Analysis, commentary, and the latest developments in health care law and policy
The results of the 2022 U.S. midterm elections—during which voters were focused on the economy, public safety, and health care and abortion issues—will have longstanding consequences for the development of health care policy over the next two years. With the U.S. House of Representatives and U.S. Senate controlled by different parties, it will be difficult for Congress to come to bipartisan agreement and pass significant health legislation during the 118th Congress. As a result, the Biden Administration will focus on implementing regulations for key legislative accomplishments and leveraging executive and regulatory authority to advance policy priorities, including implementing the Inflation Reduction Act, lowering health care and prescription drug costs for patients, and addressing health equity gaps across population groups. Considering the impact of the COVID-19 pandemic and expected unwinding of the public health emergency (PHE), concerns regarding health care financing and Medicare Trust Fund solvency, and the acceleration in the adoption of health information technology and digitization in recent years, implementation of these policy priorities will have a substantial impact on all stakeholders within health systems.
In 2023, we expect to see health care policy developments in the following key domains: reproductive rights and gender discrimination, health data privacy, telehealth, and price transparency.
Reproductive Rights and Gender Discrimination
Following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, federal agencies have taken a number of actions to provide resources and guidance on health data privacy in accordance with 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 health care providers reminding them of their responsibilities, irrespective of conflicting state laws or mandates, to provide stabilizing medical treatment to pregnant patients under the Emergency Medical Treatment and Active Labor Act (EMTALA). HHS also issued guidance reminding retail pharmacies of their nondiscrimination obligations under Section 1557 of the Affordable Care Act and directing pharmacies to not discriminate against customers on the basis of sex and disability (e.g., those seeking medication abortion). While the EMTALA guidance is currently being challenged in federal court, we expect the Administration to address additional issues related to reproductive health care services, including state policies affecting telehealth and travel restrictions for abortion. Without bipartisan agreement in the divided Congress, passage of wide-ranging abortion legislation is unlikely.
Over the summer, the HHS Office of Civil Rights (OCR) issued a notice of proposed rulemaking implementing Section 1557 of the Affordable Care Act and establishing antidiscrimination requirements applicable to health care entities. The proposed rule restores and strengthens certain civil right protections under federally funded health programs and HHS programs which were limited following the previous versions of the rule, specifically regarding discrimination on the basis of sex, including sexual orientation and gender identity. Notably, the proposed rule also addresses the application of federal conscience and religious freedom laws and establishes a process to review whether an entity is entitled to an exemption or modification of the 1557 regulations based on such laws. Comments on the proposed rule closed in October, and we expect related developments on regulations addressing gender discrimination in federal health programs.
Health Data Privacy
As a result of the Dobbs decision, the Biden Administration also continues to issue regulations to protect patients’ health data privacy, including reproductive health information. In August, the Federal Trade Commission also issued a notice of proposed rulemaking on the prevalence of commercial surveillance and data security practices, including in the health care sector. Most recently, the OCR issued a bulletin to outline the obligations of Health Insurance Portability and Accountability Act of 1996 (HIPAA) on regulated entities when using online tracking technologies and notably includes several examples focused on protecting reproductive health information. Building on these actions, we expect federal agencies to issue additional guidance on the HIPAA privacy rule and protecting reproductive health care information.
In addition to changes in guidance to support reproductive health care 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 proposes to make sweeping changes to regulations at 42 C.F.R. part 2 (“Part 2”) governing the confidentiality of substance use disorder records. As we previously discussed, these modifications are intended to align Part 2’s currently stringent rules more closely with health information privacy rules promulgated under HIPAA and to improve the ability of entities subject to Part 2’s restrictions to use, disclose, and redisclose substance use disorder-related information. Regulatory action on health data privacy is being taken against the backdrop of stalled Congressional negotiations on the American Data Privacy and Protection Act (H.R.8152), which proposes to establish a national data security and digital privacy framework, as well as other data privacy bills. Bipartisan lawmakers agree that additional safeguards are needed to protect consumers’ online data, which indicates that we may see legislative action in the new Congress.
Depending on whether telehealth extensions are included in the fiscal year 2023 appropriations legislation, Congress may act to bolster federal support for telehealth and extend certain Medicare telehealth flexibilities beyond the COVID-19 PHE. HHS recently extended numerous telehealth flexibilities in the 2023 Medicare Physician Fee Schedule Final Rule for 151 days after the end of the COVID-19 PHE, in alignment with the Consolidated Appropriations Act, 2022. In July 2022, the House of Representatives passed, 416-12, the Advancing Telehealth Beyond COVID-19 Act of 2021 (H.R.4040), which modifies the extension of certain Medicare telehealth flexibilities (i.e., waiving originating site restrictions; allowing audio-only coverage; and expanding the list of telehealth practitioners) through December 2024. HHS will likely provide additional resources and guidance on telehealth, specifically regarding originating site and delivery modality flexibility. During the COVID-19 pandemic, members of Congress and the Biden Administration have acknowledged the importance of telehealth for providing continued access to care, especially for certain vulnerable populations, and have expressed interest in expanding federal support for telehealth.
In 2023, Congress and the Administration will continue to advance price transparency efforts and urge hospitals to comply with the Hospital Price Transparency Final Rule, which required hospitals to disclose their standard charges and make prices publicly available for consumers. In September, the HHS Office of the Inspector General (OIG) announced that it would review the controls in place at the Centers for Medicare & Medicaid Services (CMS) and statistically sample hospitals to determine whether CMS’s controls are sufficient to ensure that hospital pricing information is readily available to patients as required by law. The findings of OIG’s review are expected to be released next year. On the Congressional side, bipartisan leaders of the House Energy and Commerce Committee continue to express concern about hospital noncompliance with the final rule. Committee leaders recently sent a letter to the Government Accountability Office requesting that it examine hospital compliance with the provisions of the Hospital Price Transparency Final Rule in addition to CMS’s efforts to monitor and enforce hospital compliance.
In regard to the Administration’s price transparency efforts, we also expect to see rulemaking from HHS, along with three other federal agencies, on advanced explanation of benefits and good faith estimate (GFE) requirements of the No Surprises Act after they had issued a request for information in September. Most recently, HHS announced that it would extend beyond January 1, 2023 its enforcement discretion, pending future rulemaking, on the requirement that health care providers make available GFEs to uninsured and self-pay individuals when there are co-providers or co-facilities under the No Surprises Act.
In collaboration with Crowell & Moring Government Affairs Group and Crowell & Moring International, Crowell Health Solutions will examine the post-election landscape in health care policy on December 13 at 1:00 PM. We invite you to attend this webinar on what to expect in health care in 2023 in Washington DC, across the U.S., and abroad and how potential policy changes may impact your organization. Register for the webinar here.
Crowell Health Solutions is a strategic consulting firm focused on helping clients to pursue and deliver innovative alternatives to the traditional approaches of providing and paying for health care, including through digital health, health equity, and value-based health care.
Jodi Daniel is a partner in Crowell & Moring’s Health Care Group and a member of the group’s Steering Committee. She is also a director at C&M International (CMI), an international policy and regulatory affairs consulting firm affiliated with Crowell & Moring. She…
Jodi Daniel is a partner in Crowell & Moring’s Health Care Group and a member of the group’s Steering Committee. She is also a director at C&M International (CMI), an international policy and regulatory affairs consulting firm affiliated with Crowell & Moring. She leads the firm’s Digital Health Practice and provides strategic, legal, and policy advice to all types of health care and technology clients navigating the dynamic regulatory environment related to technology in the health care sector to help them achieve their business goals. Jodi is a contributor to the Uniform Law Commission Telehealth Committee, which drafts and proposes uniform state laws related to telehealth services, including the definition of telehealth, formation of the doctor-patient relationship via telehealth, creation of a registry for out-of-state physicians, insurance coverage and payment parity, and administrative barriers to entity formation.
Troy Barsky is a partner in Crowell & Moring’s Washington, D.C. office, and serves as a member of the firm’s Health Care Group Steering Committee where he focuses on health care fraud and abuse, and Medicare and Medicaid law and policy. Troy counsels…
Troy Barsky is a partner in Crowell & Moring’s Washington, D.C. office, and serves as a member of the firm’s Health Care Group Steering Committee where he focuses on health care fraud and abuse, and Medicare and Medicaid law and policy. Troy counsels all types of health care entities, including hospitals, group practices, and health plans on the physician self-referral law (Stark Law) and the Anti-Kickback Statute, innovative healthcare delivery models, such as Accountable Care Organizations (ACOs), and Medicare & Medicaid payment and coverage policy. He also defends clients seeking resolution of government health care program overpayment issues or fraud and abuse matters through self-disclosures and negotiated settlements with the U.S. Department of Justice, U.S. Health & Human Services Office of the Inspector General and the Centers for Medicare & Medicaid Services (CMS).
Crowell & Moring’s C&M Health Law blog is committed to providing real-time analysis and commentary on the latest developments in health care law and policy. Our attorney authors are part of a diverse and growing practice from coast to coast. We understand that health care organizations need legal representation that cuts directly to the heart of any issue, whether in litigation, government investigations, regulatory compliance, or business collaborations and acquisitions. Our lawyers have deep experience in health care antitrust, managed care, fraud and abuse (including Stark, anti-kickback and False Claims Act matters), and privacy litigation, among other key regulatory areas. For more on Crowell & Moring’s health care practice …
Top Healthcare Policy Developments in 2023; Register for Crowell Health Solutions Webinar – C&M Health Law
Analysis, commentary, and the latest developments in health care law and policy