Top Health Policy Developments in 2023; Register for the Crowell Health Solutions webinar

The results of the 2022 US midterm elections – in which voters focused on the economy, public safety, and health and abortion issues – will have long-term ramifications for health policy developments over the next two years. Because the U.S. House of Representatives and Senate are controlled by different parties, it will be difficult for Congress to hold a vote during the 118thth Congress. As a result, the Biden administration will focus on enforcing regulations on key legislative gains and using executive and regulatory agencies to advance policy priorities, including implementing the Anti-Inflation Act, lowering healthcare and prescription drug costs for patients and addressing gaps in health equity among populations. Recognizing the impact of the COVID-19 pandemic and the expected resolution of the Public Health Emergency (PHE), concerns about healthcare funding and the solvency of the Medicare Trust Fund, and accelerating the adoption of healthcare information technology and digitization in recent years, implementation of these policy priorities will have a significant impact on all stakeholders in health systems.

In 2023, we expect health policy developments in the following key areas: reproductive rights and gender discrimination, health data protection, telemedicine and price transparency.

Reproductive rights and gender discrimination

According to the decision of the Supreme Court in Dobbs v. Jackson Women’s Health Organization, Federal agencies have taken a number of actions to provide resources and guidance on protecting health information under President Joe Biden’s executive order to support access to reproductive health care. In July, the Department of Health and Human Services (HHS) issued guidance and sent a letter to healthcare providers reminding them of their responsibility, regardless of conflicting state laws or mandates, to provide stabilizing support to pregnant patients as part of emergency medical care to provide medical treatment and active labor law (EMTALA). HHS has also issued guidance reminding retail pharmacies of their nondiscrimination obligations under Section 1557 of the Affordable Care Act, directing pharmacies not to discriminate against customers based on gender and disability (e.g., those seeking medical abortion). While the EMTALA guidelines are currently being challenged in federal court, we expect the government to address additional issues related to reproductive health services, including state policies affecting telemedicine and travel restrictions for abortions. Without a bipartisan agreement in the divided Congress, passage of far-reaching abortion legislation is unlikely.

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Over the summer, the HHS Office of Civil Rights (OCR) issued a notice of proposed regulations to implement Section 1557 of the Affordable Care Act and establish antidiscrimination requirements for healthcare facilities. The proposed rule restores and strengthens certain civil rights protections under federally funded health care programs and HHS programs that were restricted under previous versions of the rule, particularly with respect to sex discrimination, including sexual orientation and gender identity. Specifically, the proposed rule also addresses the application of the federal statutes on freedom of conscience and religion and establishes a process for reviewing whether an entity is entitled to an exception or amendment to the 1557 regulations based on those statutes. Comments on the proposed rule were closed in October and we await corresponding developments in regulations to combat gender discrimination in federal health programs.

Health Data Privacy

As a result of Dobbs decision, the Biden administration continues to issue regulations to protect patient health information, including reproductive health information. In August, the Federal Trade Commission also issued a notice of proposed regulations on the proliferation of commercial surveillance and data security practices, including in the healthcare sector. Recently, the OCR issued a bulletin to outline the obligations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for regulated businesses when using online tracking technologies, and specifically includes several examples related to protection of reproductive health information. Building on these actions, we expect federal agencies to issue additional guidance on the HIPAA privacy rule and protecting reproductive health information.

In addition to changes in guidance to support reproductive health services, HHS has also focused on improving access to health data, supporting care coordination, and improving interoperability by issuing a notice of proposed rulemaking that includes sweeping changes to the regulations in the 42nd CFR Part 2 Proposes (“Part 2”), which regulates the confidentiality of substance use disorder records. As we previously discussed, these changes are intended to align the currently stringent Part 2 rules more closely with the health information privacy rules promulgated under HIPAA and improve the ability of organizations subject to Part 2 restrictions to use substance-related disorders, disclose and re-disclose information. Regulatory action to protect health information comes amid stalled Congressional negotiations on the US Data Protection Act (HR8152), which proposes creating a national framework for data security and digital privacy, as well as other privacy laws. Bipartisan lawmakers agree that additional safeguards are needed to protect consumers’ online data, suggesting we may see legislative action in the new Congress.

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telemedicine

Pending telemedicine extensions being included in the fiscal year 2023 appropriations legislation, Congress may act to strengthen federal support for telemedicine and extend certain Medicare telehealth flexibilities beyond the COVID-19 PHE. HHS recently extended numerous telehealth flexibilities in the final rule of the 2023 Medicare physician fee schedule for 151 days after the end of the COVID-19 PHE in accordance with the Consolidated Appropriations Act of 2022. In July 2022, the House of Representatives passed 416-12, the Advancing Telehealth Beyond COVID-19 Act of 2021 (HR4040), which provides for the extension of certain Medicare telehealth flexibilities (i.e., waiving origin location restrictions, allowing for audio-only coverage, and expanding the List of Telemedicine Providers) modified by December 2024 HHS is likely to provide additional resources and guidance on telemedicine, particularly regarding flexibility of origin and delivery modalities. During the COVID-19 pandemic, members of Congress and the Biden administration have recognized the importance of telemedicine in providing continued access to care, particularly for certain vulnerable populations, and have expressed an interest in expanding federal support for telemedicine.

price transparency

In 2023, Congress and the federal government will continue their price transparency efforts, requiring hospitals to comply with the Hospital Price Transparency Final Rule, which requires hospitals to disclose their standard fees and make prices publicly available to consumers. In September, the HHS Office of the Inspector General (OIG) announced that it would review controls in place at the Centers for Medicare & Medicaid Services (CMS) and statistically examine hospitals to determine whether CMS controls are sufficient to ensure that the hospital prices receive information is easily accessible to patients in accordance with the law. The results of the OIG review are expected to be released next year. On the side of Congress, bipartisan leaders of the House Energy and Commerce Committee continue to voice concerns about hospital failures to comply with the final rule. The committee chairs recently sent a letter to the Government Accountability Office asking that it audit hospitals’ compliance with the provisions of the Hospital Price Transparency Final Rule in addition to CMS’ efforts to monitor and enforce compliance with hospital regulations .

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In relation to the government’s pricing transparency efforts, we also anticipate that HHS, along with three other federal agencies, will enact regulations to meet the No Surprises Act’s requirements for an enhanced declaration of benefits and good faith estimate (GFE) after they receive a HHS filed an application for info in Sept. Most recently, HHS announced it would extend its enforcement discretion until January 1, 2023 in anticipation of future regulations to include the requirement that healthcare providers provide GFEs for uninsured and self-paying individuals if it Co-providers or co-facilitators are subject to the No Surprises Act.

Next Steps

Working with the Crowell & Moring Government Affairs Group and Crowell & Moring International, Crowell Health Solutions will examine post-election health policy at 1:00 p.m. on December 13. We invite you to join this webinar on what to expect in healthcare in 2023 in Washington DC, the US and abroad and how potential policy changes may impact your business. Register for the webinar here.

Crowell Health Solutions is a strategic consulting firm focused on helping clients pursue and deliver innovative alternatives to traditional approaches to delivering and paying for healthcare, including through digital health, healthcare equity and value-based healthcare.

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