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Adult Conversation On High-Priced Drugs? Don’t Hold Your Breath (But Hang In There) …


October 27th, 2014

The benevolent identity of the health care enterprise tends to moderate disagreements and keep them under a big tent of shared goals. In the case of very high prices for powerful new drugs, however, the commons gets stretched painfully thin. Drug companies which see themselves as pioneers are accused of being merely greedy. Cost-conscious payers and regulators are impugned for depriving patients of life-conserving treatment breakthroughs. A divisive political undercurrent often threatens to obtrude. Altogether, a tough environment for rational policy assessment.

Credit is due, accordingly, to the Brookings Institution, for putting a wide array of views on display at its October 1 forum on “the cost and value of biomedical innovation,” which was jointly sponsored by the Schaeffer Center at the University of Southern California. With the head of Gilead Sciences at one pole of the discussion and a leading generics industry attorney at the other, the discussion didn’t lack for strongly-held views, strongly stated.

But the tone was civil, a lot of useful information was exchanged, and the audience went away carrying a meta-message about the importance of maintaining an “adult conversation” on a subject of such obvious importance and difficulty.

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Implementing Health Reform: The Qualified Health Plan Federal Exchange Participation Agreement And More


October 21st, 2014

CMS continues to put the pieces into place that are needed for the launch of the 2015 coverage year.  On October 16, 2014, the Centers for Medicare and Medicaid Services released at its REGTAP.info website the certification agreement and privacy and security agreement that qualified health plan (QHP) insurers must sign with CMS to access the federally facilitated exchange (FFE), the federally facilitated SHOP (FF-SHOP), and CMS Data Services Hub.  The agreement focuses primarily on obligations that the QHP insurer undertakes to protect personally identifiable information and to ensure secure communications with CMS, although it also addresses the effective date and termination of the agreement and a few other issues.  Most of the terms of the agreement are unremarkable, and this post will only comment on a few.

QHP insurers undertake under the agreement to protect personally identifiable information and to ensure secure communications with CMS in conformity with applicable laws, regulations, and standards.  They must also ensure that their contractors and downstream entities comply with these requirements.  QHP insurers agree to report any personally identifiable information incidents or breaches to CMS within 72 to 96 hours.  This is a far cry from the one-hour breach reporting requirement proposed by CMS last year but never finalized, but perhaps recognizes the difficult of identifying and assessing a security breach.

The agreement expressly recognizes that QHP insurers have developed their products based on the assumption that advance premium tax credits and cost-sharing reduction payments will be available through the marketplace and that QHP insurers could have cause to terminate the agreement if this assumption ceases to be valid.  This could be interpreted as a reference to the Halbig/King litigation which currently threatens the availability of tax credits and cost-sharing reduction payments through the FFE, but could also have been included in recognition of the likely Republican takeover of the Senate and the possibility that the Republicans may accomplish through budget reconciliation or otherwise their longstanding goal of repealing the ACA.  As the agreement is renewable from year to year, this clause may contemplate contingencies in the indefinite as well as the near future

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Enrolling College Students In Health Insurance: Lessons From California (Part 2)


October 21st, 2014

Editor’s note: As we approach the beginning of the second open enrollment period under the Affordable Care Act, Walter Zelman describes an effort he led during last year’s initial open enrollment period to enroll students in the California State University (CSU) system in coverage. Part 1 of this post provided background on the CSU system and the enrollment effort, the CSU Health Insurance Education Project, as well as a discussion of what worked well. Part 2, below, addresses what worked less well, as well as project results, lessons and policy implications, and next steps.

In addition to Zelman, authors of this post include Wendy Lee, now in a Masters of Public Health Program at Johns Hopkins; Natasha Buransombati, now in a graduate program in Nursing and Public Health at the University of Seattle in Washington; and Carla Bracamonte, now in an MPH program at California State University, Fullerton. As CSU students, Lee and Buransombati served as regional coordinators for HIEP and Bracamonte served as a coordinator, CSU Los Angeles.

IV.  What Worked Less Well

Assessments as to what did not work must be rendered with caution. In most cases lack of success may have been due to lack of emphasis or time, to the relative inexperience of student educators, or the failure of project leaders to follow-up aggressively with CSU or administrative personnel.

Campus groups, social media, and web pages

Most striking and disappointing, was the difficulty in engaging campus groups. Many seemed supportive of the mission. But, in the end, most were unable to commit time and resources to the project, even after repeated engagement by project representatives. Most campus groups had specific goals and agendas, and promoting insurance coverage to students was not one of them. More time or resources might have produced more campus organization support, but these were not available.

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Enrolling College Students In Health Insurance: Lessons From California (Part 1)


October 20th, 2014

Editor’s note: As we approach the beginning of the second open enrollment period under the Affordable Care Act, Walter Zelman describes an effort he led during last year’s initial open enrollment period to enroll students in the California State University system in coverage. Part 1 below provides background on the CSU system and the enrollment effort, the CSU Health Insurance Education Project, as well as a discussion of what went well. Part 2, which will appear tomorrow, addresses what did not go so well, as well as project results, lessons and policy implications, and next steps.

In addition to Zelman, authors of this post include Wendy Lee, now in a Masters of Public Health Program at Johns Hopkins; Natasha Buransombati, now in a graduate program in Nursing and Public Health at the University of Seattle in Washington; and Carla Bracamonte, now in an MPH program at California State University, Fullerton. As CSU students, Lee and Buransombati served as regional coordinators for HIEP and Bracamonte served as a coordinator, CSU Los Angeles.

The California State University (CSU) system is the largest public university system in the nation, as well as one of the most diverse. The CSU Health Insurance Education Project (HIEP) received a $1.25 million grant to educate students in the CSU system about the Affordable Care Act and health coverage options through California’s new marketplace, Covered California. A pre-open enrollment, multi-campus poll found that approximately 25-30 percent of CSU students were uninsured, primarily because they could not afford insurance.

The project placed student educators on the CSU’s 15 largest campus. Over a seven-month period they gave approximately 1500 classroom presentations, and conducted 70 forums and 300 enrollment events. University administrators sent out over 1 million emails to CSU students. Project strategy emphasized a focus on affordability, the need for insurance (accidents happen), and the simplicity of the enrollment process.

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Health Policy Brief: The Ninety-Day Grace Period


October 17th, 2014

A new Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) examines the ninety-day grace period, a provision of the Affordable Care Act (ACA). Of the eight million people who enrolled in the insurance Marketplaces between October 2013 and March 2014, 85 percent received an advance premium tax credit. This provision allows a three-month grace period for nonpayment of insurance premiums for this group of consumers–and this group only–if they have previously paid at least one month’s full premium in that benefit year.

This grace period allows these new enrollees continuity of care, preventing them from shifting or “churning” in and out of coverage for nonpayment. Health care providers, however, have expressed concerns that this provision and the way the Centers for Medicare and Medicaid Services (CMS) has implemented it could expose them to considerable financial risk. This Health Policy Brief focuses on how this provision is being implemented and the concerns from the provider community.

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Implementing Health Reform: Renewing Coverage For 2015


October 16th, 2014

On October 15, 2014, the Centers for Medicare and Medicaid Services (CMS) announced, with a month to go before the 2015 open enrollment begins on November 15, that it is beginning to send out notices to enrollees in the federally facilitated marketplace (FFM), explaining to them how to renew their coverage for 2015.

CMS is urging consumers to come back to the marketplace as it opens on November 15 to update their 2015 application and to make sure they are enrolled in the qualified health plan (QHP) that best meets their financial situation and health needs for 2015. The procedure outlined in the announcement is that set out in the FFM redetermination guidance issued in June. State-operated exchanges are also, presumably, beginning to inform their enrollees regarding their own 2015 redetermination processes.

Redetermination Notice

FFM Consumers will receive one of six notices. Consumers who visited the marketplace in 2014 and were determined eligible for coverage but who did not enroll, are being sent a notice urging them to return to the marketplace and enroll when the open enrollment period begins. Consumers who enrolled for 2014 but have not been receiving tax credits either because they were not eligible, did not apply, or were determined eligible for tax credits but declined assistance, are urged to return to the marketplace and reenroll in coverage.

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Implementing Health Reform: Reference Pricing And Network Adequacy


October 12th, 2014

On October 10, 2014, the Departments of Labor, Treasury, and Health and Human Services issued a frequently asked question (FAQ) regarding the use of reference-based pricing in non-grandfathered large group employer plans.  Although the issue the FAQ addresses specifically is the use of reference pricing, the FAQ is remarkable insofar as it is the first departmental guidance that I am aware of that addresses the use of networks by self-insured ERISA plans.

Network adequacy is an issue that has long been addressed in the nongroup and insured group market in many states by state insurance law.  The ACA also requires qualified health plans, and arguably any individual and small group plan subject to the essential health benefits requirements, to have adequate provider networks.  Special rules implementing ACA section 2719A of the ACA limit cost-sharing for out-of-network coverage for emergency services.

The departments also stated in an earlier FAQ that cost sharing cannot be applied by any non-grandfathered health plan for preventive services provided by out-of-network providers if the services are not available in network.   But I am unaware of the departments otherwise attempting previously to regulate group health plan network requirements, at least under the ACA.

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Health Affairs Web First: New Study Shows Low-Income Residents In Three States Support Medicaid Expansion


October 9th, 2014

Expansion of Medicaid under the Affordable Care Act (ACA) to millions of low-income adults has been controversial. However, little is known what these Americans themselves think about Medicaid. A new study, recently released as a Web First by Health Affairs, surveyed nearly 3,000 low-income adults in Arkansas, Kentucky, and Texas (states that have adopted different approaches for Medicaid expansion).

This telephone survey, conducted in late 2013, found that 83 percent of respondents in Arkansas and Kentucky and 79 percent of those in Texas were in favor of their state expanding Medicaid under the ACA. Roughly two-thirds of uninsured respondents planned to apply for coverage in 2014. The majority of adults surveyed viewed Medicaid as comparable to or better than private insurance in overall health care quality.

Authors Arnold Epstein, Benjamin Sommers, Yelena Kuznetsov, and Robert Blendon developed a thirty-eight-item survey and targeted citizens ages 19–64 with household incomes of less than 138 percent of the federal poverty level. Forty percent of Texas respondents were Latino. A significant number of respondents (40 percent in Arkansas and Kentucky and 32 percent in Texas) said they were in “fair” or “poor” health, with a substantial number of respondents reporting living with chronic health conditions.

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Health Affairs October Issue: Specialty Drugs — Cost, Impact, And Value


October 6th, 2014

The October issue of Health Affairs, released today, includes a number of studies looking at the high costs associated with today’s increasingly prevalent specialty drugs. Other subjects covered in the issue: an assessment of whether some hospitals may be taking advantage of the 340B drug discount program; a review of how shortened residency shifts impact patient care; a study on the increasing costs associated with Hepatitis C and advanced liver disease; and more.

The new issue will be discussed at a Washington DC briefing tomorrow. This issue of Health Affairs was supported by CVS Health.

Do specialty drugs offer value that offsets their high costs?

James Chambers of Tufts Medical Center and coauthors conducted a cost-value review of specialty versus traditional drugs by analyzing incremental health gains associated with each. This first-of-its-kind analysis is timely because the majority of drugs now approved by the Food and Drug Administration are specialty drugs produced using advanced biotechnology and requiring special administration, monitoring, and handling — all of which result in higher costs.

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An Interview With George Halvorson: The Kaiser Permanente Renaissance, And Health Reform’s Unfinished Business


September 30th, 2014

For decades, health policymakers considered Kaiser Permanente the lode star of delivery system reform.  Yet by the end of 1999, the nation’s oldest and largest group model HMO had experienced almost three years of significant operating losses, the first in the plan’s history. It was struggling to implement a functional electronic health record, and had a reputation for inconsistent customer service.  But most seriously, it faced deep divisions between management and the leadership of its powerful Permanente Federation, which represents Kaiser’s more than 17,000 physicians, over both strategic direction and operations of the plan.

Against this backdrop, Kaiser surprised the health plan community by announcing in March 2002 the selection of a non-physician, George Halvorson, as its new CEO.  Halvorson had spent most of his career in the Twin Cities, most recently as CEO of HealthPartners, a successful mixed model health plan.  Halvorson’s reputation was as a product innovator; he not only developed a prototype of the consumer-directed health plan in the mid-1990’s, but also population health improvement objectives for its membership, both firsts in the industry.

During his twelve year tenure as CEO, Halvorson not only guided the plan to solid profitability, but added a million members in California, its largest market, despite a devastating recession and a national retreat of commercial HMO membership.  He invested over $6 billion in computerized patient care systems and population health management infrastructure, healed the breach with Kaiser’s physicians, and markedly increased its consumer satisfaction scores, earning 5 STAR ratings under Medicare Advantage.  He left the organization at the end of 2013 with more than $53 billion in revenues and more than $19 billion in reserves and investments.

This interview covers Halvorson’s time at Kaiser, his views of health reform, including the unfinished reform agenda, and his public health activism.  It was conducted by Jeff Goldsmith, a veteran health industry analyst, and Associate Professor of Public Health Sciences at the University of Virginia.  Jeff is a member of the editorial board of Health Affairs.

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Implementing Health Reform: Excepted Benefits Final Rule


September 29th, 2014

Congress adopted Title I of the Affordable Care Act to increase access to health coverage for individuals by reforming employer group health coverage and health insurance offered to individuals and groups, requiring large employers to offer their employees affordable minimum health coverage or pay a penalty, imposing a penalty on individuals who can afford health coverage but fail to obtain it, and offering advance premium tax credits through the exchanges to individuals who cannot otherwise afford to purchase health coverage.

Coverage has long been available both through groups and for individuals that provides some health-related benefits but is neither a group health plan nor insured health coverage, as those terms are defined in the ACA.  These benefits were originally labeled by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 as “excepted benefits,” because they are excepted from the forms of benefits regulated initially by HIPAA and now by the ACA.

On September 26, 2014 the Internal Revenue Service, Department of Labor, and the Centers for Medicare and Medicaid Services (“the agencies”) issued regulations expanding access to excepted benefits through insured and self-insured groups.

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How Engaging Patients Can Improve Care And Health Outcomes


September 26th, 2014

Patients and caregivers are gaining momentum as powerful new resources in efforts to improve the health care system. They are increasingly becoming active partners in their own care, as well as seeking to make the health care delivery system more responsive to their needs and easier to navigate. And they are increasingly engaging as collaborators in planning and conducting research, and disseminating its results, with the goal of producing evidence that can help patients and those who care for them make better-informed decisions about the clinical choices they face.

It is this last trend that led the Patient-Centered Outcomes Research Institute (PCORI) to support Health Affairs in developing a series of videos illustrating some of the ways that patients are bringing their unique experiences and community connections to efforts to improve care for themselves and others. This includes stories of how patients are becoming partners in research designed to address the outcomes important to them, taking account of their own concerns and circumstances.

Seen through this lens, being a research partner goes well beyond being the subject of a trial. Rather, it means helping to guide researchers in formulating the questions to be studied, making the right clinical comparisons, looking at appropriate populations, and focusing on the outcomes important to patients. This should greatly increase the chance that the research findings will produce relevant results that can have a real-world impact — something we plan to evaluate carefully over time.

Meaningful patient engagement is at the heart of PCORI’s approach to research, and several of the patients featured in the videos have in fact partnered with researchers in just this way in patient-centered outcomes research (PCOR) studies we fund. They recognize that PCOR, a form of comparative clinical effectiveness research that focuses on issues of concern to patients, is a vital building block for developing truly patient-centered care and health policy, more effective treatments, and better outcomes.

In the following sections, we highlight the projects mentioned in the videos to give you an idea of how patients and community members are partnering in research projects.

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Implementing Health Reform: Complicated ACA Tax Forms Could Cause Problems


September 21st, 2014

In a few months, millions of Americans will be filing either form 8962 to reconcile the advance premium tax credit they received with the tax credit they were actually due, or form 8965 because they owe a tax under the shared responsibility (individual mandate) provision of the Affordable Care Act or claim an exemption from that requirement.

By the close of open enrollment in April, 6.7 million Americans had chosen a qualified health plan with premium tax credits,  and many more have since enrolled in a QHP through a special enrollment period and received tax credits.  Each of them will need to file a form 8962.  The Congressional Budget Office estimates that 30 million Americans are potentially subject to the shared responsibility requirement, and that 23 million of them may qualify for an exemption.  The 7 million individuals who owe the penalty will have to file a form 8965, as will most of the 23 million who claim an exemption.

On September 15, 2014 the Internal Revenue Service released draft instructions for form 8965.  On September 17, 2014, the IRS released draft instructions for form 8962.  It is difficult to overstate how complicated these instructions are.  The tax credit and individual responsibility provisions of the ACA were complicated to begin with, but have become ever more complex as new exceptions and special rules have been created as implementation of the legislation has proceeded.  Many of the mostly low income Americans who will be completing these forms are marginally literate, at least in English, and have been accustomed to filing very simple tax forms like the 1040-EZ (which cannot be used by an individual claiming a tax credit) or perhaps not to filing taxes at all.  They are likely to be confused, frustrated, even angry, and certainly bewildered, completing these forms.  It is to be hoped that most of them will be assisted by well-trained tax preparers.

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Relative Value Health Insurance And Pay For Performance For Insurers: Complements, Not Substitutes


September 19th, 2014

Background

The quest for value dominates contemporary health policy.  Value, properly defined, is not about cost-savings but about the balance of costs and health benefits — improving the average cost-effectiveness of health interventions.  In choosing which care is funded, insurers are a crucial but commonly neglected driver of health system value.

Insurers can increase health system value by covering fewer cost-ineffective interventions or covering more cost-effective interventions.  Perhaps the earliest attempt to reform insurance, managed care, attempted to pursue both goals, but by the time it was implemented it widely focused (or was perceived to focus) on cost-containment.

A recent insurance reform proposal, known as Relative Value Health Insurance (RVHI), received considerable attention, for instance, in The Upshot, The Incidental Economist, and Forbes.  RVHI enables insurers to reduce their contractual obligation to cover “usual and customary” care.  This and similar earlier proposals rely on the insurers’ natural incentive to cut costs.  Less well-covered, however, are proposals to alter the very incentives of insurers to improve health, which we will call “pay-for-performance-for-insurers” (P4P4I).

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Reference Pricing And Network Adequacy Standards: Conflict Or Concord?


September 18th, 2014

With benefit designs and enrollee cost-sharing increasingly standardized across health plans under the Affordable Care Act (ACA), one of the remaining levers plans have to differentiate themselves—and to control premiums—is the size of their provider networks. Regulators have been caught in a crossfire between advocates of narrow networks who say they promote quality and keep prices down, and those who feel narrow networks could constrain access to necessary services.

Unfortunately, recent federal guidance – addressing, among other related items, the issue of “reference pricing” — blurs the distinction between in-network and out-of-network providers and may make it more difficult for regulators and consumers to understand the effective “size” of a particular network.

This confusion could undermine the goal of improving transparency in consumers’ health care choices and make it difficult for consumers to use prices in choosing providers. More troubling, expanded use of “reference pricing” under the guidance could leave patients paying unexpectedly large out-of-pocket amounts for services provided by ostensibly in-network providers.

Below, we characterize reference pricing as a “sub-network” contracting strategy, and we describe some of the implications of reference pricing and the guidance for consumers, regulators, plans, and providers.

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Implementing Health Reform: Resolving Income-Related Data Inconsistencies (Updated)


September 16th, 2014

On September 15, 2014, the Centers for Medicare and Medicaid Services (CMS) announced a second deadline in its efforts to resolve data inconsistencies remaining from the 2014 open enrollment period.  This second deadline is for the submission of documentation to resolve income inconsistencies for exchange enrollees.  The first deadline was announced in August, when CMS sent final letters to about 310,000 federal marketplace (exchange) enrollees whose enrollments raised citizenship or legal-immigrant status issues, informing them that they must provide verification documents by September 5 or be terminated from coverage as of September 30.

CMS received hundreds of thousands of documents in response to the August request, reducing the number of individuals with citizenship and immigration data-matching issues from 966,000 as of May 31 to 115,000 as of September 14.  These individuals will be terminated as of September 30, 2014, but under the revised bulletin 11, they will be reinstated retroactively if they subsequently produce the documents needed to verify their citizenship or legal alien status. They may also purchase insurance outside the exchange.  Insurers are legally required to offer coverage to individuals who reside in their service area, regardless of citizenship or alien status.

Under the procedure announced on September 15, CMS is sending final notices to individuals enrolled through the federally facilitated exchange who still have income-related data-matching issues, informing them that they must send required information to verify their income as of September 30, 2014 or their premium tax credits and cost-sharing reduction payments will be modified to reflect information reflected in data sources otherwise available to CMS.  For example, if an enrollee’s 2012 tax return reported income higher than that reported by the enrollee on his or her application for advance premium tax credits and cost-sharing assistance, and the enrollee failed to provide verification of the claimed income, the enrollee’s premium tax credits and cost-sharing reduction payments would be modified as of November 1 in accordance with the income reflected in the tax return.

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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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