Melina Davis, CEO of the Medical Society of Virginia, and Ally Jaffee, NHS Psychiatrist, join Dr. Otten to discuss a nationally and internationally growing movement and program: SafeHaven.
Listen now to learn more about the need for confidential support and psychological safety for our healthcare professionals
RICHMOND, VA — Governor Glenn Youngkin today announced additional key administration and board appointments. Congratulations to MSV members for their appointments:
Dr. Michele Nedelka of Virginia Beach
Radiation Oncologist, Bon Secours Mercy Health
Sandy L. Chung, MD, FAAP, FACHE of Fairfax
Founder and Medical Director, Virginia Mental Health Access Program; CEO, Trusted Doctors
Dr. Walter E. Vest III of Virginia Beach
Retired physician
See the full list of new administration and board appointments here.
The Biden administration is proposing a 2.8% decrease to physician payments in its newly released pay proposal for physicians, drawing near-immediate protest from the industry.
Unveiled Wednesday afternoon, the calendar year 2025 Medicare Physician Fee Schedule proposed rule outlines new policies focused on primary care, preserved telehealth flexibilities and a strengthened Medicare Shared Savings Program (MSSP).
However, the release is headlined by a proposal to decrease average base payment rates by 2.93% from calendar year 2024.
That number incorporates statutory requirements that adjustments be “budget neutral,” the expiration of a 2.93% bump included in calendar year 2024 and an adjustment related to the work relative value unit (RVU) portion of certain services, the administration explained in a news release.
Together, this places the proposed rule’s conversion factor—or the number of dollars Medicare pays per RVU—at $32.36—2.8% lower than calendar year 2024’s $33.29.
In statements quickly released after the proposed rule dropped, frustrated physician and industry groups contrasted the “dangerous” baseline reimbursement cut against financial pressures weighing on practices…
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.”
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.
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 Calkins, Annie Howard, Sandi Douglas, or Mary Malone.
Click here for a full PDF version of the advisory.
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.
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.
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.
When it comes to finding time for fitness, it’s OK to start small. Just start!
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 precautions. Genetic 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):
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
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!
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:
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
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:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Elizabeth Jordan Carr
