Clinical Therapeutics/Volume 37, Number 4, 2015

Editorial Implementing the Affordable Care Act: Remaining Hurdles Passed along political party lines, the Patient Protection and Affordable Care Act (ACA) was signed into law in March 2010. The ACA is being implemented in stages, with 2014 marking the Act’s most important milestone as federal and state exchanges began offering insurance coverage to previously un- and underinsured individuals. Critics suggest the ACA is a divisive piece of legislation. Nonetheless, the Act contains 2 major provisions on which there is some semblance of consensus: the expansion of insurance coverage for dependants up to age 26 years, and the requirement that insurance companies cover all applicants and offer the same premium rates irrespective of preexisting conditions or sex. Other provisions have proven to be far more controversial. These provisions include the ACA’s main vehicle, to increase health insurance coverage by expanding Medicaid. Correspondingly, the ACA has Joshua P. Cohen, PhD established federal and state exchanges on which people can buy policies while receiving income-based subsidies to help cover the costs of premiums. The latest Supreme Court legal challenge (King v Burwell) argues that subsidies cannot be granted to federal exchanges, as the law stipulates that subsidies are to be allocated to state exchanges. The ACA’s imposition of individual and employer mandates continues to draw the ire of critics. Detractors suggest that such mandates restrict freedom of choice and the functioning of a competitive health insurance market. Paradoxically, the mandates were designed to enable the health insurance market to better pool risks and therefore to function more optimally. Specifically, to prevent state-exchange insurers from being subjected to the problem of adverse selection—which would lead to disproportionate numbers of beneficiaries with high health care costs enrolling in exchanges—the ACA levies a penalty for individuals who elect not to purchase insurance. Additionally, to maintain current levels of employer-provided coverage, businesses with Z50 employees that do not offer health insurance will incur a financial penalty, starting in 2016. Now that the ACA is law, it is time for a progress report. In this theme issue, contributors evaluate some of the opportunities and challenges facing ACA implementation.


The ACA’s raison d’être is to improve patients’ access to health care. In 2014, the first full year of operation of the federal and state exchanges, the number of uninsured Americans decreased. One estimate suggests that the number of uninsured declined by as much as 25% (10 million people) in 2014.1 In addition, large numbers of insurers have chosen to join the ACA exchanges, which has expanded consumer choices and allowed for a greater pooling of risks. In 41 states, the number of insurers rose by 26% in 2014, while in 19 states the number of products offered through the ACA increased by two thirds.2 Meanwhile, the median cost of insurance premiums is Scan the QR Code with your phone to obtain FREE ACCESS to the articles featured in the Clinical Therapeutics topical updates or text GS2C65 to 64842. To scan QR Codes your phone must have a QR Code reader installed.

April 2015


Clinical Therapeutics rising at a slower rate than prior to the enactment of the legislation.3 In addition, in the past few years, the overall rate of growth of health care costs has been decreasing. Although it is too soon to attribute this decrease to the ACA, the decrease does suggest a possible correlation between the ACA and a bending of the cost curve.


In this issue of Clinical Therapeutics, Beland et al4 draw our attention to political and legal resistance to the law at both the federal and state levels, in addition to explicit attempts to undo the ACA. Depending on how the Supreme Court rules in King v Burwell in June 2015, the US government may no longer be able to provide subsidies in the 32 states that have not set up their own insurance exchanges. Without these subsidies, a large number of Americans would not be able to afford health insurance, and the entire system could collapse. Legal issues aside, major hurdles remain, namely, to: (1) get more uninsured people to sign up through employer and individual mandates; (2) ensure quality, affordable access; and (3) make the overall health care system more efficient and better coordinated.

New Enrollees

In this issue, Dubois5 offers a cautionary tale about the net numbers of newly insured. He notes that while the law has added to the tally of newly insured individuals, it has also subtracted an unknown number of people from the insurance rolls. In particular, some individuals who had insurance prior to the roll-out of the ACA are no longer insured because their previous coverage does not meet the regulatory standards imposed by the law. Furthermore, policymakers are concerned about the law’s potentially negative impact on employer-sponsored insurance. Yet current data suggest that despite a decline in employer-sponsored coverage between 2000 and 2012, numbers appear to have leveled off in 2013 and 2014, postponement of the employer mandate notwithstanding.6 To subsidize the benefits of the newly insured sick—whom insurers must cover under the law—a large pool of young, healthy individuals need to enroll. Although the individual mandate is seen as a policy measure effective for increasing enrollment, it has been criticized as imposing an especially harsh financial burden on young, healthy individuals who have no immediate need for insurance. It is thought that the cost/benefit calculation could lead to young, healthy individuals deciding to pay the penalty in lieu of coverage. Nonetheless, signs point to a substantial number of young individuals enrolling.7 As tax returns are filed in 2015, we will know more about how many have complied with the individual mandate.

Quality, Affordable Access Keys to the success of the ACA are the provision of an adequate level of health care benefits, affordable premiums and deductibles, as well as limited patient cost-sharing. The articles in this issue of Clinical Therapeutics by Dubois5 and Schoonveld et al8 demonstrate that relatively high patient cost-sharing (especially for drugs) may undermine the objective of affordability. Additionally, as Gee et al9 demonstrate in a case study, the ACA is a necessary but insufficient condition for improved access to progesterone for pregnant women with Medicaid insurance. Hospital and pharmacy availability needs to be ensured in addition to reduced patient costsharing.

Efficiency and Coordination Despite the recent indications of tempered growth in health care costs, perhaps the greatest challenges will be to continue to contain costs and to better coordinate care across and within health care sectors. Providing insurance to millions more people will increase the use of health care services, which implies more spending. The law includes measures meant to slow the growth of health expenditures, from hospital care to pharmaceuticals. For example, payments to Medicare and to providers, including physicians and hospitals, will be reduced. Also, certain Medicare providers will be paid for the treatment of a disease or conditions as a whole (“episodes of care”, analogous to diagnosis-related group payments) rather than for individual procedures. In addition, a tax will be imposed on health insurance plans offering overly generous coverage.


Volume 37 Number 4

Editorial Schoonveld et al8 offer advice for the biopharmaceutical industry in the face of a changing environment in which the focus is on value and not volume. Policy challenges loom, such as how to optimally replace fee-forservice payment with a new payment system focused on producing value yet maintaining innovation. The jury is out on whether these measures will have a sustained impact in terms of cost containment, coordination of health care, and improved outcomes. Joshua P. Cohen, PhD Tufts Center for the Study of Drug Development Boston, MassachusettsTufts Center for the Study of Drug DevelopmentBostonMassachusetts

REFERENCES 1. Sanger-Katz M. Is the Affordable Care Act working? New York Times. is-the-affordable-care-act-working.html?_r=0#/. October 27, 2014. 2. McKinsey & Company. 2015 Open Enrollment Period: Emerging trends in the individual exchanges. com/sites/default/files/2015%20OEP%20Emerging%20Trends%20-%20McK%20Reform%20Center_0.pdf. Accessed February 2, 2015. 3. Collins SR, et al. The Commonwealth Fund. “Gaining Ground: Americans’ Health Insurance Coverage and Access to Care After the Affordable Care Act’s First Open Enrollment Period”. /media/files/publications/ issuebrief/2014/jul/1760_collins_gaining_ground_tracking_survey.pdf. July, 2014. 4. Beland, et al. Polarized Stakeholders and Institutional Vulnerabilities: The Enduring Politics of the Patient Protection and Affordable Care Act. Clin Ther. 2015;37:720–726. 5. Dubois. The Affordable Care Act: How Can We Know Whether the Intended Consequences Are Occurring and the Unintended Ones Are Being Avoided? Clin Ther. 2015;37:747–750. 6. 2014 Employer Health Benefits Survey. Kaiser Family Foundation. Accessed February 2, 2015. 7. ASPE Issue Brief, HHS, 2014; Department of Health and Human Services. “How many individuals might have marketplace coverage after the 2015 open enrollment period”? November, 2014. 8. Schoonveld, et al. Impact of ACA on the Dinner-for-Three Dynamic. Clin Ther. 2015;37:733–746. 9. Gee et al, et al. 17α-Hydroxyprogesterone Caproate Access in the Louisiana Medicaid Population. Clin Ther. 2015;37:727–732.

April 2015


Implementing the affordable care act: remaining hurdles.

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