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06/18/2024

Recent Medical Board & Legal News

 
 

US Supreme Court Decision Keeps Mifepristone Access Status Quo

Last week, the US Supreme Court issued a decision concerning the FDA’s regulation of the medication induced abortion drug Mifepristone. The Court ruled that the Plaintiffs bringing the case against the FDA, which had acted to providing broader access to the drug, did not have standing. The Court dismissed the case allowing the FDA’s broader access regulations to continue.

Background:
In 2016 and 2021, the FDA loosened restrictions on the prescription and use of the medication induced abortion drug Mifepristone. In particular, the changes allowed for a longer time span for use (7 week to 10 weeks of pregnancy) and allowed some non-physicians to prescribe the drug in 2016, while in 2021 the FDA dropped the requirement of an in-person initial visit. In 2022, some medical associations and a few physicians sued the FDA on the loosened restrictions of 2016 and 2021 (along with the approval of mifepristone in general). The Northern District of Texas agreed with plaintiffs and issued an injunction effectively removing the drug from the market. The FDA appealed to the 5th Circuit, which allowed some of the lower District court’s injunction to remain. Specifically, the 5th Circuit allowed the injunction to stay in place for the restrictions on Mifepristone prior to 2016—this meant that the drug could only be prescribed within 7 weeks of pregnancy, by a physician, and with an in person initial visit. 

US Supreme Court Decision:
SCOTUS immediately accepted the case for review the lower court actions.  The Court stayed the district court’s injunction entirely pending the outcome of the case. On June 13, 2024, the Court issued a decision reversing the lower court’s on the issue of standing. The Court rejected arguments by plaintiffs on standing—in particular that they did not have a personal stake or injury in this case. Specifically, they were associations and physicians that did NOT prescribe or use the drug at issue—they were challenging the regulation of OTHERS, not themselves. The decisions was unanimous. Plaintiffs lacked standing to bring their claims. The Court has remanded the case back to the trial court for action (dismissal). Review the decision here > 

What does this mean for providers in Ohio? 
Ohio does have legal restrictions on telemedicine prescribing and use of medication induced abortion. 

As you may know, Planned Parenthood asked an Ohio court to strike down Mifepristone restrictions in Ohio law (Planned Parenthood v. Dept. of Health, Hamilton County CP. Case No. A 2101148). They have asked the court to declare unconstitutional a patchwork of statutes that prohibit advanced practice clinicians from providing medication abortions, along with R.C. 2919.123 which limits the prescription and administration of mifepristone in medication induced abortions to strictly the manner in as is described on the FDA’s final drug label instructions, which includes a ban on use 70 days past the patient’s last missed period. That court has yet to issue any decision on this matter. 

Thus, the existing restrictions on the prescription and use of Mifepristone in Ohio remain effective despite the SCOTUS decision.

Ohio Medical Board Rejects Petitions for New Medical Marijuana Conditions

 
The State Medical Board of Ohio rejected two proposed conditions for inclusion as qualifying conditions for the recommendation of medical marijuana.
 
As a reminder, the Board receives petitions for new qualifying conditions each January. If those petitions meet the legal requirement of the offer of potentially supportive scientific evidence, or for a previously rejected condition, the offer of new potentially supportive scientific evidence, the Board will review those conditions and evidence for potential inclusion of qualifying conditions. 
 
In May 2024, the State Medical Board of Ohio received expert third-party reports for the petitions to add two (2) new conditions to the Board’s list of those permissible for a medical marijuana condition. Those two (2) proposed conditions were (1) Autism Spectrum Disorder, and (2) Female Orgasmic Difficulty Disorder.
 
On June 12, 2024, the Board held its monthly meeting and, based on the recommendation of experts and its own review, rejected the inclusion of both conditions for inclusion on the list of qualifying conditions.
 
There are currently 26 conditions eligible for a medical marijuana recommendation. Review the list here >
 
 

HHS Issues New HIPAA Privacy Rule for Reproductive Health Information

 
This spring, the HHS Office of Civil Rights issued a new rule stemming from the US Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization. The Biden Administration created this rule out of concern that some reproductive health information held by HIPAA Covered Entities could be used to initiate criminal or civil investigations or proceedings specifically for reproductive health care. The rule comes as some states now have laws that criminalize or penalize abortion services in particular.
 
Compliance with this new rule will become applicable to HIPAA Covered Entities (including health care providers) on December 23, 2024.
 
The rule essentially updates HIPAA in three ways:

1.)    It prohibits the use or disclosure of public health information when it is sought to investigate or impose liability on individuals or health care providers who seek, obtain, provide, or facilitate reproductive health care that is lawful under the circumstances in which such health care is provided, or to identify persons for such activities.
a.       The “lawful under the circumstances” is intended to capture circumstances where the protected information is sought and the reproductive health care provided (abortion) is legal. It does not appear that these protections will extend to jurisdictions where the health care information at issue concerns care that is not lawful (states where abortion is restricted).
b.       Again, this applies in circumstances where the protected reproductive health care information is being requested to conduct an investigation of the care provided (or to identify individuals).

2.)    Requires a regulated health care provider to obtain a signed attestation that certain requests for protected health information potentially related to reproductive health care are not for these prohibited purposes.

3.)    Requires regulated health care providers to modify their Notice of Privacy Practices to support reproductive health care privacy.
 
View the rule and related materials here >

OSMA will continue to monitor the Feds guidance in the implementation of this rule and update our members accordingly. If you have question, please contact Sean at smccullough@osma.org.

 

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