The Ryan White HIV/AIDS Program: Thirty Years of Addressing Health Disparities.

The Ryan White HIV/AIDS Program is a unique federal program to provide HIV care, treatment, and support services for people living with HIV in the United States. Through the distinctive structure of the program that allows for addressing both medical needs and some of the social determinants of health that can pose barriers to accessing care, the program has been instrumental in improving outcomes for people with HIV with documented improvement in HIV viral suppression and decreased disparities in that outcome over the past decade. To reach the goal of ending the HIV epidemic in the U.S., the program must expand services to people with HIV who are not regularly engaged in medical care.

Pharmacy Benefit Managers in the Eye of the Storm: Growing Multipartite Scrutiny.

The high cost of prescription drugs in the U.S. remains an ongoing national challenge. A recurring focal point in discussions over this distressing steady state is the role(s) played by Pharmacy Benefit Managers (PBMs) who negotiate drug prices with pharmaceutical manufacturers, conduct drug utilization reviews, engage in disease management, and see to formulary creation. At their inception, the multiple newly established PBMs were arguably intent on constraining the rise of prescription drug prices. At the time of this writing, however, the lion share of a far less competitive PBM market is controlled by CVS Caremark, Express Scripts, and OptumRx. It is this evolving reality which could be interpreted to mean that the PBMs may have become part of the problem, rather than part of the solution. Expanded scrutiny of the PBMs by Federal and State authorities as well as by Professional Medical Associations must not be delayed with an eye toward affording the public with relief from the high cost of prescription drugs.

Lawsuits Over the Price of Insulin-State Efforts for Insulin Access.

This Viewpoint discusses the litigation strategy of state-initiated lawsuits alleging illegal and immoral conduct regarding the pricing of insulin by pharmaceutical companies and pharmacy benefit managers.

Medicare Advantage: Growth Amidst Mounting Scrutiny.

The Medicare Advantage Program, home to nearly half of the eligible Medicare population, has recently come under increased scrutiny. The Government Accountability Office called on the Centers for Medicare & Medicaid Services to monitor "disenrollment of MA beneficiaries in the last year of life, validate MA-provided encounter data, and strengthen audits used to identify and recover improper payments to MA plans." The House Subcommittee on Oversight and Investigations of the Committee on Energy & Commerce, dedicated a hearing to "Protecting America's Seniors: Oversight of Private Sector Medicare Advantage Plans." In addition, a recently conducted audit of the Office of the Inspector General of the Department of Health and Human Services raised concerns over "denials of prior authorization requests" and "beneficiary access to medically necessary care." In this article we consider the backdrop for the growing scrutiny of the MA program and the implications thereof to its future trajectory.

Maternal Mortality Crisis and Extension of Medicaid Postpartum Coverage.

This Viewpoint discusses the maternal mortality crisis in the US, the need for an extension of Medicaid postpartum coverage, and the residual challenges across the US related to maternal health.

Affirmative Action Ruled Unconstitutional: Options for Building a Diverse Health Care Workforce.

This Viewpoint reviews how the recent US Supreme Court decision regarding affirmative action affects extant medical school admission policies seeking to enhance diversity of the national medical student body and its derivative national health care workforce.

The New Threat to Abortion Access in the United States-The Comstock Act.

This Viewpoint explains the history of the Comstock Act, its use by those seeking to restrict abortion, and why it threatens abortion access in the US.

REI clinics and fellowship training-a national snapshot to improve access to reproductive care.

PURPOSE: To analyze the geographic distribution of REI fellowships and clinics across the USA and to strategize ways to improve patient access to care. METHODS: Cross-sectional study using population data obtained from publicly available United States Census Bureau, Society for Assisted Reproductive Technology (SART), and National Resident Matching Program websites. Outcomes include the number of REI clinics, REI fellowship-trained physicians, and REI fellowship programs. RESULTS: In 2020, there were 643 assisted reproductive technology (ART) clinics reporting to SART and 1351 fellowship-trained REI physicians. Most clinics are located in the south (n = 209); however, the northeast has the highest density of REI clinics. Out of 301,316 in vitro fertilization (IVF) cycles in the USA in 2020, northeastern states initiated the most cycles (n = 93,565), and Midwestern states initiated the fewest cycles (n = 50,000). The northeast has the most REI physicians per million women aged 20-44 years (42.4) while the Midwest has the lowest ratio (19.5). There are fewer REI physicians per million women aged 20-44 years in states with a lower proportion of patients with health insurance (r = 0.56, 95% confidence interval ([CI] 0.34-0.73) and in states with a lower average income per resident (r = 0.65, 95% CI 0.46-0.79). Most of the 49 accredited REI fellowship programs in the USA are in the northeast (n = 18), and there are fewest in the south (n = 10) and west (n = 10). CONCLUSION: Access to REI care has large geographic disparities from a clinic, physician, and training program perspective. Creative solutions are needed to remedy this problem.

Pediatric Drug and Other Shortages in the Age of Supply Chain Disruption.

This Viewpoint lists the top 3 pediatric drugs and product shortages, considers the federal government's and manufacturers' ethical duty to protect children, reviews the causes for the shortages, and suggests policy changes that could help fill in the gap.

The FDA Initiative to Assure Racial and Ethnic Diversity in Clinical Trials.

On April 13, 2022, the Food & Drug Administration (FDA) issued a new draft guidance for industry for "developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S. into clinical trials ." In so doing, the FDA reaffirmed the reality that racial and ethnic minorities remain underrepresented in clinical trials. FDA Commissioner Robert M. Califf, MD offered that the "U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health." Commissioner Califf went on to pledge that "achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities." This Commentary is dedicated to a thorough review of the new FDA policy and the implications thereof.

Association of Participation in the Maryland Primary Care Program With COVID-19 Outcomes Among Medicare Beneficiaries.

Importance: Advanced primary care is a team-based approach to providing higher-quality primary care. The association of advanced primary care and COVID-19 outcomes is unknown. Objective: To evaluate the association of advanced primary care with COVID-19 outcomes, including vaccination, case, hospitalization, and death rates during the first 2 years of the COVID-19 pandemic. Design, Setting, and Participants: This retrospective cohort study used Medicare claims data from January 1, 2020, through January 31, 2022, and Maryland state vaccination data. All Part A and B Medicare claims for Maryland Medicare beneficiaries were included. The study population was divided into beneficiaries attributed to Maryland Primary Care Program (MDPCP) practices and a matched cohort of beneficiaries not attributed to MDPCP practices but who met the eligibility criteria for study participation from January 1, 2020, through December 31, 2021. Eligibility criteria for both groups included fee-for-service Medicare beneficiaries who were eligible for attribution to the MDPCP. A forced-match design was used to match both groups in the study population by age category, sex, race and ethnicity, Medicare-Medicaid dual eligibility status, COVID-19 Vulnerability Index score, Maryland county of residence, and primary care practice participation. Exposures: Primary care practice participation in the MDPCP. Main Outcomes and Measures: Primary outcome variables included rate of vaccination, monoclonal antibody infusion uptake, and telehealth claims. Secondary outcomes included rates of COVID-19 diagnosis, COVID-19 inpatient claims, COVID-19 emergency department claims, COVID-19 deaths, and median COVID-19 inpatient admission length of stay. Claims measures were assessed from January 1, 2020, through October 31, 2021. Vaccination measures were assessed from January 1, 2020, through March 31, 2022. Results: After matching, a total of 208 146 beneficiaries in the MDPCP group and 37 203 beneficiaries in the non-MDPCP group were included in this study, comprising 60.10% women and 39.90% men with a median age of 76 (IQR, 71-82) years. Most participants (78.40% and 78.38%, respectively) were White. There were no significant demographic nor risk measure baseline differences between the 2 groups. The MDPCP beneficiaries had more favorable primary COVID-related outcomes than non-MDPCP beneficiaries: 84.47% of MDPCP beneficiaries were fully vaccinated, compared with 77.93% of nonparticipating beneficiaries (P < .001). COVID-19-positive beneficiaries in MDPCP also received monoclonal antibody treatment more often (8.45% vs 6.11%; P < .001) and received more care via telehealth (62.95% vs 54.53%; P < .001) compared with nonparticipating counterparts. In terms of secondary outcomes, beneficiaries in the MDPCP had lower rates of COVID-19 cases (6.55% vs 7.09%; P < .001), lower rates of COVID-19 inpatient admissions (1.81% vs 2.06%; P = .001), and lower rates of death due to COVID-19 (0.56% vs 0.77%; P < .001) compared with nonparticipating beneficiaries. Conclusions and Relevance: These findings suggest that participation in the MDPCP was associated with lower COVID-19 case, hospitalization, and death rates, and advanced primary care and COVID-19 response strategies within the MDPCP were associated with improved COVID-19 outcomes for attributed beneficiaries.

Pharmacy Benefit Managers and the Federal Trade Commission: A Relationship Gone Sour.

This Viewpoint provides a brief history of pharmacy benefit managers (PBMs), describes the ways in which PBMs have acquired influence in the prescription drug distribution system, and suggests possible scenarios surrounding the June 2022 decision by the Federal Trade Commission to launch an investigation into PBM business practices.

A New Approach to Cancer Bundled Payments in Medicare-The Enhancing Oncology Model.

This Viewpoint describes the new voluntary Center for Medicare and Medicaid Innovation Enhancing Oncology Model for cancer bundled payments, explores its likelihood of success, and discusses potential shortcomings.

Assessing-and Extending-California's Insulin Manufacturing Initiative.

This Viewpoint reviews California's recently proposed CalRx initiative to manufacture biosimilar insulin, highlights challenges facing the initiative, and suggests ways in which, if successful, the initiative could serve as a model for state-managed development of drugs other than insulin, reduce drug prices, and provide other benefits.