Safe Step Act: does it undermine step therapy?

Drug expenditure in the United States has continued to increase unsustainably; the specialty of dermatology has been particularly affected. Resources are limited - someone has to make decisions about what treatments will be covered and how they will be reimbursed. Step therapy is a cost-control method used by insurers to encourage the use of the most cost-effective treatments before more expensive options are attempted. However, a rigid step therapy policy can be problematic when protocols are out of date, or delay necessary treatment leading to unnecessary suffering, increased morbidity, and overall cost. To address some of these concerns, the proposed Safe Step Act (S. 2546 and H.R. 2279) attempts to create a requirement that insurers provide a transparent, expeditious exceptions process for step therapy protocols. Increased flexibility in this process will allow for the unique circumstances of individual patients and improve access to expensive drugs for special cases. However, this bill may be exploited, further weakening insurers' ability to negotiate on cost. We should be cautious about measures that reduce the effectiveness of this tool, particularly if we, as a society, aim to expand access to basic care to all Americans.

States as Policy Laboratories: The Politics of State-Based Single-Payer Proposals.

Although the focus for most single-payer advocates is in Washington, DC, and on proposals for Medicare for all, there are also efforts in a handful of states to enact a state-based single-payer program. Moreover, the odds of legislative passage are better in a state like New York than at the federal level.Even if enacted, however, state-based single-payer proposals face a distinct set of obstacles, including (1) the need to obtain federal permission (via waivers) to repurpose federal dollars, (2) the federal Employee Retirement Income and Security Act, and (3) the burden of state-only action in an interconnected 50-state economy.The most likely result of the energized single-payer movement will be incremental public insurance expansions at the federal and state levels, including state programs to permit the uninsured to buy into the Medicaid program. Such an outcome is consistent with the most plausible path (incrementalism) to a US version of universal coverage.

The Affordable Care Act, remedy, and litigation reform.

The Patient Protection and Affordable Care Act of 2010 (ACA) rewrote the law of private health insurance. How the ACA rewrote the law of civil remedies, however, is a question largely unexamined by scholars. Courts everywhere, including the U.S. Supreme Court, will soon confront this important issue. This Article offers a foundational treatment of the ACA on remedy. It predicts a series of flashpoints over which litigation reform battles will be fought. It identifies several themes that will animate those conflicts and trigger others. It explains how judicial construction of the statute's functional predecessor, the Employee Retirement Income Security Act of 1974 (ERISA), converted a protective statute into a uniquely effective piece of federal litigation reform. Ultimately, it considers whether the ACA--which incorporates, modifies, and rejects ERISA in several notable ways--will experience a similar fate.

ERISA Reform as Health Reform: The Case for an ERISA Preemption Waiver.

If federal health reforms continue to rely on employer-sponsored health care coverage, ERISA preemption reform should be part of the next steps. State-level reform has acquired greater urgency, while the justifications for preempting that source of reform has eroded. This article recommends a statutory waiver for ERISA preemption as a feasible way to adapt to these circumstances. It offers proposed statutory text for reformers inclined to pursue ERISA reform as health reform.

Local health care initiatives--ERISA preemption of State Health Care Reform-Health Insurance-Fair Share Act. Golden Gate Restaurant Association v. City and County of San Francisco, 512 F.3d 1112 (9th Cir. 2008).

A state or local ordinance is not preempted by ERISA if it does not bind plan administrators to structure plans in a certain way or mandate that they provide specific benefits to employees. A local law could be preempted if it contains specific provisions relating to ERISA, or the operation of the law itself depends upon ERISA.

There's "private" and then there's "private": ERISA, its impact, and options for reform.

The Employee Retirement Income Security Act of 1974 (ERISA), a federal law regulating private employer-sponsored employee benefit plans, was primarily designed for pension plans, but has had a profound impact on state health care reform efforts. ERISA's broad preemption language has been judicially interpreted to preclude states from most forms of regulation of employer health plans, including benefit design (except through regulation of insurance products) and incorporating employer expenditure requirements in state health reform financing. But since 1974, Congress has never seriously returned to reexamine several fundamental questions: Should employers be required to offer or contribute to employee health coverage? Should ERISA preempt state efforts to take such actions? Or should ERISA incorporate more comprehensive regulation of health plans in these areas? Although the politics of ERISA preemption have thus far blocked federal reform, while allowing state reform activity to be simultaneously curtailed, new health reform efforts may force Congress to address these questions.

The conflict between ERISA and local healthcare reform.

In 2007, two different federal courts held that the Employee Retirement Income Security Act (ERISA) pre-empts some version of pay-or-play laws enacted in Maryland and New York. ERISA continues to complicate the states' ability to include employers in efforts to reform health coverage financing.