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State-Based Marketplaces: Leveraging Year-One Lessons To Boost Year-Two Enrollment


August 27th, 2014

In three months, consumers will log onto their state’s health insurance marketplace to investigate their options and enroll in a plan. Already, states are hard at work prepping for the second year of open enrollment, which begins November 15. State marketplaces are expected to increase the number of enrollees this year and adopting lessons from 2013-2014 can help.

A User-Friendly Marketplace

First and foremost, states need a user-friendly marketplace that functions properly and allows consumers, brokers, insurers and navigators to seek and provide information that is timely and credible. States know this, but recently, interviews with 100 staff from five successful state-based marketplaces (SBMs) unearthed several less obvious lessons.

To begin, states should move from last year’s ‘shotgun’ marketing that helped build awareness to a more targeted approach to outreach this year. In addition to some mass marketing to maintain awareness, states should target advertising dollars to high-priority segments and focus on less expensive tools, like direct mailing campaigns and walk-up enrollment centers, which proved to be most effective last year.

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Rescue Me: The Challenge Of Compassionate Use In The Social Media Era


August 27th, 2014

The Development of Brincidofovir and its Possible Use to Treat Josh Hardy

Last March 4, seven-year old Josh Hardy lay critically ill in the intensive care unit at St Jude Children’s Hospital in Memphis, Tennessee with a life-threatening adenovirus infection. His weakened immune system was unable to control the infection, a complication of a bone marrow stem cell transplant he needed as a result of treatments for several different cancers since he was 9 months old.

His physicians tried to treat the adenovirus with an anti-viral agent, Vistide (IV cidofovir), but had to stop due to dialysis-dependent renal failure. They were aware of another anti-viral in Phase 3 clinical development, brincidofovir, an oral compound chemically related to Vistide. In earlier clinical testing brincidofovir had shown the potential for enhanced antiviral potency and a more favorable safety profile.

Chimerix (where one of us, Moch, was CEO), a 55 person North Carolina-based biopharmaceutical company, had previously made brincidofovir available to more than 430 critically ill patients in an expanded access program for the treatment of serious or life-threatening DNA viral infections, including adenovirus as well as herpes viruses (such as cytomegalovirus) and polyomaviruses.  This program started in 2009 as a series of individual physician-sponsored emergency INDs — investigational new drug exemptions issued in physician-certified compassionate use situations.

The program evolved via word of mouth to the extent that brincidofovir was made available under emergency INDs for more than 215 patients. During 2011, Chimerix received funding from Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA) to provide brincidofovir to an additional 215 critically ill patients for the purpose of gaining insights into the potential use of brincidofovir as a medical countermeasure against smallpox. (Department of Health and Human Services Contract No. HHSO100201100013C.  For further information on brincidofovir Study CMX001-350, see ClinicalTrials.gov Identifier NCT01143181.)

When BARDA funding ended in 2012, Chimerix stopped accepting new requests for compassionate use under its expanded access program. Although requests continued from physicians around the world, the company decided that it was in the best interests of the greatest number of patients to devote its limited human and financial resources to the clinical development pathway necessary for FDA approval of brincidofovir.

This post examines the implications of the ultimately successful campaign waged by Josh Hardy’s family to obtain access to brincidofovir for their son. We discuss several issues raised by the Hardy case, including the overarching question of whether it is fair for social media or influence of any form to play a role in determining which patients get access to experimental treatments; whether rescuing individual patients in need can be reconciled with an evidence-based regulatory approval process for new therapies; and whether there is a duty to “rescue” terminally ill patients by paying for access to experimental therapies.

Finally, we propose a new framework for regulating access to experimental treatments.

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The 125 Percent Solution: Fixing Variations In Health Care Prices


August 26th, 2014

Summer vacation’s finally here. You’re strolling along the beach, not a care in the world when – ouch – you step on a piece of broken glass and need a few stitches at the local hospital. Such routine procedures are painless enough, but depending on where you’re treated and by whom, the real pain could occur when you’re handed the ER bill.

In some of the latest evidence on the crazy-quilt patterns of U.S. health care prices, Castlight Health found prices in Dallas TX ranging from $15 to $343 for the same cholesterol test.  What makes these price variations particularly egregious is that the highest prices are typically reserved for those least able to pay, such as the uninsured.

What’s the solution?  In the long run, we need to establish a more transparent system where consumers can choose easily based on reliable quality and price measures.  But our current measures of quality are, to put it politely, inadequate, and people with insurance are often insulated or can generally afford those higher prices.  Reference pricing, in which insurance pays only enough to reimburse providers with adequate quality and relatively lower costs, would help to restrain high prices, but distracted patients or those with strong attachments to specific doctors or hospitals could still get stung with a big bill.

Capping payments at 125 percent of Medicare rates. We suggest a short-term solution: The federal Medicare program has in place a complete system of prices for every procedure and treatment.  It’s not perfect, but it is uniform across regions, with a cost-of-living adjustment that pays more in expensive cities and less in rural areas.  If every patient and every insurance company always had the option of paying 125 percent of the Medicare price for any service, we would effectively cap the worst of the price spikes.  No longer would the tourist checked out at the ER for heat stroke be clobbered with a sky-high bill.  Nor would the uninsured single mother be charged 10 times the best price for her child’s asthma care.  This is not just another government regulation, but instead a protection plan that shields consumers from excessive market power.

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The “Failure” Of Bundled Payment: The Importance Of Consumer Incentives


August 21st, 2014

Bundled payment for orthopedic and spine surgery and other major acute interventions has many attractive features, in principle. But implementation has been difficult in practice.  The recent Health Affairs paper by Susan Ridgley and colleagues, and the Health Affairs Blog commentary by Tom Williams and Jill Yegian, list quite a few practical implementation problems, and the points raised in both these pieces are well taken.

As leaders in the Integrated Health Association (IHA) bundled payment initiative, we shared the same hopes, devoted the same energies, and share the same frustrations with the modest results.  We feel it is important to emphasize what we consider to be the initiative’s most important design failure: the lack of engagement and alignment on the part of the consumer.  No one will ever reform the U.S. health care system without bringing the consumer along and, indeed, placing consumer choice and accountability at the very center of the reform initiative.

On an optimistic note, this design failure is being addressed by the larger health care marketplace in the wake of numerous failed attempts to reform health care by focusing exclusively on provider payment and incentives.

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Implementing Health Reform: Medicare And The ACA Marketplaces (Updated)


August 12th, 2014

On August 1, 2014, the Centers for Medicare and Medicaid Services released a set of frequently asked questions on the relationship between Medicare and the marketplaces. This is not the first guidance CMS has published on this topic, and much of the information in the FAQ was already available. The FAQ is also quite repetitive, as it answers the same questions under different headings, such as “general enrollment FAQs” and “consumer messaging,” but does contain useful information. This post briefly summarizes the FAQ.

The FAQ emphasizes the fact that Medicare and marketplaces operate independently, with little overlap. The marketplaces do not enroll individuals in Medicare or in Medicare Advantage plans and do not sell Medicare supplement plans. Indeed, exchanges cannot legally sell coverage to Medicare beneficiaries.

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Implementing Health Reform: Transferring Information Among The Exchanges, The IRS, And Taxpayers


August 8th, 2014

For better or worse, Congress decided to use our tax system and the Internal Revenue Service to operationalize two of the most important features of the Affordable Care Act (ACA): the premium tax credits that make coverage affordable to many lower and moderate-income Americans and the individual responsibility provision which ensures that healthy as well as unhealthy Americans obtain health coverage.

The tax credits are available to otherwise uninsured Americans with incomes between 100 and 400 percent of the federal poverty level. For 2014, tax credits are being received by 85 percent of marketplace enrollees and are reducing their premiums in the federally-facilitated exchanges by 76 percent.

The individual mandate is enforced through a tax that will be imposed on Americans who do have minimum essential coverage—such as employment-based coverage, individual coverage, or coverage through a government program—and who do not qualify for an exemption. For 2014, these individuals will owe a tax for each month that they lack minimum essential coverage of 1/12th of $95 per adult and $47.50 per child (up to $285 for a year) or 1 percent of their income above the tax filing limit up to the average annual cost of bronze plan ($2,448 per individual up to $12,240 for families of five or more).

In a recent post on Health Affairs Blog, Jon Kingsdale and Julia Lerche offered an excellent analysis of some of the difficulties that may be encountered during the 2014 tax filing season. In another post I described briefly recently released 2014 tax forms, as well as further guidance on tax matters. This post examines how tax reporting and filing will be handled in greater detail.

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Having A Baby: Media Confusion Over Charges, Costs, And The Benefits Of Insurance


August 6th, 2014

Note: In addition to Marc Berk, Claudia Schur also coauthored this post. 

Recent discussion about the Affordable Care Act has intensified the media’s interest in the cost of medical care. While as health services researchers we are perhaps in the best position to provide information on complex health care topics, we may need to improve our ability to distill information into one minute sound bites.

A particularly interesting example of the disconnect between media reporting and a more nuanced analysis occurred earlier this year, on March 4, when NBC ran a story about the cost of having a baby. The story confused the very different concepts of what health care providers charge, what they are actually paid, and what consumers owe, and in so doing obscured one of the key benefits for consumers of being insured.

We were startled to hear that, according to NBC, the cost of having a baby has increased more than 300 percent in the past 10 years. According to the report, the cost of a vaginal delivery went from $7,700 to $32,000, while the cost of a cesarean birth went from $11,000 to $51,000. A small heading in the table presented by NBC cited Truven Analytics as the source of these data.

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An Ounce Of Prevention For The ACA’s Second Open Enrollment


August 4th, 2014

Note: In addition to Jon Kingsdale, this post is coauthored by Julia Lerche.

Since recovering from its flawed rollout, the ACA has enjoyed a string of successes. By April, some eight million Americans managed to enroll; for 2015, some reluctant insurers, including the nation’s second largest (United), are jumping into the new ACA Marketplaces; and the New England Journal of Medicine recently published an analysis confirming the ACA’s significant reduction of the uninsured.

Approximately 87 percent of Marketplace enrollees claimed premium tax credits, of which an estimated 85 percent, or six million, actually paid premiums. (We assume a disenrollment rate of 3 percent per month since April 2014, which is conservative compared with the Massachusetts Health Connector’s experience and in line with the assumptions of several State-based Marketplaces.) Many of the original six million, plus more recent enrollees, will experience their second enrollment between November 15, 2014 and February 15, 2015. They will also file with the IRS for a premium tax credit as early as January 2015.

The two events in combination represent a huge risk. We hope the responsible agencies will act soon to mitigate the risks.

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Individual Patient Expanded Access: Developing Principles For A Structural And Regulatory Framework


July 31st, 2014

Editor’s note: In addition to Meaghan George, Sara Bencic and Darshak Sanghavi also coauthored this post. 

Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development process is granted to patients on a case-by-case basis outside of a clinical trial, prior to completion of mandated clinical trials and approval by the Food and Drug Administration (FDA). This typically involves filing a single patient or emergency investigational new drug (IND) request with the Food and Drug Administration and voluntary release of the drug by the manufacturer.

Generally, the following criteria must be met: there is reasonable expectation of meaningful benefit despite the absence of definitive clinical trial data, the patient has a serious or life-threatening condition, there are no comparable or satisfactory treatment alternatives, and there are no suitable clinical trials for the drug available to the patient. This form of expanded access, which is the focus of this paper, is different from the situation in which a drug is discharged to a large group of needy patients in the interval between successful phase 3 trials and presumed FDA approval, a strategy often termed a “treatment” IND or protocol, which was initially used in the 1980s for releasing zidovudine to patients with acquired immune deficiency syndrome.

A Call to Action: The Importance of Expanded Access Programs

The Engelberg Center for Health Care Reform at the Brookings Institution recently invited senior leaders from several pharmaceutical companies, two bioethicists, a senior FDA representative, and a patient advocate to share experiences and discuss organizational strategies related to expanded access (see acknowledgements). A driving factor for this meeting was a recent flurry of highly public cases of desperate patients seeking access to experimental drugs, which lead to social media campaigns and media coverage.

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Taking Stock Of The ACA: The Latest Data From The Health Reform Monitoring Survey


July 29th, 2014

Editor’s note: In addition to Sharon Long, this post is coauthored by Genevieve Kenney, Stephen Zuckerman, and Katherine Hempstead. 

Since early last year, the Urban Institute’s Health Reform Monitoring Survey (HRMS) has been collecting relevant, timely data that is providing insights on the implementation of the ACA and changes in health insurance coverage and related outcomes. (An article describing the survey was published in Health Affairs last December.)

Beginning in late 2013, the HRMS set the stage by exploring adults’ understanding of key ACA provisions, their level of health insurance literacy, and expectations about coverage changes in 2014 based on information collected just before the beginning of the first open enrollment period. More recently, the HRMS has shed light on the characteristics of the newly insured, identified who’s not shopping for insurance, and explained how some states’ decisions to expand Medicaid has reduced uninsurance rates.

The HRMS and other surveys have confirmed that the number of uninsured adults has declined significantly since the first open enrollment under the ACA started. On Tuesday July 29th 2014, Health Affairs Editor-in-Chief Alan Weil moderated a panel discussion on what the HRMS shows about the ACA’s performance thus far and what it implies for next year’s open enrollment period. (A recording is available for those who couldn’t join live.) At the event, we released three new policy briefs that, respectively, provide the latest detailed coverage estimates, describe the remaining uninsured, and explore how consumers are navigating the ACA’s Marketplaces.

Here’s a sample of what we’ve learned from this latest release of HRMS data and what was covered at today’s event:

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Implementing Health Reform: IRS Releases Premium Tax Credit Rules And Draft Forms


July 25th, 2014

Although the focus of activity the week of July 21 was in the courts, the agencies were not totally silent. On July 24, 2014 the Internal Revenue Service released final and temporary and proposed regulations addressing issues that are presented by the premium tax credit program. The IRS also released drafts of the forms that individuals, insurers, and employers will use for reporting information to the IRS necessary for reconciliation of premium tax credits and for the enforcement of the individual and employer mandate programs. Finally, the IRS set the maximum individual mandate penalty for individuals whose income is high enough that they pay the penalty as a percentage of income rather than a flat dollar amount. This amount is established by the statute as the average cost of a bronze level plan for the applicable family size for 2014 and was set by the IRS at $2,448 per individual annually, up to $12,240 for families of five or more.

The draft forms operationalize the reporting requirements established by rules published earlier. Insurers and self-insured health plans will provide a Form 1095-B to each of their enrollees and members, and file these forms, together with a transmittal form 1094-B with the IRS. Large employers must provide a form 1095-C to each employee, and transmit these, together with a transmittal form 1095-B to the IRS. Exchanges will provide their enrollees a form 1095-A. Individuals who receive premium tax credits will file a form 8962 with the IRS, while individuals claiming an exemption from the individual mandate will file a form 8965. Though the forms are not accompanied by instructions, they are quite straightforward and track closely the earlier released rules.

The final and temporary rules address several situations that will arise under the premium tax credit program that have not yet been addressed by the premium tax credit rules. The temporary rules are identical to the proposed rules and will cease to apply once the proposed rules are finalized.

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Implementing Health Reform: Appellate Decisions Split On Tax Credits In ACA Federal Exchange


July 23rd, 2014

July 22, 2014 was arguably the most important day in the history of the implementation of the Affordable Care Act since the Supreme Court issued its ruling in the National Federation of Independent Business case in June of 2012. As no doubt most readers of this blog know by now, shortly after 10 a.m. the United States Court of Appeals for the District of Columbia Circuit handed down its decision in Halbig v. Burwell. Two judges ruled over a strong dissent that an Internal Revenue Service rule allowing federally facilitated exchanges to issue premium tax credits to low and moderate income Americans is invalid.

Approximately two hours later the Fourth Circuit Court of Appeals in Richmond, Virginia, unanimously upheld the IRS rule in King v. Burwell. Combined, the cases contain five judicial opinions, three in the Halbig case and two in King. Four of the six judges voted to uphold the rule, two to strike it down.

The Controversy

The issue in the cases is this: The ACA authorizes the IRS to provide premium tax credits to individuals with household incomes between 100 and 400 percent of the federal poverty level who are not eligible for other minimum essential coverage (such as affordable and adequate employer coverage, Medicaid, or Medicare). Premium tax credits are, however, only available to individuals who purchase coverage through the exchanges.

The ACA requests that the states establish exchanges, and sixteen states and the District of Columbia have done so. The ACA also, however, authorizes the federal government to establish exchanges in states that fail to set up their own exchanges. The federal government has done so in 34 states and is operating the individual exchange for two more. The IRS regulation allows premium tax credits to be awarded to eligible individuals in both states with state-operated exchanges and states with federal exchanges.

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Health Policy Brief Updates


July 22nd, 2014

In the first half of 2014 Health Affairs has released seven new Health Policy Briefs and also has provided updates of five previously released briefs, in order to reflect continuously changing and evolving health policy issues and perspectives.

The following Health Policy Briefs were updated in 2014:

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Implementing Health Reform: Hobby Lobby Response, The ACA In The Territories, And More


July 18th, 2014

July 17, 2014 was a remarkably active day in an otherwise quiet week for Affordable Care Act implementation. First, the Departments of Labor, Treasury, and Health and Human Services issued their first response to the Supreme Court’s Hobby Lobby decision —a Frequently Asked Question (FAQ) guidance requiring ERISA plans to provide notice to their participants and beneficiaries if they do not intend to cover contraceptives. Second, the Department of Health and Human Services sent letters to the territories (the Virgin Islands, Northern Mariana Islands, Guam, American Samoa, and Puerto Rico) informing them that insurers that market individual insurance policies in the territories are no longer required to comply with the ACA’s insurance market reforms.

Third, HHS released an enrollment bulletin at its REGTAP website describing how insurers in the federally facilitated exchange should handle enrollment for 2015 for individuals whose coverage was terminated in 2014 for non-payment. This post describes these issuances, as well as the May Medicaid enrollment report released on July 11, 2014 by HHS

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Income Verification On The Exchanges: The Broader Policy Picture


July 14th, 2014

The Affordable Care Act scandal de jour (or at least one of them) is the difficulty the exchanges have faced in verifying the eligibility of many premium tax credit applicants. Two Department of Health and Human Services Office of Inspector General Reports in early July documented the existence of these problems. One reported that as of the first quarter of 2014, the federal exchange alone had been unable to resolve 2.6 or 2.9 million data inconsistencies. Another reported that internal controls at the federal and two state exchanges were not fully effective in ensuring that individuals enrolled in exchanges were in fact eligible.

House Republicans claim that in fact there are 4 million data inconsistencies affecting half of all enrollments. In House Energy and Commerce hearings on June 10, 2014, Republican Representative Charles Bustany Jr. claimed that $44 billion in improper payments would be made over the next 10 years. Douglas Holtz-Eakin, a former Bush Administration official, who testified at the hearings claims that improper payments may equal $152 billion. The House Energy and Commerce Health Subcommittee is holding further hearings on data inconsistencies on July 16.

The seriousness of verification issues should not be overestimated. The administration has been put in place procedures to verify carefully premium tax credit applications. Many of the discrepancies CMS is attempting to resolve do not relate to income eligibility, and those that do may result ultimately in a finding of eligibility for increased, rather than decreased, premium tax credits. A discrepancy that could result in the need for additional documentation may be as trivial as a hyphen left out of a name or a digit transposed on a Social Security number.

Unfortunately, programs proposed by Republicans and other ACA opponents that in fact make a serious attempt to cover the uninsured will require income reporting and face similar difficulties. Current reform proposals that avoid coverage eligibility determinations will not in fact cover the uninsured. While the administration could have perhaps done a better job in making eligibility determinations, any means-tested program faces a similar challenge. It is possible to design a system that does not rely on means testing and could cover low-income and high-cost uninsured Americans, as I describe below. But it would be a very different system than the ACA or alternatives currently being proposed.

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Recent Health Policy Brief: E-Cigarettes And Federal Regulation


July 11th, 2014

The latest Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) describes federal policy makers’ recent efforts to propose rules for e-cigarette regulation. E-cigarettes, virtually non-existent ten years ago, have skyrocketed in popularity, including among people who claim to use e-cigarettes as a tool to help them quit smoking altogether.

The 2009 Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration (FDA) authority to oversee the manufacture, marketing, distribution, and sale of regulated tobacco products such as cigarettes, tobacco in cigarettes, roll-your-own, and smokeless tobacco. But it left unregulated other tobacco products such as cigars, pipe and hookah tobacco, nicotine gels, and e-cigarettes.

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A Health Reform Framework: Breaking Out Of The Medicaid Model


July 10th, 2014

Editor’s note: This post is coauthored by Joseph Antos and James Capretta.

A primary aim of the Patient Protection and Affordable Care Act (ACA) is to expand insurance coverage, especially among households with lower incomes. The Congressional Budget Office (CBO) projects that about one-third of the additional insurance coverage expected to occur because of the law will come from expansion of the existing, unreformed Medicaid program. The rest of the coverage expansion will come from enrolling millions of people into subsidized insurance offerings on the ACA exchanges — offerings that have strong similarities to Medicaid insurance.

Unfortunately, ample evidence demonstrates that this kind of insurance model leaves the poor and lower-income households with inadequate access to health care. The networks of physicians and hospitals willing to serve large numbers of Medicaid patients have been very constrained for many years, meaning access problems will only worsen when more people enroll and begin using the same overburdened networks of clinics and physician practices.

It does not have to be this way. It is possible to expand insurance coverage for the poor and lower-income households without reliance on the flawed Medicaid insurance model. Opponents of the ACA should embrace plans to replace the current law with reforms that would give the poor real choices among a variety of competing insurance offerings, including the same insurance plans that middle-class families enroll in today. Specifically, we propose a three-part plan that includes a flexible, uniform tax credit for all those who lack employer-based coverage; deregulation of Medicaid; and improved safety-net primary and preventive care.

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After Hobby Lobby: How Might Policymakers Mitigate The Decision’s Impact On Women And Families?


July 3rd, 2014

Editor’s note: In addition to Sara Rosenbaum, Adam Sonfield and Rachel Benson Gold also coauthored this post. 

On June 30, the U.S. Supreme Court handed down a ruling that has the potential to undermine an important provision of the Affordable Care Act (ACA) that establishes for women a federal guarantee of coverage for their full range of contraceptive methods, services, and counseling without any out-of-pocket costs. This guarantee is administered through private health plans, whether purchased in the individual market or made available through the insurers and plan administrators that provide group coverage.

The 5-4 ruling in Burrell v. Hobby Lobby Stores, written by Justice Samuel Alito on behalf of the Court’s conservative bloc, held that closely held for-profit corporations that assert a religious objection to some or all forms of contraception cannot be required to include such coverage in the health plans they sponsor for employees and their families. As emphasized by Justice Ruth Bader Ginsburg in her dissent (joined in whole by Justice Sotomayor and in part by Justices Kagan and Breyer), the Court’s decision could have serious and widespread consequences.

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Implementing Health Reform: Exchange Eligibility Redeterminations; Small Employer Tax Credit


June 27th, 2014

While it seems like the 2014 open enrollment period just ended, the 2015 open enrollment period, which begins on November 15, is in fact only four and a half months away. On June 26, 2014, the Department of Health and Human Services released a proposed rule addressing eligibility redeterminations for 2015. Together with the proposed rule, HHS issued a guidance describing how the federally facilitated exchange intends to redetermine eligibility, as well as draft standard notices for health plans to use when discontinuing or renewing plans in the individual and small group market and instructions for completing those notices.

On the same date, the Internal Revenue Service released final rules governing the small employer tax credit program. This post will discuss these rules and guidances, as well as another court decision rejecting a challenge to the individual mandate and another spate of FAQs on the SHOP exchange program.

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Do Insurance Marketplace Consumers Need More Doctor Choices In-Network, Or Just Better Information?


June 26th, 2014

Media outlets have focused extensively on consumer complaints about “limited networks” and not being able to find a doctor under qualified health plans (QHPs) offered through the Health Insurance Marketplaces (HIMs). In response, the Obama administration released new standards which will require all QHPs to contract with a larger proportion of essential community providers within its service area. This means that health plans will be forced to accept more health care providers within their network, which may potentially increase costs for consumers.

At the heart of the recent changes lies a fundamental question worth exploring: Is consumer satisfaction with, and perceptions of health plan “network adequacy” grounded in the number of choices for doctors within network, or is it something different?

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