Health Law Advisor

On February 7, the National Institutes of Health (“NIH”) issued a Notice (NOT-OD-25-068) entitled “Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates” (the “Notice”), though which NIH announced the adoption of a uniform indirect cost rate (“IDC Rate”) of 15% applicable to all new grants, and to existing grants awarded to Institutions of Higher Education (“IHEs”) – encompassing the vast majority of postsecondary educational institutions in the United States – as of the date the Notice was issued (February 7, 2025). The Notice also indicates the policy will apply for “all current grants for go forward expenses from February 10, 2025 as well as for all new grants issued.” The Notice, as written and supported by underlying regulations, appears to apply the 15% IDC Rate to existing awards only for IHE recipients (see the Notice’s acknowledgment that “NIH may deviate from the negotiated rate both for future grant awards and, in the case of grants to institutions of higher education (“IHEs”), for existing grant awards.  See 45 CFR Appendix III to Part 75, § C.7.a; see 45 C.F.R. 75.414(c)(1).” (emphasis added)). However, there is some ambiguity in the wording and existing non-IHE awardees should be prepared for a possibly broader read by the NIH. The IDC Rate covers “facilities” and “administration” costs of the grantee institution. As a general matter, an institution’s IDC Rate is pre-negotiated and although the NIH cited 27-28% as the average negotiated IDC Rate, it has been reported that many institutions negotiate upwards of 50-60%, with some even as high as 75%.

On April 1, 2024, the U.S. Department of Health and Human Services (“HHS”) released new guidance which requires hospitals to obtain informed consent from patients before practitioners, or medical or other students, perform important surgical tasks or sensitive or invasive procedures or examinations (“Guidance”). The Guidance aims to address increasing concerns over patient privacy, in particular the performance of sensitive examinations and invasive procedures on anesthetized patients.

The Guidance both revises the Hospital Interpretive Guidelines regarding ...

On Monday, March 11, 2024, the Office of the National Coordinator for Health Information Technology’s (ONC) Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule went into effect. Among several elements of HTI-1, ONC promulgated “information blocking enhancements” which include new and updated definitions, as well as new and updated information blocking exceptions. Other sections of HTI-1 introduce algorithm transparency and replace “clinical decision support” ...

On November 7, 2023, the citizens of the state of Ohio voted to codify reproductive rights, including the right to abortion, in the state constitution.

In 2019, Ohio banned nearly all abortions once fetal cardiac activity was detected (typically around six weeks’ gestation) through its “Heartbeat Law.” Challenges to Ohio’s Heartbeat Law  under Roe v. Wade and Planned Parenthood v. Casey prevented it from taking effect until the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization repealed those cases. After Dobbs, Ohio’s “Heartbeat ...

On December 1, 2022, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) published a bulletin warning that commonly used website technologies, including cookies, pixels, and session replay, may result in the impermissible disclosure of Protected Health Information (“PHI”) to third parties in violation of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). The bulletin advises that “[r]egulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of Protected Health Information (“PHI”) to tracking technology vendors or any other violations of the HIPAA Rules.” The bulletin is issued amidst a wider national and international privacy landscape that is increasingly focused on regulating the collection and use of personal information through web-based technologies and software that may not be readily apparent to the user.

Announced in the Consolidated Appropriations Act of 2021, Rural Emergency Hospitals (REHs) will be a new type of Medicare provider starting January 1, 2023.  REHs are meant to help address the stressed health care system of rural providers by providing an option to closure for distressed critical access hospitals (CAHs) and small rural hospitals.

Existing CAHs and rural hospitals with fewer than 50 beds will be eligible to convert to an REH.  CMS is streamlining this process so that this conversion to be an REH can be accomplished through a change of information on an existing Medicare 855A enrollment rather than through a new provider application, which carries potentially significant delays and potential gaps in payment.  REHs are designed to provide primarily emergency department, observation, and outpatient services.  Because REHs will not provide inpatient care, an area that often creates a significant financial and operational burden on CAHs and small rural hospitals, REHs will allow locally-delivered healthcare to continue to be furnished by existing providers.