 Answer

Bessie Blount Griffin – About


9. In 1990 this woman became the first woman and the first Hispanic to become Surgeon General of the United States. Her appointment followed nearly two decades of public service at the National Institutes of Health where she drafted national legislation on organ transplantation. While at the University of Michigan, where she completed her medical training in nephrology, she was the first woman to be named Intern of the Year. As Surgeon General she is known for her campaign against the tobacco industry advertising aimed at children, alerting the nation to the rise of AIDS among women and adolescents, and expediting FDA approval of vaccines for military personnel during the Gulf War — for which she was awarded the Legion of Merit military honor.

Expand for Question 9 Answer

Antonia Novello, MD – About


10. This Virginia woman was a reproductive endocrinologist who pioneered in vitro fertilization in the United States, among other fertility-related advances. In 1949 she made the first description of Luteal Phase Dysfunction and is credited among the first to use progesterone to treat women with a history of miscarriages, allowing many women to conceive and deliver healthy babies. In 1978 she and her physician husband moved to Norfolk to create an IVF program at Eastern Virginia Medical School. On December 28, 1981, their procedure gave birth to the first American test tube baby, and 15th in the world.

Expand for Question 10 Answer

Georgeanna Seegar Jones, MD – About


Bonus: From #10 above, do you know the name of the first American test tube baby, who was delivered at Norfolk General Hospital? She was invited to the 2024 State of the Union Address by U.S. Senator Tim Kaine.

Expand for Bonus Answer

Elizabeth Jordan Carr

SafeHaven Fatigue and Wellness Program expanded again in Virginia

The Virginia General Assembly has passed two identical bills in the 2024 session to:

  1. Expand access to the SafeHaven program to dentists and dental hygienists
  2. Authorize the SafeHaven program to provide outpatient health care to health care professionals
  3. Encourage health care professionals to voluntarily seek behavioral health services without fear of mandatory reports to health regulatory boards in every circumstance

In 2020, Virginia became the first state in the nation to enact statutory protections to enable health care professionals to seek assistance for fatigue, wellness, and burnout without fear of licensure or liability repercussions for doing so. The initiative was launched by the Medical Society of Virginia and the program established pursuant to the statutory framework was branded and trademarked as “SafeHaven.” SafeHaven is voluntary, and enrollment may be by individual, by group or by employer. A tip of the hat is due to the Virginia Trial Lawyers Association (“VTLA”) for working with the Medical Society of Virginia on crafting the initial SafeHaven legislation and all subsequent expansions. Without the collaboration and cooperation of the VTLA, the pathway to achieve SafeHaven would have been extremely challenging.

In the years that followed the initial passage of the law, two trends developed. First, medical societies and associations in other states sought guidance and direction from the Medical Society of Virginia on how to introduce and secure passage of legislation to create similar protections with the goal of encouraging health care professionals to seek help and to take steps to preserve wellness. Secondly, the Medical Society of Virginia sought additional statutory protections to expand which health care professionals are eligible to avail themselves of the SafeHaven program.

The initial legislation in 2020 enabled any professional licensed, registered or certified by the Board of Medicine to participate in SafeHaven. Since 2020 and almost on an annual basis, favorable amendments to Virginia Code Section 8.01-581.16 were achieved to enable any person licensed by the Boards of Medicine, Nursing, and Pharmacy to enroll in SafeHaven along with any student enrolled in a school of medicine, osteopathic medicine, nursing, or pharmacy located in the Commonwealth.

In the 2024 session of the Virginia General Assembly, Senator Todd Pillion (R, Abingdon) and Delegate Patrick Hope (D, Arlington) introduced Senate Bill 629 and House Bill 42, respectively. These bills represented key priority legislative issues for the Medical Society of Virginia and the Virginia Dental Association. Both bills are identical and passed both the House of Delegates and the Senate of Virginia without a single vote in opposition.

The 2024 legislation accomplishes three goals. First, it expands the types of health care providers who can avail themselves of the SafeHaven program to include any person registered, certified or licensed by the Board of Dentistry, together with any student of a dental school or school of dental hygiene in the Commonwealth. The rational for this addition stemmed from the significant prevalence of suicide and behavioral health needs of dental professionals. In fact, the American Dental Association reported in February of 2022 from their “2021 Dentist Well-Being Survey” that depression and anxiety disorders are higher among dentists than the general population.

Next, the scope of services that may be provided by the SafeHaven program was expanded to include the “arranging for [or provision of] outpatient health care related to career fatigue and wellness for health care professionals….” The rationale for this expansion stemmed from health care work force shortages and lack of timely access. For example, professionals served by SafeHaven often need prompt outpatient medical or behavioral health treatment. Securing appointments or providing services are often challenging. By enabling SafeHaven to schedule appointments or directly provide outpatient health care services, it greatly enhances achieving successful outcomes. “Health care” is defined in Virginia Code Section 8.01-581.1 to include many services and care, including medical, pharmacy and behavioral health. For example, if a professional in the SafeHaven program needed a psychiatric or psychological consultation, the SafeHaven program could arrange for the consultation or provide the consultation. If a professional is in need of a prescription for a behavioral health drug, it can be more timely obtained to provide more timely therapeutic results.

Finally, the legislation clarifies when mandatory reports are required to be made to health regulatory boards by Chief Executive Officers (CEO) or Chiefs of Staff (COS) for all hospitals pursuant to Virginia Code Section 54.1-2400.6. The current statute provides two reporting deadlines. First, if a professional is involuntarily admitted (temporary detention order) then a report must be made to the pertinent health regulatory board in five days. There is little ambiguity regarding that reporting provision.

The second reporting requirement in the statute centered on making a report to the pertinent health regulatory board when the CEO or COS was not clear on whether professionals who are in need of treatment or are voluntarily admitted must be reported to their respective health regulatory board within 30 days. For example, if a professional voluntarily seeks treatment or is admitted to a facility, is a report required within 30 days if the professional stabilizes and is no longer a threat to themselves or the public? This ambiguity resulted in inconsistent interpretations by facilities and their leadership.

The new legislation restructures the reporting obligations to better clarify when reports are required. The general rule will be that if a CEO or COS becomes aware in their official capacity that a health professional has been “voluntarily” admitted as a patient for treatment of a substance abuse or psychiatric illness and such illness may continue for more than 30 days after admission, then a report is required. The timing of the report to the health regulatory board is within five days of the conclusion of the 30-day period.

A key and significant exception to a report having to be made was included in the legislation. Specifically, no report has to be made to a health regulatory board if the “physician, physician assistant or nurse practitioner treating the health professional for substance abuse or psychiatric illness provides written confirmation to the entity required to make such report that the health care professional no longer is believed to be a danger to himself, the public or his patients.”

For example, if a physician voluntarily admits to a behavioral health unit for substance abuse or a psychiatric illness the requirement for a “30 day” report to be made is triggered. The reporting entity would be required to make such a report within five days of the conclusion of the 30-day period. However, if the treating physician, physician assistant or nurse practitioner provides written confirmation that the professional is no longer a danger to himself, the public or his patients, then no report is required.

The goal is to encourage providers to voluntarily seek help and assistance. Knowing today that seeking help will likely still result in a report to a health regulatory board is a huge impediment for professionals wanting to get help before they decompensate further. With this statutory revision, a professional can seek voluntary admission, be treated for a few days, a week, or 30 days and so long as the treating physician, physician assistant or nurse practitioner certifies in writing to the CEO or COS that the professional is no longer a danger, no report will be required to the health regulatory board.

While these bills are awaiting signature by Governor Youngkin, it is not too early to launch the education efforts on these changes and encourage those health care professionals who need to plan ahead and enroll in SafeHaven so their wellbeing will remain steadfast and positive.

If you have any questions or need further guidance regarding Virginia’s SafeHaven program, please contact a member of Hancock Daniel’s Government Relations team.

Kaine and Marshall introduce bipartisan resolution recognizing March 18 as Health Workforce Well-being Day of Awareness

WASHINGTON, D.C. – Today, U.S. Senators Tim Kaine (D-VA) and Roger Marshall (R-KS), members of the Senate Health, Education, Labor and Pensions (HELP) Committee, introduced a bipartisan resolution designating March 18, 2024 as Health Workforce Well-Being Day of Awareness. The date was selected to coincide with the day that the senators’ bipartisan Dr. Lorna Breen Health Care Provider Act was signed into law by President Biden in 2022.

“Our health care providers protect our health and well-being every day, often at the expense of their own. My Dr. Lorna Breen Health Care Provider Protection Act is making strides to reduce and prevent suicide, burnout, and mental and behavioral health conditions among health care professionals. I was proud to introduce a bill to reauthorize the law—but there’s more we can do to raise awareness,” said Senator Kaine. “Designating March 18 as Health Workforce Well-Being Day of Awareness would help reduce stigma, advance research, and ensure providers can get the care they need.”

“As a physician myself for over 25 years, I know how dedicated our health care workers are to serving their patients around the clock,” Senator Marshall said. “This job is not easy and requires strenuous hours and hard work, with immense stress and pressure; today, I’m proud to introduce our bipartisan resolution that designates March 18th as the Health Workforce Well-Being Day of Awareness. Honoring, supporting and taking time to recognize the challenges our health care professionals face is critical in providing every patient with excellent care.”

Kaine has long led efforts to protect the mental health and well-being of the health care workforce. Earlier this month, Kaine introduced bipartisan legislation to reauthorize the Dr. Lorna Breen Health Care Provider Protection Act, which has already provided $100 million in funding for mental health care for providers across the country, including $5.6 million in federal funding for Virginia providers at UVA Health, Virginia Commonwealth University, and George Mason University, for five years. Named in honor of Dr. Lorna Breen, a physician from Charlottesville, Virginia who was working on the front lines of the pandemic in New York and died by suicide in the Spring of 2020, the law is helping to address mental health concerns facing our health care providers.

The resolution was cosponsored by Senators Jack Reed (D-RI), Shelley Moore Capito (R-WV), Debbie Stabenow (D-MI), Susan Collins (R-ME), Amy Klobuchar (D-MN), Tina Smith (D-MN), Angus King (I-ME), Mark Warner (D-VA), Krysten Sinema (I-AZ), and Mark Kelly (D-AZ).

“We are deeply thankful to Senators Kaine and Marshall and all supporting organizations for establishing Health Workforce Well-Being Day, coinciding with the anniversary of the Dr. Lorna Breen Health Care Provider Protection Act’s enactment,” said Corey Feist, JD, MBA, co-founder and CEO of the Dr. Lorna Breen Heroes’ Foundation. “Acknowledging the pressures health workers face and making their well-being a priority is essential – and our solutions must move far beyond individual resilience. It is vital that we drive evidence-informed, systems level solutions to reduce and prevent burnout, sustain well-being and build a system where health workers can thrive. This not only benefits the healthcare workforce but also improves patient care and contributes to the overall health of our communities.”

“The Medical Society of Virginia and its program, SafeHaven, stands in support of this resolution. This is important work in destigmatizing mental health and well-being in the healthcare profession. As we are seeing increased provider burnout and many choosing to leave the profession, now is the time to come together and support these professionals who care for us every day. This is another step in the right direction to changing the landscape of healthcare worker mental health,” said Medical Society of Virginia CEO and Executive Vice President, Melina Davis.

“Formal federal acknowledgment of the importance of wellness and well-being among America’s health care professionals has immense value,” said Virginia Hospital & Healthcare Association (VHHA) President and CEO Sean T. Connaughton. “Many health care providers experienced burnout associated with the emotional strain and the physical toll of caring for patients amid the intensity of the COVID-19 pandemic, which also coincided with workforce challenges across the sector. Policies such as the reauthorization of the Dr. Lorna Breen Health Care Provider Protection Act to provide support and dedicated resources for health care professionals, and an official resolution designating March 18 as Health Workforce Well-Being Day of Awareness, speak volumes about the commitment of elected officials to care for the clinicians who offer comfort and medical treatment to countless Americans. We commend Senator Kaine and his colleagues in Congress who have championed these efforts.”

“Senator Kaine’s resolution to designate March 18 as Health Workforce Well-Being Day of Awareness is an important step in bringing attention to issues of health workforce burn out and mental health. The George Mason University College of Public Health and the Center for Health Workforce look forward to working with Senator Kaine and the legislature to address health worker well-being and the critical shortage of health workers in the state,” said Dr. Melissa J. Perry, Dean of George Mason’s College of Public Health.

“The wellbeing of our nation’s health care providers is essential, and I’m proud to support the Health Workforce Well-Being Day of Awareness on March 18,” said Nancy Howell Agee, CEO of Carilion Clinic and past chair of the American Hospital Association. “Thank you to Senators Kaine, Marshall, Reed, Capito, Stabenow, Collins, Klobuchar, Smith, and King for continuing to shine a light on the needs of those who dedicate their lives to caring for their neighbors.”

“As healthcare providers, we’re in the business of taking care of people and that starts with our team members,” said Marlon Levy, M.D., MBA, Interim Senior Vice President, VCU Health Sciences and Interim Chief Executive Officer, VCU Health System. “VCU Health is proud to support Senator Kaine’s and Senator Marshall’s resolution designating March 18 as Health Workforce Well-Being Day of Awareness. Having a healthy, engaged and caring workforce is essential to taking care of our communities.”

“We are grateful to Sen. Kaine for his support for the well-being of healthcare workers through his resolution to create a ‘Health Workforce Well-Being Day of Awareness.’ Promoting wellbeing helps our team members provide high-quality care to patients while working in an often demanding and stressful profession,” said K. Craig Kent, MD, University of Virginia Health CEO.

“It’s impossible to hear stories day in and day out of physical challenge and hardship and emotional trauma without absorbing some of our patients’ pain. Medicine done well involves sympathizing but more importantly empathizing with our patients. Over time, this burden of human suffering can build up. Recognizing the importance of an emotionally healthy workforce helps acknowledge it’s importance. That can then guide the dedication of appropriate time and resources directed toward that goal. We wholeheartedly support the Health Workforce Well-Being Day of Awareness,” said Dr. David Roberts, Chief Medical Officer, Community Health Center of the New River Valley.

A full list of supporting organizations and quotes is available here.

Full text of the resolution is available here.

Mpox, Measles, and Sexually Transmitted Infection Prevention Updates for Virginia

via VDH


Dear Colleague:   

This letter provides updates on mpox, measles, and sexually transmitted infection prevention.  

Increase in Mpox Cases in Virginia

Since November 1, 2023, seven mpox cases have been reported to the Virginia Department of Health (VDH) from the Central, Eastern, Northern, and Northwest regions. Among these seven patients, two were hospitalized, three were coinfected with HIV, and only one had been previously vaccinated. Notably, VDH received four reports of mpox in the first month of 2024; VDH received a total of 12 reports in all of 2023. Small clusters of mpox continue to occur across the country, prompting the Centers for Disease Control and Prevention (CDC) to urge clinicians to remain diligent about taking thorough patient sexual histories and recommending vaccination to those who are eligible. 

These recently reported cases are a good reminder to continue to promote preventive measures, including JYNNEOS vaccination, to help protect against infection and severe illness. We encourage healthcare providers to offer the mpox vaccine to people at increased risk or refer patients to a vaccine site near them (people should get both doses of vaccine for the best protection), consider mpox in their differential diagnoses, test persons with suspected mpox rash, and manage illness with supportive care and antiviral medications, as needed.  

For more information, please refer to the VDH Mpox Webpage for Healthcare Providers and Integrating Mpox into Sexual Health and HIV Care. 

Stay Alert for Measles

VDH advises healthcare providers to stay alert for measles due to a recent increase in global measles cases and a growing global threat from the disease. Twenty-three confirmed cases of measles were reported in the U.S. between December 1, 2023, and January 23, 2024, including two outbreaks with more than five cases each and seven imported cases among international travelers. Most of the people with measles were unvaccinated children and adolescents. Two confirmed cases recently traveled through Virginia in January. Virginia has had one reported measles case to date in 2024 and reported one case in 2023.   

Healthcare providers should be alert for patients with rash illness with fever and other symptoms consistent with measles (cough, coryza, or conjunctivitis) and who have recently traveled internationally, especially to countries with ongoing measles outbreaks. Please notify your local health department of any suspected cases of measles immediately and collect a nasopharyngeal swab (secondary specimen can include oropharyngeal swab and urine) for reverse transcription polymerase chain reaction (RT-PCR), as well as a blood specimen for serology. 

Measles can spread to susceptible U.S. residents after being imported by unvaccinated and under-vaccinated travelers. It is important to ensure all your patients are up to date on measles vaccine, especially before international travel. People aged six months or older who will be traveling internationally should receive a measles-containing vaccine. 

Please visit VDH’s measles website for more information. 

Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infection Prevention

Rates of sexually transmitted infections (STI) have increased significantly in the past several years in Virginia and nationally. Increases in syphilis are of the utmost concern; preliminary data from 2023 show increases in syphilis diagnoses in nearly all Virginia health regions. Because of this, VDH issued clinical considerations for the use of Doxycycline Post-Exposure Prophylaxis (DoxyPEP), accompanied by a fact sheet for patients. Doxycycline administered as 200mg within 24–72 hours of condomless sex has been shown to significantly reduce the acquisition of syphilis, chlamydia, and gonorrhea among men who have sex with men and transgender women. VDH recommends that health care providers consider DoxyPEP in these populations, as clinically appropriate. VDH clinical considerations and fact sheet are aligned with CDC draft guidelines for the use of doxycycline as post-exposure prophylaxis for bacterial STIs. VDH recommendations will be revised as needed to align with the final CDC recommendations once they are released. 

Please visit the VDH syphilis healthcare provider resource page and the VDH STI healthcare professionals resource page for additional information on STI prevention.  

Thank you again for your continued partnership in keeping Virginians safe and healthy. 

Sincerely, 

Karen Shelton, MD 
State Health Commissioner