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New Health Policy Brief: Risk Corridors (Updated)


February 26th, 2015

The latest Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) provides an update to an earlier brief on the Affordable Care Act (ACA)’s risk corridor program, which allows the Department of Health and Human Services (HHS) to collect and make payments to qualified health plans. As the brief explains, a recent amendment to federal appropriations raises questions as to whether insurers will receive their full risk corridor payments for 2014.

While the Consolidated and Further Continuing Appropriations Act of 2015, which funded the government for the 2015 fiscal year, did give HHS the authority to collect user fees, an amendment was included that specifically prohibited HHS from transferring money from either trust fund.

The amendment did not eliminate the risk corridor program, nor did it prevent HHS from using payments received from insurers to pay out claims under the program (that is, user fees), but it effectively made the risk corridor program budget neutral unless HHS can find another source of funding. As a result, insurers expecting payments from HHS may not receive the full amount due.

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State Expectations: Setting The Record Straight In King v. Burwell


February 25th, 2015

On Wednesday, March 4th, the Supreme Court will hear the latest attack on the Affordable Care Act (ACA): the case King v. Burwell. The King petitioners allege that the Internal Revenue Service overstepped its authority by issuing regulations authorizing residents of states with federally run exchanges to access premium tax credits. The petitioners claim that Congress intentionally limited access to premium tax credits to residents of state-based exchanges as a way to encourage states to run their own exchanges.

In support, some state officials claim that they interpreted the law in this manner and that it impacted their state’s decision not to operate a state-run exchange. These assertions, like their analysis of the statutory language, fall flat under any serious scrutiny, however.

Between October 2012 and March 2013, with the support of the Commonwealth Fund, the Center on Health Insurance Reforms (CHIR) conducted a comprehensive review of publicly available information in 50 states pertaining to their decisions to operate either a state or federally run exchange.

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Implementing Health Reform: Beginning The Cadillac Tax Regulatory Conversation And Other ACA News (Updated)


February 24th, 2015

The Cadillac high-cost health plan excise tax, which goes into effect in 2018, is one of the last-to-be-implemented provisions of the Affordable Care Act (ACA). It was one of the most controversial provisions of the ACA, which contributed to its delayed effective date. But 2018 is now getting closer, and the Internal Revenue Services (IRS) is beginning a discussion about implementation of the Cadillac plan tax.

The Cadillac plan provision of the ACA will impose a 40 percent excise tax on the cost of employer-sponsored health plans when that cost exceeds certain thresholds. It is projected to be one of the biggest sources of revenue under the ACA; the Congressional Budget Office (CBO) in its 2015 Budget and Economic Outlook Report estimated that it would account for $149 billion in revenue between 2018 and 2225. Of this, however, only one quarter will come from the tax itself, while three quarters will come from increases in taxes on income as employers shift compensation from health benefits to taxable wages.

While the tax will affect few plans initially, it is likely to affect many more plans over time as the cost of health care continues to grow faster than inflation generally. The tax is expected to reduce health care expenditures by individuals, as it will drive employers to increase employee cost sharing as they cut the cost of coverage, and employees are likely to spend less on health care if they have to purchase it out-of-pocket rather than drawing on insurance coverage.

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Putting Humpty Dumpty Together Again: Consolidating Regulatory Authority Over Food Safety


February 23rd, 2015

The fragmented nature of regulatory authority over food in the United States is well known. More than a dozen federal agencies are responsible for the safety of the nation’s food supply. The Food and Drug Administration (FDA) and the Department of Agriculture (USDA) have the lion’s share of responsibility, together overseeing over 80 percent of the nation’s food safety.

Generally, the USDA regulates meat, and the FDA regulates everything else, but overlaps, exceptions, gaps, and therefore examples of resulting absurdities abound: the FDA regulates frozen pizza, unless it has pepperoni. The FDA regulates seafood, unless it’s catfish. The USDA has jurisdiction over packaged open-face meat sandwiches, but if the sandwiches are closed, authority shifts to the FDA.

This division in regulatory authority is neither planned nor rational. It is instead a historical accident, originating in the early twentieth century. When the Pure Food and Drug Act and Meat Inspection Act were passed on the same day in 1906, both targeting the adulteration of the food supply, their oversight was assigned to different departments within the USDA. The fissure widened when the FDA was moved out of the USDA in 1940. This divided regulatory framework is not the only reason for the fragmentation of regulatory authority over food in the US, but it is a main driver.

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In Regulating E-Cigarettes, No Easy Fix For The FDA


February 20th, 2015

Sometime in the next few months, the Food and Drug Administration (FDA) is expected to issue the so-called deeming regulations, which will open the door to the federal regulation of e-cigarettes. In considering whether to issue the regulations, which were first published for notice and comment rulemaking last April, the FDA faces a formidable challenge: it must decide whether and how to regulate in the midst of scientific uncertainty and limited statutory flexibility.

By subjecting e-cigarettes to its regulatory regime, the FDA risks retarding the growth of what may prove to be a powerful new tool for harm reduction. But by failing to act, the agency risks undermining decades of progress in tobacco control. In either case, the public health impact is apt to be significant.

It is a victory that was made possible, in large measure, by a constellation of state and federal regulatory interventions: laws regulating the marketing and sale of cigarettes, barring sales to youth, banning indoor smoking, and taxing cigarette sales have all played a role in reducing rates of smoking.

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The Latest Health Wonk Review


February 19th, 2015

Last week Peggy Salvatore posted a Valentine’s Day edition of the Health Wonk Review at the Health System Ed blog. Peggy includes Ron Pollack’s Health Affairs Blog “Contributing Voices” post arguing that both the text of the Affordable Care Act and congressional intent indicate that premium tax credits should be available in states using the Federally Facilitated Marketplace.

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Implementing Health Reform: Enrollment Figures, Tax Forms, And More


February 13th, 2015

We are rapidly reaching the end of the 2015 open enrollment period, and the pace of enrollment seems to be picking up a bit. On February 11, 2015, the Centers for Medicare and Medicaid Services (CMS) released their enrollment snapshot for week twelve, covering the federally facilitated marketplace from January 31 to February 6.

During that time period, 275,676 individuals selected plans, bringing of enrollees in the federal exchange up to 7,749,375. The Department of Health and Human Services (HHS) reportedly announced on a press call on February 11, however, that 200,000 individuals will be dropped from enrollment in February for failure to satisfactorily document compliance with citizenship or residency requirements.

Enrollment is expected to continue to pick up during the final ten days of open enrollment, as it did last year. CMS has said that if an individual cannot get through at the call center or online on February 15, CMS will make sure that he or she can apply for coverage, but the agency has not announced any further relief nor any new special enrollment periods for 2015. I continue to urge CMS to provide a special enrollment period for people who were subject to the individual responsibility penalty for 2014 to allow them to avoid the penalty for 2015.

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King v. Burwell: Congressional Intent And The Statutory Language Are Aligned


February 5th, 2015

On March 4, 2015, the Supreme Court will hear oral arguments in King v. Burwell. That suit was filed by opponents of the Affordable Care Act (ACA) to stop tax-credit premium subsidies from being provided to moderate-income people in 34 states where the federal government is running health insurance exchanges in lieu of the states. According to the Urban Institute, it could result in the withdrawal of such subsidies for 9.3 million moderate-income people by 2016, and, according to the Rand Corporation, enrollment in coverage could drop by 9.6 million.

Some believe the King lawsuit is a contest between, on the one hand, congressional intent that premium subsidies should be provided in all states, versus, on the other hand, statutory language that says the opposite. Those who believe this formulation are half right: they are correct that Congress clearly intended subsidies to be provided to moderate-income families irrespective of whether their state of residence chose to run its marketplace directly instead of leaving it to the federal government; however, they are mistaken about the ACA’s language, which equally clearly indicates that subsidies should be provided in all states.

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Is Bias A Source Of Unmet Needs For Medically Complex Kids?


February 2nd, 2015

A study on the “Inequities In Health Care Needs For Children With Medical Complexity,” published in the December 2014 issue of Health Affairs on children’s health, supports a suspicion I have had for some time. Children with medical complexity face the possibility of unmet health care needs simply because of who they are.

Dennis Kuo and colleagues found that children with medical complexity had higher unmet needs than children without medical complexity. The authors describe medical complexity as “children who require medical services beyond what is typically required by children with special health care needs.”

This inequity holds regardless of race, ethnicity, insurance coverage, and household income in relation to poverty level. In other words, unmet needs remain high even among those who have favorable social determinants of health care. The authors conclude that medical complexity itself may be an independent determinant of health care inequity for children.

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Implementing Health Reform: ACA-Related Tax Penalties Waived; High Court Turns Back Oklahoma AG (Open Enrollment, CO-OP UpDate)


January 27th, 2015

The Internal Revenue Serviceissued a Notice on January 26, 2015 stating that it intends to grant relief from certain penalties that could otherwise be imposed on individuals who have a balance due on their 2014 taxes because the amount that they received in advance premium tax credits exceeded the amount that they were actually due.  The penalties are those that would otherwise apply for late payment of a balance due and for underpayment of estimated taxes.  The relief only applies to individuals who meet certain requirements and only for 2014.

Section 6651(a)(2) of the Internal Revenue Code imposes a penalty for a failure to pay the amount of taxes owing on a tax return by the date it is due, which is usually April 15 of the following year.  It does not apply if the failure was due to a reasonable cause.  Section 6654(a) imposes a penalty for underpayment of estimated taxes, although it does not apply unless the underpayment exceeds certain limits and can be waived under certain circumstances.

Individuals who received advance premium tax credits during 2014 must reconcile these amounts with the premium tax credits they were actually owed.  In some instances this will result in an overpayment, which must be repaid to the IRS.  Absent the relief granted by this Notice, some of enrollees who received too much in premium tax credits might owe a penalty for failing to repay the overpayment by April 15 or for failing to have paid enough in estimated taxes to cover the amount due.

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Competition In Health Care Markets


January 26th, 2015

In this post, I want to focus on the key role economic analysis plays in the Federal Trade Commission (FTC)’s health care enforcement program. I use this lens to look first at how the FTC has become more successful in challenging hospital mergers, and then to rebut the notion that the Affordable Care Act is somehow a “free pass” for health care industry consolidation.

After the federal antitrust agencies successfully challenged a number of hospital mergers in the 1980s and early 1990s,[1] we suffered a string of court losses in the mid- and late-1990s, even in cases involving highly concentrated hospital markets.[2] In 2002, the FTC decided to take a step back and examine the reasons for our losses, and whether our analysis of hospital markets was correct.

We engaged in an in-depth retrospective study, used our authority to collect data from hospitals and insurance companies, and held workshops along with DOJ. (See here, here, here, and here.) Cory Capps of Bates and White, and other economists contributed significantly to our understanding as well. This intense period of reflection led to several important papers demonstrating that the consummated mergers stemming from the hospital merger challenges we lost—including those involving non-profits—resulted in anticompetitive effects, particularly increased prices. We also determined that our losses were due in part to the courts’ acceptance of faulty economic analysis of geographic and competitive effects. (See here, here, and here.)

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Beyond Law Enforcement: The FTC’s Role In Promoting Health Care Competition And Innovation


January 26th, 2015

By now, the Federal Trade Commission’s (FTC) law enforcement efforts in the health care area are well known. We have successfully challenged several hospital and physician practice mergers in the last few years. We also continue to pursue anticompetitive pharmaceutical patent settlements, following a victory at the Supreme Court in the Actavis case. Speaking of the Court, it is currently reviewing a case we brought against the North Carolina Board of Dental Examiners, alleging that its members conspired to exclude non-dentists from providing teeth whitening services in North Carolina.

Perhaps less publicized are the FTC’s various non-enforcement efforts in health care. Arguably most significant among those is the advocacy that the agency conducts in favor of competition principles before state legislatures and other policymakers. I will discuss our advocacy efforts in the health care space in this post, and then turn to the subject of telemedicine, an area in which FTC competition policy may play a significant role.

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Last Year Was A Wild One For Health Law — What’s On The Docket For 2015?


January 22nd, 2015

Everywhere we look, we see the tremendous impact of new legal developments—whether regulatory or statutory, federal or state—on health and health care. These topics range from insurance to intellectual property to religion to professionalism to civil rights. They remain among the most important questions facing Americans today.

This post is the first in a series that will stem from the Third Annual Health Law Year in P/Review event to be held at Harvard Law School on Friday, January 30, 2015. The conference, which is free and open to the public, brings together leading experts to review major developments in health law over the previous year, and preview what is to come.

The event is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine, and co-sponsored by Health Affairs, The Hastings Center, and the Center for Bioethics at Harvard Medical School. Below, we will highlight a few themes that have emerged so far. The conference’s speakers will author a series of posts that follow on more specific topics.

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Sovaldi, Harvoni Payment Issues Lead Health Affairs Blog November Most-Read List


December 24th, 2014

A piece by Laura Fegraus and Murray Ross on the challenges of paying for lifesaving but high-priced drugs like Sovaldi and Harvoni from was the most-read Health Affairs Blog post for November. This was followed by a critical analysis of workplace wellness programs from Al Lewis, Vik Khanna, and Shana Montrose.

Next came a post on the 2016 Notice of Benefit and Payment Parameters Proposed Rule from Tim Jost, and then a look at health care policy after the mid-term elections from James Capretta.

The full top-ten list for November is below.

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New Health Policy Brief: Reenrollment


December 22nd, 2014

This year open enrollment under the Affordable Care Act (ACA) began on November 15, allowing new customers to sign up for health insurance. Open enrollment also provided current policyholders the chance to change plans and request a redetermination on the amount of subsidy they received. During this second year of open enrollment for the ACA’s insurance Marketplaces, insurers and policy makers are working to keep last year’s enrollees in the system — and the Department of Health and Human Services (HHS) estimates that 95 percent of them are eligible for automatic renewal.

A new policy brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) examines the pros and cons of reenrollment options for consumers, whether they are using the federal Marketplace or live in states that operate their own exchanges. Automatic reenrollment means that almost seven million people already enrolled will not necessarily need to flood HealthCare.gov and exchanges during open enrollment. On the other hand, it also may discourage consumers from exploring alternative coverage that might better fit their needs and get a more accurate determination of eligibility for subsidies.

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Health Affairs Web First: The Bottom Line On Different Management Models In State Health Exchanges


December 17th, 2014

The Affordable Care Act gives states discretion as to how they design their health insurance Marketplaces. Some states run their own Marketplace; others are part of the federally facilitated exchange; and a few chose a state-federal partnership. All states have plan management responsibilities, and if a state runs its own Marketplace, it has management choices. A “clearinghouse” model of management is when all health plans meeting published criteria are accepted into the exchange.

This model is used by some state-run exchanges and all the state-federal partnerships and federally facilitated exchanges. The alternative is the “active purchasing” model, allowing a state to directly negotiate premiums, provider networks, and other details. This model has been adopted by ten of the seventeen state-run exchanges.

A new study, released today as a Web First by Health Affairs, found that in the 2013–14 open enrollment period, state-based Marketplaces using a clearinghouse model had significantly lower adjusted average premiums for all plans within each metal tier (bronze, silver, and gold) compared to state-based Marketplaces having active purchasing models. This study offers the first attempt to assess the premium differences across Marketplace models.

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Implementing Health Reform: Beneath The Hood Of The ‘Cromnibus’


December 12th, 2014

The “Consolidated and Further Continuing Appropriations Act, 2015” or “Cromnibus” legislation moving through Congress contains a number of provisions that relate to the implementation of the Affordable Care Act (ACA).

Risk Corridors

The provision that has been most widely noted so far requires the risk corridor program to be budget neutral for 2014. The risk corridor program moves funds from qualified health plans (QHPs) that have lower than anticipated allowable costs to those with higher than anticipated allowable costs. Section 1342 of the ACA, which creates the risk corridor program, contains no explicit appropriation.

A report issued earlier this year by the Government Accountability Office (GAO), which is the final authority on the legitimacy of government expenditures, determined that the continuing resolution for 2014 permitted the Centers for Medicare and Medicaid Services (CMS) to fund the risk corridor program for 2014 both from payments collected from plans with lower than anticipated costs, which were properly characterized as user fees, and from funds transferred from other CMS accounts. No risk corridor payments were in fact payable in 2014, however, as risk corridor payments will first be made in 2015 for 2014.

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The Accidental Administrative Law Of Policymaking In The Medicare Program


December 11th, 2014

Editor’s note: This post is part of a series of several posts stemming from presentations given at “The Law of Medicare and Medicaid at Fifty,” a conference held at Yale Law School on November 6 and 7.

When Congress establishes a new regulatory program, it lodges the program in a regulatory agency or executive department. A regulatory agency generally has presidentially appointed commissioners with staggered terms and expert staff. This design provides insulation from politics and facilitates applying technical expertise to regulatory problems. Also, administrative agencies make rules and policy and have the powers of investigation, adjudication, and sanction to enforce compliance. Administrative law, an essential instrument of democracy, regulates the operation and procedures of government agencies.

The Social Security Amendments of 1965 established Medicare in the Social Security Administration (SSA). Medicare initially contained two parts, hospital insurance for hospital and related services and supplementary medical insurance for physician and other outpatient services. Pursuant to contract, Medicare contractors handle claims and pay providers as well as adjudicate appeals and make program policy.

This post chronicles the development administrative law, policymaking, and regulation in the Medicare program. It describes how the program evolved a revolutionary collaborative model of regulation that could provide a useful guide for other programs.

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Two Theologies Have Blocked Medicare-For-All


December 11th, 2014

Editor’s note: This post is part of a series of several posts stemming from presentations given at “The Law of Medicare and Medicaid at Fifty,” a conference held at Yale Law School on November 6 and 7.

In the 50 years since Medicare was enacted, Congress has never seriously considered extending Medicare to all Americans, nor even lowering Medicare’s eligibility age below 65. This pattern persisted even during those periods when national health insurance was at the top of the national agenda. This is not what the original advocates of Medicare anticipated when Medicare was enacted in 1965. They saw Medicare as the cornerstone of a national system of health insurance that would eventually cover all Americans.

Two Myths that Undercut Medicare-for-All: Managed Care and Competition

In the paper we presented at the Yale conference, we reviewed short- and long-term factors affecting the debate about Medicare over its lifetime, and then turned to a discussion of two long-term factors: the rise of what came to be called the managed care movement, and the resurgence of a longstanding campaign promoting the idea that competition can right the wrongs of American medicine.

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What To Watch For During This Year’s Open Enrollment Period: Lessons From The Health Reform Monitoring Survey


December 10th, 2014

The Obama Administration recently lowered its expectations on the number of individuals that are likely to enroll in health insurance plans through the Marketplace by the end of 2015—suggesting that it might be more difficult than expected to find and enroll remaining uninsured residents while retaining people who signed up during the first open enrollment period (New York Times; Wall Street Journal; Washington Post’s “Wonkblog”).

One potential barrier to enrollment is low levels of Marketplace awareness among the uninsured: September 2014 estimates from the Urban Institute’s Health Reform Monitoring Survey (HRMS) indicate that only 52 percent of uninsured adults reported hearing some or a lot about the health insurance Marketplace created by the Affordable Care Act (ACA). Despite this large knowledge gap, awareness of the Marketplace has improved since last September, when only 30 percent of the uninsured reported hearing some or a lot about the Marketplace prior to the first open enrollment period.

While increasing awareness of the Marketplace will continue to be important as the second open enrollment period unfolds, there are two additional issues that may determine how many more uninsured people actually gain coverage this year. First, will the remaining uninsured be reluctant to seek coverage and enroll during the current open enrollment period, and if so, why? Second, for people seeking information on health plans, what sources of information are they likely to turn to, and will those sources be adequate to meet the demand?

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