Pharmacoepidemiology of testosterone: Impact of reimbursement policy on curbing off-label prescribing.

OBJECTIVES: To estimate the impact on testosterone prescribing over 3 years following the 2015 tightening of Pharmaceutical Benefits Scheme (PBS) criteria. DESIGN: Analysis of testosterone prescribing data from PBS and private (non-PBS) sources between 2012 and 2018 covering 2015 change in PBS prescribing criteria. MAIN OUTCOME MEASURES: New and total PBS testosterone prescriptions estimating usage by quarter analyzed by product type, patient age-group, indication and prescriber type. Total national testosterone prescriptions (private plus PBS) was verified from an independent data supplier (IQVIA). RESULTS: PBS usage peaked in 2014 declining by 30% in 2017-8 with PBS prescribing covering a fall from 97.6% by usage in 2014 to 74% in 2017-18 of all testosterone prescribing. The tighter 2015 PBS restrictions sustained the selective reduction in GP initiation of prescriptions for middle-aged men without pathological hypogonadism whereas specialist initiations and prescription for adult hypogonadism or pediatric/prepubertal indications were largely unaffected. CONCLUSIONS: The tightening of PBS criteria from 1 April 2015 to curb off-label prescribing remained effective and selective over 3 years yet total national testosterone prescribing continued with little change, reflecting a shift to private prescriptions. The continuation of off-label testosterone prescribing for unproven indications suggests that long-term androgen dependence is created in men without pathological hypogonadism who commence testosterone. This highlights the need to avoid prescribing testosterone to men without pathological hypogonadism in the absence of sound evidence of efficacy and safety, the latter including the little unrecognized risks of long-term androgen dependency when trying to quit.

Moving Pharmacy Benefits from Nice to Have to Essential Benefits.

DISCLOSURES: No funding supported the writing of this commentary. The authors have nothing to disclose.

Autism Insurance Mandates in the US: Comparison of Mandated Commercial Insurance Benefits Across States.

INTRODUCTION: Autism mandates are laws that require commercial insurers to cover certain evidence-based treatments for Autism Spectrum Disorder (ASD). The purpose of this study was to review state variability in autism insurance mandates and the benefits they cover and to discuss recommendations for research and policy to improve ASD services across states. METHODS: Data were extracted from 2001 to 2020 from all 50 states plus the District of Columbia (N = 51) from policy text. News articles and websites of ASD advocacy organizations were also reviewed to ensure inclusion of the most recent policy changes. Descriptive statistics and heatmaps were used to characterize the autism mandate landscape and visualize variability in benefit parameters across states. RESULTS: Autism mandates vary greatly in benefit parameters across US states, but there is a common set of benefits that most states have adopted. These include coverage of provider-recommended ASD services except for medical equipment, coverage up to an age limit of 18 to 21, an annual dollar limit of $36,000 with no restriction on the number of hours or visits, no lifetime cap on benefits, and requirement of BCBA® certification or its equivalent for providers of ABA. DISCUSSION: There is a need for continued research evaluating the impact of autism mandates and benefit parameters on access to care, service utilization, and clinical outcomes for the ASD population. Stakeholder engagement and understanding the impact of autism mandates on clinical and patient-centered outcomes may provide direction for policy advocacy and public health initiatives.

The Secretary Shall . . . : Implementing the Affordable Care Act's Private Insurance Expansions.

The federal bureaucracy played a critical role in implementing most aspects of the Affordable Care Act's private insurance coverage expansion. Through brief case studies, the authors review three dimensions of this role: the development of the Center for Consumer Information and Insurance Oversight, rulemaking in the formulation of the essential health benefits package, and the implementation of the federal website. They relate these to themes in the public administration literature. Politics-both through state decisions and through continuing congressional action (and inaction)-pervaded the implementation process. The challenges of staffing and situating the new bureaucracy effectively changed vertical boundaries within the Department of Health and Human Services, with long-lasting consequences. Finally, the complex design of the policy itself made passage of the legislation easier but implementation much more difficult. Ultimately, however, implementation was remarkably successful, achieving improvements in coverage consistent with the Congressional Budget Office's projections.

Immediate Postpartum Long-Acting Reversible Contraception Programs in Texas Hospitals Following Changes to Medicaid Reimbursement Policy.

OBJECTIVES: Provision of long-acting reversible contraception (LARC) after delivery and prior to discharge is safe and advantageous, yet few Texas hospitals offer this service. Our study describes experiences of Texas hospitals that implemented immediate postpartum LARC (IPLARC) programs, in order to inform the development of other IPLARC programs and guide future research on system-level barriers to broader adoption. METHODS: Eight Texas hospitals that had implemented an IPLARC program were identified, and six agreed to participate in the study. Interviews with 19 key hospital staff covered (1) factors that led the development of an IPLARC program; (2) billing, pharmacy, and administrative operations related to implementation; (3) patient demand and readiness; (4) the consent process; (5) staff training; and (6) hospital plans for monitoring and evaluation of IPLARC services. RESULTS: Most hospitals in this study primarily served Medicaid and un- or under-insured populations. Participants from all six hospitals perceived high levels of patient demand for IPLARC and provider interest in providing this service. The major challenges were related to financing IPLARC programs. Participants from half of the hospitals reported that leadership had concerns about financial viability of providing IPLARC. The hospitals with the longest-running IPLARC programs were safety net hospitals with family planning training programs. CONCLUSIONS FOR PRACTICE: We found that hospitals with IPLARC programs all had strong support from both providers and hospital leadership and had funding sources to offset costs that were not reimbursed. Strategies to reduce the financial risks related to IPLARC provision could provide the impetus for new programs to launch and support their sustainability.

Perspectives on Opportunities and Challenges for Medicare Advantage Plans to Address Social Determinants of Health via the CHRONIC Care Act.

There is increasing recognition of the role of social determinants of health (SDOH) in the ability of Medicare Advantage (MA) enrollees to obtain needed care. The 2018 CHRONIC Care Act established Special Supplemental Benefits for the Chronically Ill (SSBCI), which for the first time gives MA plans the flexibility to provide supplemental benefits to enrollees to address SDOH. Given the role of SDOH in chronic disease, this represents an opportunity for MA plans to address underlying issues not strictly health care related with which MA enrollees struggle and that affect their overall health. MA plans have experimented with different approaches to address SDOH but have been limited by the lack of ability to offer services as part of covered benefits and reliance on partnerships, grants, and other funding sources to support the provision of these services. The effect of this policy and how it may evolve before implementation begins in 2020 remains uncertain as we wait to see how MA plans will interpret eligibility criteria and services offered without any additional allotted funding.

Pharmacy Benefit Managers: Practices, Controversies, and What Lies Ahead.

Issue: Pharmacy benefit managers (PBMs) are responsible for negotiating payment rates for a large share of prescription drugs distributed in the U.S. Recently, policymakers have expressed concern that certain PBMs' business practices may not be consistent with public policy goals to improve the value of pharmaceutical spending. Goal: We sought to explain key controversies related to PBM practices and their roles in driving value in the pharmaceutical market. Methods: Literature review and feedback from top experts on PBM business practices and potential policy solutions. Key Findings and Conclusion: In some cases, PBMs' use of rebates has contributed to high pharmaceutical costs, yet proposed solutions to the rebate controversy--including passing the rebate through to payers or patients--will not on their own reduce overall pharmaceutical spending without other policies that drive toward value. Policymakers seeking to reform pharmaceutical reimbursement beyond the practice of rebates will need to consider these changes in light of the recent mergers between PBMs and insurers and the entry of new market competitors.

Black Lung Benefits Act: Medical Benefit Payments. Final rule.

This final rule revises the regulations under the Black Lung Benefits Act (BLBA or Act) governing the payment of medical benefits and maintains the level of care available to miners. The final rule establishes methods for determining the amounts that the Black Lung Disability Trust Fund (Trust Fund) will pay for covered medical services and treatments provided to entitled miners. The Department based the rule on payment formulas that the Centers for Medicare & Medicaid Services (CMS) uses to determine payments under the Medicare program, which are similar to the formulas used by other programs that the Office of Workers' Compensation Programs (OWCP) administers. The Department is adopting these payment formulas for the black lung program because they more accurately reflect prevailing community rates for authorized treatments and services than do the internally-derived payment formulas that OWCP currently uses. In addition, the final rule eliminates two obsolete provisions.

Federal Employees Health Benefits Program and Federal Employees Dental and Vision Insurance Program: Expiration of Coverage of Children of Same-Sex Domestic Partners; Federal Flexible Benefits Plan: Pre-Tax Payment of Health Benefits Premiums: Conforming Amendments. Final rule.

On October 30, 2013, OPM published final regulations in the Federal Register to expand coverage for children of same-sex domestic partners under the Federal Employees Health Benefits (FEHB) Program and the Federal Employees Dental and Vision Insurance Program (FEDVIP). The regulation allowed children of same-sex domestic partners living in states that did not allow same-sex couples to marry to be covered family members under the FEHB and the FEDVIP. Due to a subsequent Supreme Court decision legalizing same-sex marriage in all states, OPM published an interim final regulation on December 2, 2016, that created a regulatory exception that only allowed children of same-sex domestic partners living overseas to maintain their FEHB and FEDVIP coverage until September 30, 2018. OPM recognized that there were additional requirements placed on overseas federal employees that did not apply to other civilian employees with duty stations in the United States making it difficult to travel to the United States to marry their same-sex partners. Understanding that we have provided agencies with additional time for compliance given that overseas federal employees may not have been able to marry immediately following the Supreme Court decision, OPM is issuing a final rule removing references to domestic partners and domestic partnerships from the regulations. Based on the Supreme Court decision and the two additional year's lead time for domestic partners overseas to marry, the current language in the CFR is not needed and may be somewhat confusing. There is no change in coverage for children whose same-sex partners are married.

Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2019. Final rule.

This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters; and user fees for Federally-facilitated Exchanges and State Exchanges on the Federal platform. It finalizes changes that provide additional flexibility to States to apply the definition of essential health benefits (EHB) to their markets, enhance the role of States regarding the certification of qualified health plans (QHPs); and provide States with additional flexibility in the operation and establishment of Exchanges, including the Small Business Health Options Program (SHOP) Exchanges. It includes changes to standards related to Exchanges; the required functions of the SHOPs; actuarial value for stand-alone dental plans; the rate review program; the medical loss ratio program; eligibility and enrollment; exemptions; and other related topics.

Behavioral Health Coverage In The Individual Market Increased After ACA Parity Requirements.

As of January 1, 2014, the Affordable Care Act designated mental health and substance use services as an essential health benefit in Marketplace plans and extended parity protections to the individual and small-group markets. We analyzed documents for seventy-eight individual and small-group plans in 2014 (after parity provisions took effect) and sixty comparison plans in 2013 (the year before parity provisions took effect) to understand the degree to which coverage for mental health and substance use care improved relative to medical/surgical benefits. The results suggest that plan issuers did what the provisions required them to do. Although in 2013 a lower proportion of plans covered mental health or substance use care, compared to medical/surgical care, in 2014 the proportions were the same. If essential health benefit requirements were to be removed and mental health and substance use coverage becomes similar to that in 2013, as many as 20 percent of the plans in our sample would not cover these conditions. To determine whether increases in behavioral health coverage will result in improved access to behavioral health services requires complementary data on the size of provider networks and use of services.

Reimbursement of Qualifying Adoption Expenses for Certain Veterans. Interim final rule.

The Department of Veterans Affairs (VA) amends its regulation to provide for reimbursement of qualifying adoption expenses incurred by a veteran with a service-connected disability that results in the inability of the veteran to procreate without the use of fertility treatment. Under the Continuing Appropriations and Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2017, and Zika Response and Preparedness Act, VA may use funds appropriated or otherwise made available to VA for the "Medical Services" account to provide adoption reimbursement to these veterans. Under the law, reimbursement may be for the adoption-related expenses for an adoption that is finalized after the date of the enactment of this Act under the same terms as apply under the adoption reimbursement program of the Department of Defense (DoD), as authorized in DoD Instruction 1341.09, including the reimbursement limits and requirements set forth in such instruction. This rulemaking implements the new adoption reimbursement benefit for covered veterans.