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The Latest Health Wonk Review


September 12th, 2014

At Health Business Blog, David Williams is not ashamed to be a wonk in his September 11 edition of the Health Wonk Review. David highlights many great posts, including “The 125 Percent Solution,” suggested by Jonathan Skinner, Elliott Fisher, and James Weinstein on Health Affairs Blog, which would give consumers and insurers the option of paying 125 percent of the Medicare price for any health care service.

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New Health Policy Brief: Drug Shortages


September 11th, 2014

A new Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) looks at the ongoing problem of drug shortages in the United States. From 2005 to 2010, the number of reported drug shortages almost tripled.

Today, newly reported drug shortages overall are decreasing, but the total amount of drug shortages continues to increase, reflecting just how long it can take to rectify a shortage. Generic sterile injectable drugs, a vital component for patients fighting cancer, combatting an infection, or about to undergo surgery, are in especially short supply.

One of the most cited reasons for generic sterile injectable drug shortages is low reimbursement rates from Medicare Part B that came about after a change in law in 2003. These changes incentivized both physicians and manufacturers to switch to higher-cost drugs, reducing investment in cheaper generic drugs and causing “growing market concentration,” and eventual drug shortages.

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Implementing Health Reform: Medicaid Eligibility, 2015 Navigator Grants, And FAQs (Updated)


September 8th, 2014

The decision of the full D.C. Circuit to review the panel decision in Halbig v. Burwell en banc was clearly the big Affordable Care Act (ACA) court decision of the first week in September, but a September 2 decision of the federal district court of the Middle District of Tennessee, Gordon v. Wilson, is also worthy of note.

The Medicaid law has long required state Medicaid programs to determine eligibility for Medicaid with “reasonable promptness,” defined by the regulations to mean within 90 days for applicants with disabilities and 45 days for everyone else. Applicants whose applications are not determined reasonably promptly are entitled by the Medicaid law and by the Due Process Clause of the Constitution to a fair hearing.

Medicaid Eligibility and Tennessee

Tennessee, like all states, was required by the ACA to begin calculating Medicaid eligibility for most recipients using modified adjusted gross income, or MAGI as of January 1, 2014. Tennessee attempted to establish a new computer system for doing this, but when it was not ready by January 1, Tennessee asked the federal exchange to determine Medicaid eligibility until it could get its system operational.

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Implementing Health Reform: DC Circuit Vacates Halbig Judgement, Grants Rehearing


September 5th, 2014

On September 4, 2014, the United States Court of Appeals for the District of Columbia granted a request by the government for a rehearing en banc (by the full court) in Halbig v. Burwell.  A divided three judge panel in the Halbig case had held on July 22, 2014 that an Internal Revenue Service rule allowing federally facilitated exchanges to grant premium tax credits was invalid. The D.C. Circuit’s decision to hear the case en banc vacated the panel’s judgement.

On the same day the Halbig panel decision was released, a three-judge panel of the Fourth Circuit Court of Appeals in Richmond, Virginia, had unanimously upheld the rule.  The conflicting decisions resulted in dueling petitions for review.  The plaintiffs in the King case petitioned the Supreme Court for certiorari, asking the Court to reverse the Fourth Circuit decision and hold the IRS rule invalid.  The government, on the other hand, petitioned the D.C. Circuit for a rehearing en banc.

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Projected Slow Growth In 2013 Health Spending Ahead Of Future Increases


September 3rd, 2014

Insurance Coverage, Population Aging, and Economic Growth Are Main Drivers of Projected Future Health Spending Increases

New estimates released today from the Office of the Actuary at the Centers for Medicare and Medicaid Services project a slow 3.6 percent rate of health spending growth for 2013 but also project a 5.6 percent increase in health spending for 2014 and an average 6.0 percent increase for 2015–23. The average rate of projected growth for 2013–23 is 5.7 percent, exceeding the expected average growth in gross domestic product (GDP) by 1.1 percentage points.

Increased insurance coverage via the Affordable Care Act (ACA), projected economic growth, and population aging will be the main contributors of this growth, ultimately leading to an expected 19.3 percent health share of nominal GDP in 2023, up from 17.2 percent in 2012.  This compares to the Office of the Actuary’s 2013  report, published in Health Affairs, predicting an average growth rate of 5.8 percent for 2012–22.

Every year, the Office of the Actuary releases an analysis of how Americans are likely to spend their health care dollars in the coming decade. The new findings appear as a Health Affairs Web First article and will also appear in the journal’s October issue.

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Integrity In Retail Health Care: Rethinking The Sale Of Tobacco Products


September 3rd, 2014

Retail health care is a relatively new development in American health care.  It is true that much of the dispensing of medications has historically occurred through retail pharmacies, which sold a variety of other goods and services, but somehow that was not seen as the provision of health care.   Health care institutions, including doctors’ offices, hospitals and clinics, were the places that people went to be diagnosed and treated.  And those institutions did little other than health care; they did not, and still do not today, offer any products other than provision of care, including testing and treatment.  As such, these institutions demonstrated high integrity, defined as a state of being whole, and synonymous with cohesion and unity of purpose.

Now retail pharmacies, mass merchandisers and grocery stores are adding “health care” as another consumer good to be purchased on a mass scale.  Retail health care is in some cases, extending what the pharmacist does in the retail pharmacy: providing more advice about a variety of health care issues, giving vaccines, and working more closely with doctors’ offices.  In other cases, it is the opening of small clinic practices, often staffed by nurse practitioners, caring for minor ailments.  These kinds of clinics make great sense from the point of view of convenience and cost and have proven to be very popular, particularly given the shortage of convenient primary care that exists in many communities.

There are signs that the scope of retail health is deepening.  Pharmacies are planning to do more laboratory testing, in part to support a broader array of health advice from pharmacists, and in part to allow a wider set of complaints to be addressed in the retail pharmacies.  Walgreens has developed accountable care organizations with hospital partners.  At CVS Health, we have been very public about our effort to align with integrated delivery systems to help them manage population health by emphasizing joint efforts to improve medication adherence, support the management of complex patients, and create direct electronic medical record connectivity between our 900 retail clinics and the doctors’ offices.  Just last month, Walmart announced that their new clinics would be primary care offices, capable of caring for a range of chronic disease.

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Transcending Obamacare? Analyzing Avik Roy’s ACA Replacement Plan


September 2nd, 2014

Avik Roy’s proposal, “Transcending Obamacare,” is the latest and most thoroughly developed conservative alternative for reforming the American health care system in the wake of the Affordable Care Act. It is a serious proposal, and it deserves to be taken seriously.

Roy’s proposal is a curious combination of conservative nostrums (limiting recoveries for victims of malpractice), progressive goals (eliminating health status underwriting, providing subsidies for low-income Americans), and common sense proposals (enacting a uniform annual deductible for Medicare).

Most importantly, however, Roy proposes that conservatives move on from a single-minded focus on repealing the ACA toward building upon the ACA to accomplish their policy goals. He supports repealing certain features of the ACA—including the individual and employer mandate—but would retain others, such as community rating and exchanges. As polling repeatedly shows that many Americans are not happy with the ACA, but that a strong majority would rather amend than repeal it, and as it is very possible that we will have a Congress next year less supportive of the ACA than the current one, Roy’s proposal is important.

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Implementing Health Reform: Tax Form Instructions


August 29th, 2014

On August 28, 2014, the Internal Revenue Service re-released the draft forms that will be used by employer, insurers, and exchanges for reporting Affordable Care Act tax information to individuals and to the IRS for 2014 and 2015, as well as the instructions for completing those forms.  The IRS also released in the Federal Register requests for public comments on three of those forms — the 1094-Bthe 1094-C, and the 1095-C — under the Paperwork Reduction Act.  This post reports on these forms and instructions and on a guidance released by the Centers for Medicare and Medicaid Services.

The tax forms had been published earlier and are described in an earlier post.  The instructions for the forms, however, had not been available and had been eagerly awaited by employers, insurers, exchanges, and tax professionals. Forms 1094-C and 1095-C will be used by large employers with more than 50 full-time or full-time-equivalent employees to determine whether the employer is responsible for penalties under the employer shared responsibility requirements of the ACA.  They will also be used to determine whether employees have received an affordable and adequate offer of coverage, rendering them ineligible for premium tax credits.  Employers are required to provide each full-time employee with a form 1095-C and to file each of these together with a transmittal form 1095-B form with the IRS.

The instructions for the 1094-C and 1095-C are by far the most complex of the instructions released on August 28, filling 13 pages with dense, two column, print.  Most of the complexity derives from the options for complying with the employer mandate and the transition exceptions to that mandate that the administration has created.  These alternatives and exceptions were explored in my posts on the employer mandate final rule when it was issued in February, 2014.  These forms are also complicated by the fact that the IRS decided to allow self-insured large employers to file only the large employer 1094-C and 1095-C, rather than requiring them to also fill out the 1094-B and 1095-B forms, which are filed by other entities that provide minimum essential coverage.  Because the employer mandate has been delayed, large employers are not required to file these forms for 2014, although they may do so voluntarily.

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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

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

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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