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North Carolina Dental Board v. FTC: A Bright Line On Whiter Teeth?


October 30th, 2014

On October 14, 2014, the United States Supreme Court heard oral arguments in North Carolina Board of Dental Examiners vs. Federal Trade Commission.  The case does not involve the Affordable Care Act, but it goes to the heart of the professional self-regulatory paradigm that has governed the U.S. health care system for more than a century.  The specific legal question under review is the standard for determining when a state professional licensing board’s activities are subject to scrutiny for anticompetitive effect under the federal antitrust laws.

Antitrust law applies to private anticompetitive conduct.  Congress did not intend to interfere with state regulation that limits or even eliminates competitions.  As long as states do so using public agencies and officials, they are on safe ground.  If a state empowers private parties to administer such regulation, however, it not only must “clearly articulate” its intent to diminish competition, but also must “actively supervise” the conduct of the private parties.  In previous cases, the Supreme Court developed and elaborated this two-part test, which is called the “state action doctrine.”

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Tax-Exempt Status For Nonprofit Hospitals Under The ACA: Where Are The Final Treasury/IRS Rules?


October 23rd, 2014

Months have now stretched into years, and there still remains no sign of final Treasury/IRS regulations interpreting the Affordable Care Act (ACA)’s provisions covering the expanded obligations of nonprofit hospitals that seek tax-exempt status under §501(c)(3) of the Internal Revenue Code.

The ACA amendments do not depend on formal agency policy to take effect. Nonetheless, Congress directed the Treasury Secretary to issue regulations and guidance necessary to carry out the reforms (26 U.S.C. §501(r)(7)). To this end, two important sets of proposed rules were issued: the first in June, 2012; and the second, in April 2013. While an informative IRS website lists various proposed rules and guidelines important to nonprofit hospitals, final rules seem to have performed a disappearing act.

Apparently recognizing the problems created by its delays, the agency has gone so far as to issue a special Notice letting nonprofit hospitals (and presumably the public) know that they can rely on its proposed rules. But this assurance overlooks the fact that the proposed rules themselves contained crucial areas in which final agency policy has not yet been adopted.

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Health Affairs Web First: Noneconomic Damage Caps Reduced Medical Malpractice Payments, With Varied Effects


October 22nd, 2014

With the 2014 election weeks away, a provision of California’s Proposition 46, raising the cap on medical malpractice payments for noneconomic damages, has been in the news. This provision would increase the payment cap from $250,000 to $1.1 million. A new study, being released today by Health Affairs as a Web First, sheds light on the potential effect of this proposition.

Study authors Seth A. Seabury, Eric Helland, and Anupam B. Jena looked at the impact of medical malpractice reforms on the average size of malpractice payments in several physician specialties and compared how the effects differed according to the size of the cap. It found that caps reduced the average payments by 15 percent compared to no cap—and a $250,000 cap reduced average payments by 20 percent.

On the other hand, a less restrictive $500,000 cap had no significant effect. The authors also found specialty variations, with the largest impact involving pediatricians and the smallest for claims of surgical subspecialties and ophthalmologists.

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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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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: Judge Rules Against Premium Tax Credits In ACA Federal Exchanges (Updated)


September 30th, 2014

On September 30, 2014, Judge Ronald White of the United States District Court for the Eastern District of Oklahoma decided in Pruitt v. Burwell and Lew that the Affordable Care Act does not authorize the federally exchanges to issue premium tax credits.  He held that the Internal Revenue Service rule that provided the contrary is invalid.  Judge White’s decision followed the opinion of the majority of a panel of the District of Columbia circuit’s decision in Halbig v. Burwell, although the judgment in that case has been vacated pending a rehearing of the case by the full D.C. Circuit.  His decision was contrary to the decision of the Fourth Circuit Court of Appeals upholding the IRS rule in King v. Burwell.  The district courts in both Halbig and King had upheld the IRS rule.

The Pruitt case has a long and circuitous history.  It was originally filed by Oklahoma attorney general Scott Pruitt in 2011 as an individual mandate challenge.  After the Supreme Court upheld the individual mandate in 2012, Attorney General Pruitt amended his complaint to instead challenge the ability of the federally facilitated exchanges to issue premium tax credits.  In an earlier ruling, Judge White refused to allow Oklahoma to sue on its own behalf as a state (a ruling that Judge White did not change in this decision), but concluded that it might have standing to proceed as a large employer.

In his September 30 ruling, Judge White concluded that Oklahoma did in fact have standing to sue as a large employer.  Under the ACA’s employer responsibility provisions, a large employer that does not offer its employees affordable and adequate coverage can be subject to a tax penalty if one or more of its employees receives premium tax credits through the exchange.  If the federally facilitated exchange, which is the ACA exchange in Oklahoma, is unable to grant premium tax credits, Oklahoma, which is a large employer, cannot be subject to a penalty if it fails to offer coverage to its employees.

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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: 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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Implementing Health Reform: Exchange Eligibility Redeterminations Final Rule


September 3rd, 2014

On September 2, 2014, as Americans returned to their labors following the Labor Day holiday, the Department of Health and Human Services (HHS) released its Annual Eligibility Redeterminations for Exchange Participation and Insurance Affordability Programs final rule, the last rule that had to be in place for the 2015 open enrollment period. HHS also released a fact sheet describing the rule and forms for insurers to use when discontinuing or renewing an insurance product.

The rule finalizes a proposed rule issued in June, which I also analyzed on Health Affairs Blog. The proposed rule was accompanied by a guidance describing how the federally facilitated marketplaces (FFMs) intended to handle the 2015 redetermination process. That guidance is unchanged by the final rule.

Indeed, virtually nothing in the proposed rule is changed by the final rule. The preface to the rule offers some additional explanation of the reenrollment and redetermination process in response to the 36 comments received on the proposed rule, but virtually no changes were made other than minor wording changes.

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Implementing Health Reform: New Accommodations For Employers On Contraceptive Coverage


August 22nd, 2014

On August 22, 2014, the Departments of Health and Human Services, Labor, and Treasury released an interim final  and a proposed  rule providing for the accommodation of religious objections on the part of an employer or institution of higher learning to providing their employees or students coverage for contraceptive services.  A fact sheet on the rules was also released,   as was a notice on the revision of the form used to collect information on religious objections to contraceptive coverage.

The proposed rule, which applies to for-profit entities, is being issued in response to the Supreme Court’s decision in Burwell v. Hobby Lobby, which ruled that closely-held for-profit corporations may refuse to cover contraceptives for religious reasons.  The interim final rule responds to the Court’s interim order in Wheaton College v. Burwell  (and to 31 lower court injunctions) that released religious non-profit organizations from accommodations earlier proposed by HHS.

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Whither CHIP?


August 19th, 2014

In a day all but lost to Affordable Care Act prehistory, on November 7, 2009, the House of Representatives passed the Affordable Health Care for America Act. Among the bill’s many differences with its Senate counterpart, it would have allowed the Children’s Health Insurance Program (CHIP) to expire at the end of 2013, with children covered under that program enrolled in either Medicaid or commercial Exchange plans.

On December 24, the Senate passed the Patient Protection and Affordable Care Act (ACA). Their bill extended CHIP through fiscal year 2015 while, curiously, enhancing the Federal match rate for the program beyond that date and instituting a maintenance of effort (MOE) requirement for states to keep CHIP kids covered through 2019.

At the time, drafters of the respective chamber’s versions of health reform anticipated heading to conference to negotiate and resolve their differences, with the disposition of CHIP one of the top considerations.

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Implementing Health Reform: ACA-Related Litigation, Special Enrollment Periods, And Navigator Certification And Training (Updated)


August 13th, 2014

Two federal district courts have issued decisions in recent days in litigation relating to the Affordable Care Act. This post will analyze those cases as well as describe two new special enrollment periods recognized by the Centers for Medicare and Medicaid Services (CMS) in guidance issued on August 4, 2014.

A decision on motion to dismiss Indiana case regarding premium tax credits in the federally facilitated exchange.  First, on August 12, 2014, Judge William T. Lawrence of the United States District Court for the Southern District of Indiana issued an opinion in Indiana v. the IRS, one of the cases challenging the legality of the Internal Revenue Service rule recognizing the issuance of premium tax credits through the federal exchanges. There are currently four cases raising this issue pending in federal courts in Oklahoma, Indiana, Virginia, and the District of Columbia.

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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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Posts On ACA Legal Challenges Lead Health Affairs Blog July Top Ten


August 7th, 2014

Two posts regarding legal challenges to the Affordable Care Act were the most-read Health Affairs Blog posts in August. In the top spot: Tim Jost’s discussion of Supreme Court actions that were arguably at odds with the Court’s Hobby Lobby decision. Next on the list: another post by Jost analyzing two federal appellate court decisions taking conflicting positions on whether consumers may receive premium tax credits under the ACA in states using the federally facilitated exchange.

Number three on the July top-ten list is Suzanne Delbanco’s post on bundled payment, part of her ongoing series on payment reform; Jennifer DeCubellis and Leon Evans’ post on investing in care coordination is next.

The full list is below:

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Health Affairs August Issue: Variations In Health Care


August 4th, 2014

Health AffairsAugust variety issue includes a number of studies demonstrating variations in health and health care, such as differing obstetrical complication rates and disparities in care for diabetes. Other subjects in the issue include the impact of ACA coverage on young adults’ out-of-pocket costs; and how price transparency may help lower health care costs.

For mothers-to-be, huge differences in delivery complication rates among hospitals.

Four million women give birth each year in the United States. While the reported incidence of maternal pregnancy-related mortality is low (14.5 per 100,000 live births), the rate of obstetric complications is nearly 13 percent.

Laurent Glance of the University of Rochester and coauthors analyzed data for 750,000 obstetrical deliveries in 2010 from the Healthcare Cost and Utilization’s Nationwide Inpatient Sample. They found that women delivering vaginally at low-performing hospitals had twice the rate of any major complications (22.55 percent) compared to vaginal deliveries at high-performing hospitals (10.42 percent

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Implementing Health Reform: King Plaintiffs Ask For Supreme Court Review


August 1st, 2014

On July 31, 2014, Michael Carvin, attorney for the plaintiffs in King v. Burwell, one of two parallel cases challenging an IRS rule allowing premium tax credits to be issued by federally facilitated exchange, filed a petition for a writ of certioriari in the United States Supreme Court. The petition asks the Court to review the Fourth Circuit decision affirming Judge James Spencer’s ruling rejecting their claim.

As was described here in detail last week, ACA opponents lost in the Fourth Circuit in a unanimous decision in King v. Burwell but won a split decision in the District of Columbia Circuit Court of Appeals in Halbig v. Burwell. Carvin is thus seeking Supreme Court review based on a split of authority between the circuits that must be resolved by the Supreme Court.

It is not the intent of this post to review the arguments in Carvin’s brief. Carvin argues that judges Griffith and Randolph made the right decision in Halbig, and that judges Gregory, Thacker and Davis in the Fourth Circuit and Edwards in the D.C. Circuit are wrong. There is really only one new argument in the petition that was not made below, namely that Congress’ intent to deny premium tax credits in states that failed to establish exchanges has now been conclusively established by statements made by Jon Gruber two years after the statute was adopted. This disregards the fact that Gruber neither drafted nor voted on the ACA and had earlier stated that premium tax credits were available in federally facilitated exchange states.

Rather than rehashing the merits, this post will discuss the timing of the petition, the basis on which it can be accepted, and the consequences if it succeeds. Nothing will happen immediately with this petition. The government has 30 days to respond, and can request additional time. The appellants then have 14 days to reply. This puts us into mid-September. It is unlikely, therefore, that the Supreme Court will decide whether or not to accept the petition until it reconvenes in October

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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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Implementing Health Reform: Origination Clause Challenge To ACA Dismissed (Updated)


July 30th, 2014

Another Affordable Care Act challenge bit the dust on July 29, 2014, when the District of Columbia Court of Appeals affirmed a lower court decision that dismissed Sissel v. Department of Health and Human Services. Sissel had sued claiming first that the individual mandate “is not a regulation of commerce, but purports to compel affected Americans like [himself], to engage in commerce,” and second that the “shared responsibility payment” is a tax and violates the Origination Clause because it “originated in the Senate, not the House.”

The court had little trouble disposing of Sissel’s first claim, which, the court explained, was based on a misreading of the Supreme Court’s opinion in the NFIB case. Although five justices of the NFIB Court concluded that Congress lacked the authority to enact the individual mandate as a command under the Commerce Clause, a majority of the Court also concluded that the mandate did not in fact order individuals to purchase insurance, but rather imposed a tax on those who failed to do so. The requirement was thus, as the Supreme Court had already held, constitutional.

Sissel’s second claim was based on article 1, section 7, clause 1 of the Constitution, the Origination Clause, an obscure provision few Americans remember from fifth grade civics. It provides that “[a]ll Bills for raising Revenue shall originate in the House of Representatives; but the Senate may propose or concur with Amendments as to other bills.” Sissel argued that the individual mandate of the ACA was a bill to raise revenue but that the ACA in fact originated in the Senate, and thus the provision was unconstitutional.

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Implementing Health Reform: What Makes A State Exchange? (Updated)


July 28th, 2014

One question that has arisen in the wake of the Halbig/King decisions is what exactly is a state exchange? The D.C. Circuit in Halbig and the Fourth Circuit in King seemed unclear as to the answer to this question. The D.C. Circuit counted 14 state exchanges, the Fourth Circuit 16.

A great deal, however, may turn on the answer. Two of the eight federal judges that have ruled on the question so far have held that only state exchanges and not federally facilitated exchanges can issue premium tax credits. Were this conclusion to be adopted in the end by the Supreme Court, which exchanges would count? In other words, how exactly does a state establish an exchange?

A careful reading of the law suggests that a state “establishes” an exchange when, exercising the legal powers of the executive or legislative branch, the state government takes certain actions, discussed below. Establishing the exchange – that is, using the power of state government to enable the exchange to operate and fulfill its responsibilities – is different from the carrying out the day-to-day operations, of the exchange, which might be carried out by public officials, private contractors, or even the federal government.

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