From Then Until Now: A Top-Down View Of The Affordable Care Act.

How does the Patient Protection and Affordable Care Act (ACA) of 2010 differ from the act as it stands today? Many changes have occurred, in Medicaid expansion, private insurance coverage, the American Health Benefit Exchanges, and the individual mandate.

Beyond Medical Cannabis: Considerations for Updates to Hospital Policies and Procedures.

As marijuana legalization and use expands across the U.S., health care systems are struggling to keep abreast of the changes and trends in regulations. Considering marijuana's federal illegality and other restrictions on its use, the limited evidence for its clinical efficacy, and the myriad psychological adverse events, caution is recommended when establishing policies and procedures regarding coverage of marijuana and CBD products.

As Health Care Landscape Shifts, Stakeholders Need To Shift as Well.

Change is happening on multiple fronts and at a faster pace than ever before. Stakeholders that ignore or minimize it will do so at their peril. To be clear, addressing organizational change or purpose internally, as well as external positioning today, is the more likely path to success.

Regulatory and Legislative Disparities With Cannabis Present Challenges to P&T Committees and Health Care Providers.

Increased cannabis use has brought about a sea change in policy and attitudes toward regulation, and a multitude of rules that vary widely between states. The disparity has stymied any effective response to the problems surrounding access to cannabis products for those in need. Health care providers and practitioners, as well as P&T committees, must carefully undertake decisions on rational drug use, whether or not their patients are using cannabis while under their care.

Forensic Analysis in Drug Litigation Finds Most Errors Occur with Commonly Used Therapies and Practices.

In the complex setting of obstetrics and reproductive medicine, the medication-related injuries leading to the most litigation involve some of the most commonly used drugs, rather than the newer, more complicated therapies. The authors present a number of cases illustrating how sophisticated treatment of high-risk pregnancies can be jeopardized by a simple negligent act.

Use of Regulations, Laws, Standards, and Best Practices When Prosecuting and Defending Hospitals in Drug Injury Lawsuits.

The authors underscore the importance of understanding standards and procedures as they discuss two lawsuits that arose from drug injury.

Challenges to the U.S. Health Care System From Legal and Regulatory Changes in the Donald Trump Era.

Despite a slow legislative start by President Trump, new federal and state regulatory health care changes will have important implications for pharmacists, P&T committees, and patients.

Sterile Compounding Needs Risk Management: Access, Reconstitution Or Preparation, and Administration.

Appropriate risk management strategies must be employed for compounding and administering sterile products. We review the new credentialing, regulatory, and related legal aspects of gaining and maintaining compliance for these processes.

Regulatory Change Versus Legislation Impacting Health Care Decisions and Delivery.

Despite the president's urging, congressional efforts to repeal the Patient Protection and Affordable Care Act (PPACA) have been repeatedly unsuccessful. The authors explore key actions taken by the administration and department heads that have resulted in delayed enforcement of the PPACA and relaxation of the law.

Focusing on Basics, Including Drug-Use Policy, Remains Important for Today's P&T Committee.

Over the past few years, P&T committees have been evolving to deal with care at expanding sites within an organization, across a larger system, or involving multiple organizations. The authors consider one aspect of this expansion-medication system failures-that requires the attention of P&T policy.

PBM P&T Practices: The HEAT Initiative Is Gaining Momentum.

The pharmacy benefit management (PBM) industry has recently fallen into the crosshairs of government investigations about the high cost of pharmaceuticals. The authors focus on the PBM-based P&T and formulary practices under scrutiny.

Systemic Market and Organizational Changes: Impact on P&T Committees.

The authors consider market stakeholder consolidation, market-driven efficiency demands, consumerism, and legal enforcement of patient rights related to access to appropriate drugs and posit how future P&T committees may approach these issues.

A Review of US Drug Costs Relevant to Medicare, Medicaid, and Commercial Insurers Post-Affordable Care Act Enactment, 2010-2016.

Since passage of the Affordable Care Act (ACA) in 2010, US stakeholders are increasingly being held accountable for the value of healthcare services and drugs administered to patients. Pharmacoeconomic analyses offer one method of demonstrating a product's value, yet there is a lack of resources specific to US drug costs relevant to each stakeholder. The aim of this study was to review current US drug costs (post-ACA). A literature review aimed at finding evidence on outpatient prescription drug costs was performed using the following sources: PubMed, governmental agencies, news websites, the Academy of Managed Care Pharmacy (AMCP) website, and Google Scholar. Articles were limited to those published in the years "2010-2016" and the "English" language, and those that described drug acquisition costs, reimbursement costs, and rebates or discounting for Medicare, Medicaid, and commercial payors. The Drug Cost Focus Group (DCFG) was convened to supplement the literature review; the DCFG provided their expertise on US drug costs and emerging issues affecting drug costs. ACA legislation increased drug rebates for manufacturers participating in the Medicaid Drug Rebate Program. Acquisition costs commonly referred to in the literature include the wholesale acquisition cost and average manufacture price. Drugs reimbursed by Medicaid are currently based on the actual acquisition cost and ACA-Federal Upper Limit. Evidence suggests that reimbursement methods in the public market are varied. Current gaps in the literature regarding commercial insurers' drug costs (post-ACA) present barriers to the application of relevant drug costs to pharmacoeconomic analyses.