The long-term consequences of Dobbs The decision is unknown, but its impact on stakeholders in the healthcare industry will continue for years to come.
The decision of the US Supreme Court of June 2022 in Dobbs v. Jackson Women’s Health Organizationwho fell over Roe v. calf and finding that the US Constitution does not grant abortion rights has created significant confusion and uncertainty for companies investing in and investing in the healthcare industry.
Affected organizations include life science companies and their strategic partners and investors focused on products such as pharmaceuticals, medical devices and diagnostic tests; Healthcare providers such as hospitals, abortion clinics, first responders, fertility clinics, and physician office groups; and digital health companies, telemedicine and teleconsultation providers, and other emerging industry platforms. The aftershocks are being felt across the industry.
The legal and enforcement landscape is complex and ever-changing. It will continue to evolve rapidly due to legislative activity, court challenges and the outcome of the upcoming midterm elections. It is therefore important to understand the key federal guidance that has been issued since Dobbs decision and to appreciate the ongoing challenges in reconciling federal and state regulations.
Dobbs raises many questions
Following Dobbs, there are likely to be conflicts between the agencies that enforce federal laws and some agencies that enforce current and future state laws affecting reproductive rights. The conflict will raise many questions, including the following:
- What is the definition of personality, property rights and human reproductive tissue?
- Does the definition of pregnancy include oocytes fertilized by IVF or fertilized embryos in cryostasis?
- How does the law define termination? Does abortion include drugs or other products used to terminate a pregnancy or treat conditions related to miscarriage?
- When does a stabilizing treatment become an emergent treatment?
How these questions are answered will have significant ramifications for the health and wellness industry. Healthcare providers could lose their licenses or professional permits, including government certifications. You could also be subject to criminal and civil fines and penalties. Pharmaceutical companies could lose their state distribution and wholesale licenses. Digital healthcare companies may need to share private patient data stored in their apps, which could have a significant impact on their businesses. And some advocacy groups could be excluded from Medicare, which would be financially devastating for many providers who rely on government reimbursements.
In the wake of Dobbsthe federal government has attempted to reassert its authority to provide safeguards and ensure protection, including in relation to data protection and the right to health services.
The US Department of Health and Human Services (HHS) recognizes the importance of personal health information and clearly anticipates ongoing conflicts between prosecutors seeking to enforce restrictive state abortion laws and federal agencies. Since the Dobbs Decision, HHS issued guidance and reminders to its stakeholders (providers, patients, and pharmacies) about their obligations under federal law. Following Dobbsthe first HHS guidance focused on when a company must disclose protected health information under the Health Insurance Portability and Accountability Act (HIPAA).
HIPAA has privacy and security rules designed to protect health information that is transmitted, maintained, stored, or disclosed by covered organizations. Under HIPAA, these Covered Entities include health insurers, healthcare providers and healthcare clearinghouses, and business partners—companies and individuals that perform services on behalf of Covered Entities. There are, of course, exceptions to the HIPAA privacy rules. Most importantly, a covered company or business partner may not use or disclose protected health information without a patient’s signed authorization to do so. Without patient approval, disclosure requirements fall under one of HIPAA’s permitted exceptions.
The exceptions to HIPAA privacy rules that HHS emphasizes in its guidance are disclosures (i) required by law, (ii) for law enforcement purposes, and (iii) to prevent a serious threat to health or safety. HHS reminded its stakeholders that these are permitted disclosures, not required disclosures. In other words, prospects can respond to a subpoena under HIPPA in certain circumstances determined by HHS; however provider do not have to respond to this subpoena under HIPPA.
HIPAA does not generally apply to data stored in third-party digital health apps. However following Dobbs, there was widespread confusion about the protections HIPAA provides for health data stored in third-party apps like period trackers, leading to significant user misconceptions about digital health and wellness apps and “data dumping.” To address this confusion, HHS has released more general guidance for patients and the public to remind individuals of the steps they can take to protect the personal health information they may have shared with digital health apps.
Obligations to provide healthcare
Another important release from HHS follows Dobbs came from the agency’s Centers for Medicare & Medicaid Services, which issued guidance to help healthcare providers reaffirm their obligations under the Emergency Medical Treatment and Labor Act (EMTALA). Under EMTALA, any person presenting for treatment in a hospital emergency room must be stabilized and treated or transferred to another facility for treatment, regardless of whether they are able to pay for their treatment. Therefore, patients pregnant on EMTALA or with complications related to pregnancy or miscarriage presenting for emergency department care should be stabilized and/or transferred as determined by the personal medical judgment of the treating physician.
Many emergency room and health care providers are concerned that EMTALA will require them to provide stabilizing care that includes abortions in states where the provision of abortion services is illegal. Federal laws including EMTALA, Trump state laws including state abortion laws. Although EMTALA anticipates state laws, many providers who must make life-saving clinical decisions in emergency situations remain concerned about the risk of violating state laws, which carry criminal penalties.
HHS’s Office of Civil Rights (OCR), which enforces HIPAA, also issued guidance to retail pharmacies in July 2022, reminding them that refusing to distribute a pharmaceutical product to a patient who is struggling with complications of pregnancy or miscarriage , would be considered discrimination under HHS civil rights laws. In addition, OCR sent a letter to health insurers reminding them that under the Affordable Care Act (ACA) they are required to insure contraception, which is one of the many preventative services covered under the ACA’s mandate.
We’re just beginning to understand Dobbs‘ Implications
The Biden administration shortly thereafter issued an executive order (“Protecting Access to Reproductive Health Services”) Dobbs decision has been published. While the Executive Order did not provide detailed guidance and direction of subsequent HHS publications, it did specifically list goals to ensure access to abortion, protect privacy, promote the safety and security of patients and providers, and support the efforts of the Coordinate federal protection of reproductive rights. The executive order also underscores to stakeholders in the healthcare industry – whether insurers, providers, manufacturers or patients – that HHS is watching closely Dobbs and their far-reaching implications for the industry.