Final Rule Research Articles

Enrollment of race/ethnicity in ophthalmic clinical trials before and after the Final Rule.

The Final Rule (42 CFR Part 11) conditionally requires race/ethnicity reporting among clinical trials registered on Clinicaltrials.gov, but the effect of this policy on the demographic makeup of ophthalmic clinical trials is unknown. We analyzed the effect of the Final Rule on the enrollment of racial and ethnic groups in ophthalmic clinical trials. In this retrospective database study, ClinicalTrials.gov was queried for "eye," "eye diseases," and "ocular." US-based trials with a completed status, results available, and enrollment greater than or equal to 50 participants were included (n=872). Trials with a study start date on or after April 18, 2017 (the compliance date of the Final Rule) were categorized as "post-requirement" (n=200) trials. Trials with a study start date prior to this date were categorized as "pre-requirement" (n=672) trials. The primary and secondary outcome was the enrollment of each race/ethnicity category and the disclosure rate of any race/ethnicity information, respectively. The enrollment and disclosure rate before and after the implementation of the Final Rule was compared with the Mann-Whitney U-test and Pearson's chi-squared test, respectively. White participant enrollment significantly increased while the enrollment of participants with an unknown race significantly decreased among post-requirement trials compared to pre-requirement trials (p<.005). The enrollment of American Indian/Alaskan Native, Native Hawaiian/Other Pacific Islander, and White enrollment was significantly higher among trials funded by the National Institutes of Health (NIH) compared to non-NIH funded trials among pre-requirement but not post-requirement trials (p<.005). The disclosure rate of any race/ethnicity information increased significantly (p<.001) among post-requirement trials (91.00%) compared to pre-requirement trials (38.39%). The enrollment rate by race/ethnicity remained unchanged for minority racial and ethnic groups, despite the increased race/ethnicity disclosure rate in ophthalmic clinical trials after the implementation of the Final Rule. Additional mechanisms may be needed to bridge persistent disparities in racial/ethnic minority enrollment into clinical trials.

Sounding Off: Pharmacist Insights on Over-the-Counter Hearing Aids: A Qualitative Focus Group Study.

Sounding Off: Pharmacist Insights on Over-the-Counter Hearing Aids: A Qualitative Focus Group Study.

Advocates fear implications of retreat on parity enforcement

The imperiled future of Medicaid has largely occupied the attention of those tracking federal policy moves affecting substance use treatment in recent weeks, but advocates also are keeping a close eye on developments with the federal parity law. The Trump administration's indication last month that it will not enforce the provisions of the final rule on parity that took effect last fall has intensified concern that progress in holding insurers accountable for providing equitable substance use coverage will be lost.

Medicare Home Health Social Workers’ Views on New OASIS Questions on Housing, Food, Utilities, and Transportation

In its 2025 final payment rule for Medicare Home Health published November 7, 2024, the Centers for Medicare and Medicaid Services added 5 questions to the outcome and Assessment Information Set (OASIS) needing to be addressed: 4 new (i.e., 1 on living situation; 2 on food insecurity; 1 on utilities) and 1 that revised transportation. The rule states that the changes are responsive to issues in the social determinants of health category and take effect with the calendar year 2027 Home Health Quality Reporting Program. A literature review indicates no studies on the potential impact of these OASIS revisions on Medicare home health social work services, the service for social needs. This article summarizes an initial, exploratory study to address the literature gap, based on interviews of 31 Medicare home health social workers between January 6, 2025, and February 9, 2025, in the New York City metropolitan area. Three themes emerged, including: social workers believe the new requirements (1) are overdue, needed, and provide the potential to increase services to deal with many unmet social needs; (2) Medicare continues to neglect the expansion of social work coverage and payment to home health agencies for supplemental social needs necessary to make the new requirements effective for Medicare home health patients; and (3) Medicare still does not mandate that any Social Determinants of Health need detected through the new OASIS requirements must receive follow-up care with appropriate, covered interventions and the OASIS questions do not affect scoring for episode payment.

Abstract P4-02-06: Assessing the True Cost of Breast Cancer Screening: Chargemaster, Payer, and Cash Price Discrepancies for Mammography

Abstract Introduction: Patients in the United States (US) often lack information about the price of breast cancer screening services across hospitals and payers. Recent legislation in the US, including the 2021 Hospital Price Transparency Final Rule, requires hospitals to publish standard chargemaster rates, payer-specific negotiated prices, and discounted cash prices for all services, creating a unique opportunity to understand variation in hospital pricing. While uninsured or underinsured patients may be exposed to high chargemaster rates for screening services, those who are able to pay upfront in cash or have negotiated rates through insurance face significantly discounted prices. More research is needed to better understand the relationship between the distinct screening prices facing patients in the United States. Methods: We extracted standard chargemaster prices, payer-specific negotiated prices, and self-pay cash prices for screening mammography (CPT code 77067) from machine-readable files published by ten top US hospitals. For each hospital, we compared the standard chargemaster rate for screening mammography with the average payer negotiated price and determined the chargemaster-payer price ratio. Additionally, we compared the standard chargemaster rates and discounted cash prices for screening mammography, and determined the chargemaster-cash price ratio for each hospital. Results: Across ten top US hospitals, the average chargemaster rate for screening mammography was $855. The average cash price for the same service was $305, with an average chargemaster-cash price ratio of 3.7. The average payer-negotiated price for screening mammography was $411, and chargemaster rates were greater than payer-negotiated prices by an average factor of 2.2. The average cash price for breast cancer screening was 74.2% of the average payer negotiated rate for the same service. We observed wide variation across institutions for chargemaster rates, payer-negotiated rates, and discounted cash prices for screening mammography, with interquartile ranges of $198, $292, and $203, respectively. Conclusion: Across ten top US hospitals, the chargemaster price for screening mammography was greater than the average payer negotiated rates and discounted cash price for the same service by a factor of 2.2 and 3.7, respectively. This price discrepancy has important consequences for individuals seeking essential breast cancer screening services, with uninsured patients facing prohibitive costs. As curable breast cancers go undetected, the burden on the healthcare system escalates. Policies should aim to improve price transparency, equity, and access to lifesaving breast cancer screening for the most vulnerable populations in the United States. Citation Format: Mason Alford-Holloway, Austin Triana, Katherine Baker, Samyukta Mullangi. Assessing the True Cost of Breast Cancer Screening: Chargemaster, Payer, and Cash Price Discrepancies for Mammography [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2024; 2024 Dec 10-13; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2025;31(12 Suppl):Abstract nr P4-02-06.

RadGPT: A system based on a large language model that generates sets of patient-centered materials to explain radiology report information.

RadGPT: A system based on a large language model that generates sets of patient-centered materials to explain radiology report information.

An analysis of primary care safety-nets' preventive service provision with a new composite reporting measure.

The 2024 Final Rule for physician fee schedule under the Medicare Prospective Centers for Medicare & Medicaid Services (CMS) has sunset and combined seven screening and quality measures for traditional Medicare Merit-Based Incentive Payment System (MIPS) reporting with a single composite clinical quality process measure, Preventive Care and Wellness (PCW). While composites offer benefits including statistical efficiency and increased stability over time, the contextless nature of composite scores may result in disadvantaging low-resource primary care health centers ("health centers") serving medically underserved communities that face healthcare access and outcome challenges. Evaluate the CMS composite score metric in health centers to identify characteristics that are associated with higher versus lower composite scores. We conducted a 4-year (2019-2022) retrospective data analysis with more than 1.5 million patients from 191 primary care health centers within the OCHIN national network of community health organizations (CHOs). The primary outcome is a modified version of the PCW. Generalized linear mixed models assessed clinic factors associated with score variation, accounting for repeated measures. Our analysis demonstrated that prepandemic scores started to recover by the end of 2022 (0.6644 vs. 0.6153) and that five factors (pediatric or 65+ patients, Hispanic adults, uninsured patients, and clinic encounter volumes in Q2 and Q4) significantly affected clinic score variation over time. Our analyses show that preventive service delivery in health centers has nearly recovered from pandemic declines. Differences in subpopulations highlight the importance of context in interpreting health centers' score variation.

Decreasing Medicare Reimbursement for Facility-Performed Neurotology Procedures From 2000 to 2024.

To understand trends in Medicare reimbursement for neurotology procedures from 2000 through 2024. The Physician Fee Schedule (PFS) Look-Up Tool from the Center for Medicare and Medicaid Services was used to assess reimbursement data for relevant otologic/neurotologic Current Procedural Terminology (CPT) codes from 2000 to 2024. All monetary data were adjusted to 2024 U.S. dollars using the U.S. Bureau of Labor Statistics Consumer Price Index. Percent changes in reimbursement were calculated. The average nominal value of reimbursement for all procedures increased by 11.20% from 2000 to 2024. However, after adjusting for inflation, the average change in Medicare reimbursement was -33.52%. The greatest decrease was in CPT code 69714, which saw a 2024 U.S. dollar -66.43% change. The greatest increase was in CPT code 61798, which saw a 43.43% change. An increase in reimbursement for all CPT codes occurred only in 2024. This increase was associated with the calendar year 2024 PFS final rule, which came into effect on March 9 and increased the PFS conversion factor from $32.7442 to $33.2875. From 2000 to 2024, the PFS conversion factor decreased from $36.6137 to $33.2875. From 2000 to 2023, Medicare reimbursements for otologic and neurotologic procedures decreased after adjusting for inflation. The only year with an increase in reimbursement was 2024, which saw an increase to the PFS conversion factor. These trends highlight the need for greater awareness of, and agreement on, neurotology reimbursement models among surgeons, policy makers, and facility administrators.

Hypothetical demand for menthol and non-menthol cigarettes and substitution among people who smoke menthol cigarettes: A within subjects between group randomized controlled trial using the experimental tobacco marketplace.

Hypothetical demand for menthol and non-menthol cigarettes and substitution among people who smoke menthol cigarettes: A within subjects between group randomized controlled trial using the experimental tobacco marketplace.

Parity enforcement hangs in balance as advocacy community mobilizes

The Trump administration's decision not to defend the provisions of the mental health parity final rule that took effect last year has left the advocacy community scrambling to identify options for maintaining parity's momentum. While it doesn't appear that all parity enforcement activity at the federal level has ceased, there remains great concern that the current regulatory environment in Washington gives insurers free rein to block access to necessary behavioral health services.

Spine Disease Clinical Trial Representation: An Analysis of Racial, Ethnic, and Gender Diversity.

Spine diseases significantly burden individuals' health and quality of life, affecting millions worldwide. Ensuring diverse representation in spine disease-related clinical trials, particularly concerning race, ethnicity, and gender, is essential for developing effective and safe therapies for all populations. The objective of this study was to analyze whether spine disease clinical trials have adequate representation. Detailed trial records from all US clinical trials (up to January 1, 2024) registered in ClinicalTrials.gov relating to spine disease that were completed, had results, and included participants aged older than 18 years were analyzed. Data for race, ethnicity, and gender were collected and compared with state Census demographic estimates. Trends in demographic reporting and representation of trials over time, how trial factors are correlated with these trends, and the type of trial interventions were analyzed. One hundred and ninty-three clinical trials met our inclusion criteria. From this cohort, we found that only 48.19% of trials reported race and 30.05% reported ethnicity. Most participants were White (median: 93.43%), which exceeded the state Census estimate of White representation (median: 76.58%, Asymp. Sig. P < .001). Asian, Native Hawaiian, Pacific Islander, Black, and Hispanic participants were significantly under-represented (Asymp. Sig. P < .001). For gender, men were significantly under-represented between 2008 and 2016 (Asymp. Sig. P = .027) and over-represented between 2018 and 2022 (P = .036). These results indicate that racial and ethnic minorities in spine disease-related clinical trials remain under-represented relative to the US population even after the Revitalization Act of 1993, the Food and Drug Administration Amendments Act of 2007, Section 801, and the Final Rule policy. Furthermore, gender representation fluctuated after the enactment of the policies. For this reason, clinical trials should be more aware of having adequate representation during enrollment and more transparent in reporting race, ethnicity, and gender.

Implementing Executive Orders in the Administrative State

ABSTRACTScholarship once counted the raw number of executive orders (EOs) issued as a kind of proxy for presidential power; now it grapples with whether such directives are actually implemented, a challenging puzzle since agency action is difficult for scholars to systematically observe. This article addresses that difficulty by examining bureaucratic promulgation of a final rule responding to a given EO. To factors previously hypothesized to matter for the likelihood of implementation it adds new ones, notably (1) centralization, or the extent to which an agency itself was involved in the formulation of an EO directing it to act, and (2) an agency's structural insulation from presidential control. In a set of 103 executive orders issued between 1988 and 2004, we find that centralization has little independent effect but has important interaction effects with agency insulation. More insulated agencies are less responsive than their more permeable peers to EOs created via centralized processes that exclude their input. Other factors predicting the likelihood of responsiveness are the specificity of the presidential directive and whether the agency has the substantive capacity to comply—as well as the bureaucratic influence not to.

Assessing health care disparities in US organ procurement organizations

There is extensive system-wide evidence of disparities in access to organ transplantation in the US based on race, ethnicity, and socioeconomic status. However, little information is available regarding care disparities among US organ procurement organizations (OPOs). Commissioned by the US Centers for Medicare and Medicaid Services (CMS), we studied racial/ethnic disparities in organ donation and transplantation across and within OPOs. Based on the 2020 CMS final rule, we calculated OPO donation and organ transplantation rates with 95% confidence intervals for racial (Black, White, and Asian American and Pacific Islander, AAPI) and ethnic (Hispanic and non-Hispanic) groups. OPOs were ranked with national rates as references and classified according to the CMS 3-tier system. Of the 58 OPOs, 8 and 4 had donation rates lower for Black and AAPI donors than for White donors; 21 and 18 had organ transplantation rates lower for Black and AAPI donors than for White donors; 1 and 1 had a donation rate or organ transplantation rate lower for Hispanic donors than for non-Hispanic donors. Significant racial/ethnic disparities in organ donation and transplantation exist among many OPOs, whereas the overall OPO performance is dominated by White and non-Hispanic donors. These disparities may be influenced by variations and structural barriers in resource access, donor identification, transplantation referral, and waitlisting processes–some of which lie partially outside the direct control of OPOs and disproportionately affect disadvantaged populations. Results support equitable organ donation and allocation through enhanced awareness of health care disparities, increased accountability of OPOs, and informed policies and interventions.

Disparities in physician compensation for breast and prostate cancer operations.

The objective of this study was to determine whether the Center for Medicare and Medicaid services (CMS) pays more relative value units (RVUs) for prostatectomies than mastectomies across different treatment modalities. The RVU model is public information, subject to review every 5 years at minimum and has implications directly or indirectly to every medical center in the United States. These findings shed light on how the CMS values the two most prominent cancers among men and women: breast cancer and prostate cancer. An economic evaluation was conducted to appraise physician compensation for treating breast cancer vs prostate cancer. Work RVUs, malpractice RVUs, and practice expense RVUs were collected from the CMS' 2023 Physician Fee Scheduler. The total operative times, including time spent in pre-op consultations and follow ups, used by the RVU update committee to create these values were collected from the CMS' 2023 Final Rule Physician Work Times. Surgical oncologists treating breast cancer were paid an average of 15.45 RVUs per mastectomy and 2.74 per hour. The average work RVUs paid for a prostatectomy was 24.64and 3.06 per hour. The average work RVUs paid for an axillary lymph node removal was 12.29 and 2.94 per hour. The average work RVUs paid for a pelvic lymphadenectomy was 15.87 and 3.04 per hour. The data assimilated in this study acts to illustrate the discrepancy between work RVUs for breast cancer and prostate cancer operations.

Navigating the impact of the 21st-Century Cures Act Final Rule: A national cross-sectional survey of US genetic counselors.

The 21st Century Cures Act Final Rule (Final Rule) increases patient access to their health records but raises concerns about distress and misunderstanding of automatically released results and documentation. Little is known about genetic counselors' (GCs') experiences with the Final Rule. In Fall 2023, we conducted a cross-sectional survey of US GCs about the Final Rule's perceived impact on practice and assessed if being the ordering versus non-ordering provider for genetic testing affected perceptions of Final Rule-related changes. GCs (n = 102) reported demographic and workplace characteristics, institutional policy changes, workflow changes, and perceived patient harms and benefits due to the Final Rule. To compare ordering and non-ordering providers, we conducted Fisher's exact tests for categorical variables and trend tests for ordinal variables. Open-response questions elicited examples of positive and negative patient impacts, the effects of patient characteristics, and practice changes in response to the Final Rule. Twenty-seven GCs were ordering providers and 66 were non-ordering providers. Relative to ordering providers, non-ordering providers expressed stronger agreement with statements indicating concern about the emotional impact on patients reviewing results or notes without support (p = 0.002, 33% vs. 51% strongly agree), patients misunderstanding or misinterpreting results (p = 0.025, 44% vs. 70% strongly agree), and patients contacting the inappropriate party to discuss results (p = 0.023, 19% vs. 48% strongly agree). Agreement with the statement "patients have more knowledge/context/questions at our disclosure session due to previous results review" also differed by ordering provider status (p = 0.007). In open responses, GCs expressed concerns about patients' strong emotional reactions, patients misinterpreting results, workflow disruptions, and widening health disparities. Benefits included patients' ability to be reassured, informed, or empowered earlier; ease of sharing health information; more efficient workflow due to the automatic release of results. These results emphasize the importance of clear communication within health systems and between patients and providers.

Dialing In or Dialing Out? The Relationship Between State Telemedicine Law and Access to Buprenorphine

This Article begins by reporting the results of a comprehensive 50-state survey assessing state laws and other state sources governing the telemedicine induction (“tele-induction”) and subsequent telemedicine prescription (“tele-prescription”) of buprenorphine for the treatment of opioid use disorder (“OUD”) following the expiration of the COVID-19 public health emergency (“PHE”). Original, concrete findings include: (1) the glaring patchwork of state law governing the tele-induction and subsequent tele-prescription of buprenorphine for the treatment of OUD in the United States; (2) the variety of primary authorities and secondary sources that house relevant permissions, prohibitions, and affiliated requirements; (3) the number of primary authorities and secondary authorities that were enacted or issued during or after the COVID-19 PHE, suggesting specific state intent to copy—or to counter—pandemic-era federal flexibilities; (4) the number of states that have implied, rather than express, permissions for the tele-induction and/or tele-prescription of buprenorphine; (5) the difficulty I, a veteran multi-state researcher, experienced in finding relevant sources; (6) the constant change in some sources, especially during and since the expiration of the PHE; (7) state indication of future change pending the direction of a final federal rule, which has since been issued; (8) the general lack of clarity in state law, which impedes both provider and patient knowledge of local rules and patient access and continuity of care; (9) the fact that some virtual providers of buprenorphine appear to be operating in violation of state law; (10) the inconsistent association between and among state political mapping, state regulation in other areas of health law, and buprenorphine regulation; and (11) the fact that up to eleven state laws are more restrictive, in whole or in part, than the federal government’s current telemedicine flexibilities, which means that not all prescribers and patients in these states will benefit from federal flexibilities. This Article continues by arguing for additional federal and state reform in the area of buprenorphine tele-induction and tele-prescription. On January 17, 2025, the Drug Enforcement Administration (“DEA”) and the Substance Abuse and Mental Health Services Administration (“SAMHSA”) released a final rule that will, unless changed by the new administration, limit buprenorphine tele-induction and subsequent tele-prescription to a six-month period. Then, an in-person medical evaluation (or satisfaction of another exception to the in-person evaluation requirement) must take place before additional prescribing occurs. This Article carefully disputes the safety, efficacy, and diversion concerns relied upon by the DEA and SAMHSA in the final rule, as well as similar concerns relied on by state lawmakers in restrictive state legislation. A conclusion contends that federal and state laws should permit the tele-induction and subsequent tele-prescription of buprenorphine for the treatment of OUD without limitation, consistent with federal flexibilities that applied during the COVID-19 PHE and that continue to apply through December 31, 2025.

Compliance and factors affecting reporting of spinal stenosis and spinal-fusion-related clinical trials to ClinicalTrials.gov.

Compliance and factors affecting reporting of spinal stenosis and spinal-fusion-related clinical trials to ClinicalTrials.gov.

Hospital Price Transparency in Action: An Analysis of Radiology Procedure Price Variation in Children's Hospitals Between 2023 and 2024.

Hospital Price Transparency in Action: An Analysis of Radiology Procedure Price Variation in Children's Hospitals Between 2023 and 2024.

The National Bioengineered Foods Disclosure Standard &amp; Absence Claims: The Cost of the Butterfly

The National Bioengineered Foods Disclosure Standard (“NBFDS”) is a step in the right direction in providing a uniform labeling standard for genetically engineered organisms (“GEOs”) that meet the statutory definition of “bioengineered.” Importantly, the law provides a consensus that GEOs are safe and that labeling standards should be uniform across the United States. However, the law largely fails to settle the broader debate and the issues associated with GEO labeling. Namely, the NBFDS’s use of the term “bioengineered” causes additional confusion, and terms like “genetic modification” and “genetic engineering” remain ambiguous. Furthermore, the Final Rule promulgated by the U.S. Department of Agriculture’s (“USDA’s”) Agricultural Marketing Service also creates critical grey areas that work against Congress’s intent in passing the NBFDS. This Comment uses research from the areas of biotechnology, psychology, law, economics, and public policy to examine a key failure of the NBFDS and overall labeling framework. Under the current regulations, companies are allowed to use deceptive absence claims, like “Non-GMO,” which causes significant harm to consumers and competitors. Companies using absence claims could also be harmed in the form of costly litigation and legal penalties if they are sued for false advertising. This Comment concludes that additional regulations are needed to better fulfill the NBFDS’s purpose and to mitigate the deception caused by absence claims. Specifically, this Comment recommends that the USDA’s labeling authority be expanded to include absence claims, the “Non-GMO” label be prohibited entirely, and the use of other absence claims be better regulated. This Comment explains how courts, agencies, or Congress could improve the NBFDS to include these recommendations.

Addressing language barriers in access to genetic testing under the United States 21st Century Cures Act.

The Final Rule of the 21st Century Cures Act ("Cures") in the United States, which healthcare professionals (HCPs) were required to comply with starting in 2021, transformed clinical care by providing patients with immediate electronic access to their medical records. This often included the option to view their genetic testing results before discussing them with HCPs. "Cures" overarching goal was to enhance healthcare access and empower patients. However, a crucial limitation within the implementation of this legislation is the absence of language concordance in the dissemination of test results. While immediate access to test results may be a significant advancement, these results are predominantly offered in English, creating a formidable barrier for patients with limited English proficiency (LEP), exacerbating healthcare inequities. Consequently, this has the potential for misinterpretations, misdiagnoses, and inappropriate medical interventions. There is an urgent need to provide accessible, culturally sensitive, and language concordant genetic testing and counseling services, especially as results may also carry a direct impact on family members' medical management. This paper underscores the importance of recognizing that the issue extends beyond the availability of genetic testing results; it exemplifies a broader systemic challenge that disenfranchises patients with LEP, limiting their ability to comprehend and engage effectively with their healthcare. This paper advocates for the role of genetic counselors in developing and implementing solutions that bridge the language gap and promote equitable access to genetic healthcare. By leveraging our advocacy skills, genetic counselors can contribute to positive changes that benefit patients with LEP, ensuring that the promise of "Cures" is realized for patients of all linguistic backgrounds.