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Ensuring Timely Approval Of Generic Drugs


March 24th, 2015

Having saved US consumers over $1.5 trillion in the past decade, generic drugs are one of the most cost-effective interventions in our entire health care system. Using generic drugs instead of brand-name drugs, when a generic is available, has been shown to increase medication adherence and improve health outcomes for chronic conditions.

Importantly, generic drugs offer these advantages without sacrificing quality; the Food and Drug Administration’s bioequivalency standards are met and often exceeded by generic-name manufacturers, and no randomized controlled trials—the gold standard of medical evidence—have identified clinically significant variations in outcomes between brand-name and FDA-approved interchangeable generic drugs.

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Price Transparency: Removing The Blindfold


March 11th, 2015

Shopping for health care is like shopping blindfolded in Macy’s, says noted health care economist Uwe Reinhardt — consumers don’t know what they are buying or how much it will cost until they have paid and gone home. Moreover, consumers are not the only ones affected by the lack of information; employers as purchasers of insurance, government policy makers, and insurers are all frustrated by the lack of price and quality information that would allow consumers to shop for value in their care.

We hope that 2015 will be the year of transparency and the first year in an era of higher value health care. This blog post discusses our observations from the Health Care Cost Institute’s (HCCI) perspective of developing guroo.com, a transparency website: the impetus for transparency, the magnitude of the data needed, the challenges in summarizing and presenting the data, and finally realistic expectations for transparency tools.

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Go Slow On Reference Pricing: Why The Federal Agencies Have It Wrong On Regulations


March 9th, 2015

Despite concerns outlined in our previous post on reference pricing, federal oversight agencies essentially have taken a hands-off approach. First, they announced that for large group and self-insured plans, the Affordable Care Act’s (ACA) annual maximum limits on out-of-pocket costs do not apply to charges above the reference price.

These limits are already high: $6,600 for an individual and $13,200 for family coverage in 2015. Without any discussion the agencies asserted that non-designated providers are out-of-network, and therefore cost sharing falls within the ACA’s exclusion of out-of-network cost from the maximum limits.

This ruling is inconsistent with the ACA and harmful to patients, effectively allowing plans to circumvent the Act’s crucial out-of-pocket cost limits. The ACA’s annual out-of-pocket maximums are meant to apply to in-network care. If plan members receive care inside this provider network, the Act mandates that they are to be protected by these maximums.

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Go Slow On Reference Pricing: Not Ready For Prime Time


March 9th, 2015

Editor’s note: This post is part one of two on reference pricing. 

The use of reference pricing by health insurers and employee health benefit plans stands high on the policy and regulatory agenda because it is gaining popularity, particularly now that federal agencies have blessed its use by large group insurers and self-insured plans, while imposing only relatively lax requirements. The purpose of reference pricing is to enable patients to “shop” for care and to spur provider competition by creating a group of “designated” in-network providers that agree to abide by the reference price while others do not (“non-designated providers”).

Patients who select more expensive non-designated providers must pay extra, letting them decide whether the extra out-of-pocket cost is worth it. Providers compete, either by agreeing to the reference price or by lowering their prices to approach it. Prices are driven downward.

Reference pricing is superficially appealing because it invokes powers that consumers exercise every day, as they weigh cost and value for items ranging from cold cereal to new cars. But it also raises significant issues regarding quality and access to care and has the potential to discriminate against sick and vulnerable patients. The strategy may also prove costly in relation to the benefits it confers. We urge a go-slow approach and more careful regulation.

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From The Supreme Court: A Strong Endorsement Of Health Care Competition


March 2nd, 2015

The Supreme Court has spoken by a 6-3 vote, with Justice Anthony Kennedy writing an opinion for the Court joined by Chief Justice Roberts and Justices Breyer, Ginsburg, Sotomayor, and Kagan.  In a strong, clear voice, the Court upheld the enforcement of a major federal statute against a state entity that had failed to embrace federal policy with respect to health care.  Although not formally a constitutional decision, the Court’s interpretation of congressional intent played out against the backdrop of an important constitutional question: the permissible and appropriate balance between federal lawmaking and residual state authority.  And it was the federal government’s seeming disregard of state sovereignty that led what has become the Court’s conservative rump – here Justice Alito, joined by Justices Scalia and Thomas – to write bluntly in dissent.

The case is North Carolina State Board of Dental Examiners v. Federal Trade Commission, not King v. Burwell, and the major federal statute is the Sherman Antitrust Act, not the Affordable Care Act.  Oral argument in North Carolina State Board took place last October (David Hyman and I wrote about it here); the Court’s decision was issued on February 25, 2015.

North Carolina State Board has nothing to do with “Obamacare,” but it may turn out to be the most important health care (and general public law) decision of the year.  (Note to Pundits and Hypesters: King v. Burwell will only matter if the Court rules for the plaintiffs, and is unlikely to create enduring law even then. If the government wins, the case will soon be forgotten.)  The Supreme Court’s ruling will give professional licensing boards throughout the country significant pause before adopting ad hoc policies that disadvantage competing professionals or non-professionals, and it should lead to a constructive conversation (and perhaps uniform or model legislation) regarding the accountability of self-regulatory bodies to actual state government.  Its impact could be comparable to a major revamping of Joint Commission standards for health care facilities – low in visibility but dramatic in operational change.

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How To Restore The Innovation Ecosystem For Medical Technology


February 10th, 2015

The recent February issue of Health Affairswhich features a series of articles on innovation, provides us with an opportunity to examine the state of America’s innovation ecosystem for medical technology. This ecosystem has produced a myriad of medical advances, ranging from advanced imaging to molecular diagnostics, minimally invasive surgical tools, and incredibly sophisticated implants. These technologies have shortened hospital stays, reduced the economic burden of disease, and saved and improved millions of lives.

But the system is severely stressed. Policy improvements are essential if America is to remain a world leader in medical devices and diagnostics and fulfill its potential for medical progress in this century of the life sciences. In the following blog post, we will look at the current state of the medical technology industry and make some policy recommendations covering regulatory approval processes, payment and coverage policies, and tax policy.

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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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CMS Spending Report Leads Health Affairs 2014 Top-Ten List


January 13th, 2015

A report on 2012 health spending by analysts at the Centers for Medicare and Medicaid Services Office of the Actuary was the most-read Health Affairs article in 2014. To celebrate the New Year, Health Affairs is making this piece and all the articles on the journal’s 2014 top-ten list freely available to all readers for two weeks.

Health Affairs publishes annual retrospective analyses of National Health Expenditures by the CMS analysts, as well as their health spending projections for the coming decade. In the latest installment in this series — which also made our 2014 top ten — the analysts reported on 2013 health spending and discussed their findings at a Washington DC briefing. The two reports documented continued slow growth in health spending; the 2013 report featured the slowest rate of health spending growth since CMS began tracking NHE in 1960.

Next on the 2014 Health Affairs most-read list was an article on PepsiCo’s workplace wellnesss program. John Caloyeras and coauthors at RAND and PepsiCo found that the diseases management component of the program saved money, but the lifestyle management component did not. This was followed by two Narrative Matters essays by Charlotte Yeh and Diane Meier; another Narrative Matters piece, by Janice Lynn Schuster, rounded out the list at number ten.

The full top-ten list is below. And check out the 2014 most-read Health Affairs Blog posts and GrantWatch Blog posts.

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The Dane Difference: Why Are Dane County’s Exchange Premiums Lower?


December 18th, 2014

During the next few years, states and the federal government will likely seek solutions to control costs and improve quality in the Affordable Care Act (ACA) health insurance marketplaces. State and federal policymakers should look carefully at the decades-long success of the Wisconsin State Employee Health Plan (WSEHP) in controlling the rapid rise of health insurance costs in Dane County—where Madison, Wisconsin’s state capital, and the University of Wisconsin, are located—as they seek to improve the effectiveness of the ACA’s marketplaces and health insurance costs in general.

The WSEHP consistently obtains substantially lower health insurance premiums in Dane County than in Wisconsin’s 71 other counties. In 2013, an individual plan in the WSEHP was about $1,400 cheaper annually in Dane County, or 16 percent less than the average in the rest of the state; and a family plan was about $3,500 cheaper, also a 16 percent difference. This Dane difference has existed for at least a decade, with the gap slowly widening over that time.

Why does WSEHP get much lower premiums in Dane County than in the state’s 71 other counties, and what lessons can policymakers learn from this difference?

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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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Implementing Health Reform: Federal Exchange Reenrollment And More (Updated)


December 2nd, 2014

On December 1, 2014, the Centers for Medicare and Medicaid Services (CMS) released a Guidance for Issuers on 2015 Reenrollment in the Federally facilitated Marketplace (FFM).  This guidance sets out in great detail—with clarifying examples—the process which the FFM and insurers will use to send and receive enrollments and reenrollments for 2015, including the process that the FFM will use to communicate to an insurer when a 2014 enrollee selects a different insurer for 2015 coverage.  The guidance is primarily directed at insurers but should also be of interest to consumers and those who are assisting them.  It demonstrates, I believe, a much higher degree of planning and intentionality than was evident in the 2014 open enrollment period, when enrollment rules often seemed to be developed on the fly.

This post describes the reenrollment guidance, as well as initial enrollment figures for the FFM and other ACA-related developments.

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The Latest Health Wonk Review


November 21st, 2014

In this week’s “turkey edition” of the Health Wonk Review, David Harlow of HealthBlawg provides a veritable smorgasbord of health policy posts, including a Health Affairs Blog essay by Jordan Paradise on biosimilars and patent disclosures.

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An Emerging Consensus: Medicare Advantage Is Working And Can Deliver Meaningful Reform


November 6th, 2014

Since enactment of the Affordable Care Act (ACA) in 2010, much of the attention in the policy community has been on modernizing Medicare’s traditional fee-for-service (FFS) program.  Through Accountable Care Organizations (ACOs), larger “bundles” of payments to fee-for-service providers for episodes of care, and tests of pay-for-performance models, the hope is that the traditional Medicare model can be remade through sheer force of bureaucratic will.  The stated intent is to find a way to pay for value, not volume.

These efforts may or may not bear much fruit, but, over the longer term, it’s not likely to matter much.  That’s because a more important transformation of Medicare is already well underway and is occurring despite more resistance than assistance from the program’s bureaucracy.  According to the 2014 Medicare Trustees’ report, enrollment in Medicare Advantage – the private plan option in Medicare — has been surging for a decade.  In 2005 there were 5.8 million Medicare beneficiaries enrolled in MA plans — 13.6 percent of total enrollment in the program.  Today, there are 16.2 million beneficiaries in MA plans, or 30 percent of program enrollment. (See Table IV.C1)  In addition, the Medicare drug benefit, which constitutes about 12 percent of total program spending, is delivered entirely through private plans. (See Table II.B1)

As MA enrollment has surged, so has recognition of its improved value.  A recent, comprehensive review of the evidence conducted by Joseph Newhouse and Thomas McGuire of Harvard University makes a compelling case that MA plans are providing higher value services at less societal cost than the traditional FFS program.  Based on their findings, Newhouse and McGuire argue for policies that would provide incentives for even more beneficiaries to enroll in MA plans in the future.

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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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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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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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Behind The Numbers: Slight Rise In Health Care Spending Growth Projected


June 24th, 2014

PwC’s Health Research Institute (HRI) released its ninth annual Medical Cost Trend: Behind the Numbers report today. This forward-looking report is based on interviews with industry executives, health policy experts, and health plan actuaries whose companies cover a combined 93 million members. Findings from PwC’s Health and Well-being Touchstone Survey of 1,200 employers from 35 industries are also included.

HRI projects that after a five-year contraction in spending growth in the employer-sponsored market, the growth rate will rise to 6.8 percent in 2015, up from the 6.5 percent projected last year.

What are the biggest drivers of the growth in health care costs? We identify four cost inflators in this report, and I would like to highlight two. First, the economy. More than five years after the end of the Great Recession, the improved economy is finally translating into greater medical spending. Consumers are now addressing health issues they ignored or postponed previously.

Secondly, the high cost of specialty drugs. While only four percent of patients use specialty drugs, those medications account for 25 percent of total U.S. drug spending. And estimates are that U.S. specialty drug spending will quadruple by 2020

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Implementing Health Reform: Premiums And Choice In The 2014 Health Insurance Marketplace (Updated)


June 18th, 2014

In the fall of 2013 the headlines were full of stories of individuals facing steep premium increases as the Affordable Care Act’s market reforms went into effect. The question was raised repeatedly whether Affordable Care Act premiums were really affordable. Commentators observed that major national commercial insurers were avoiding the exchanges and that in some states the ACA marketplace offered few choices and little competition.

On June 17, 2014, the Health and Human Services Assistant Secretary for Planning and Evaluation (ASPE) released a report surveying Premium Affordability, Competition, and Choice in the Health Insurance Marketplace, 2014. ASPE examined over 19,000 2014 marketplace plans within the four bronze, silver, gold, and platinum metal levels in each of the 501 geographic rating areas in the 50 states and the District of Columbia; the office analyzed premium levels, available choices, and market variables that might affect cost. It is always possible to find negative anecdotes (particularly if one is not too careful in checking their veracity), but when we look beyond anecdotes at the actual data, it is clear that the ACA was largely successful in achieving many of its goals for 2014.

One of the primary goals of the ACA is to make health insurance affordable to lower-income Americans. During the 2014 open enrollment period, 5.4 million individuals selected a plan in the 36 states served by the federal exchange (which are the states primarily covered by the report since state exchange data is still being assembled and analyzed). According to the report, 87 percent of these individuals qualified for a premium tax credit. They paid a premium that was, on average, 76 percent less than the full premium that they would have owed before the premium tax credit was applied.

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How Much Market Power Do Hospital Systems Have?


June 12th, 2014

Sometimes big game hunters find frustration when their prey moves by the time they’ve lined up to blast it. That certainly appears to be the case with the health policy target de jour: whether providers, hospital systems in particular, exert too much market power. A recent cluster of papers in Health Affairs and policy conferences this spring have targeted the question of whether hospital mergers have contributed to inflation in health costs, and what to do about them.

Hospitals’ market power appears to be one of those frustrating moving targets. The past eighteen months have seen a spate of hospital industry layoffs by market-leading institutions, and also a string of terrible earnings releases from some of the most powerful hospital systems and “integrated delivery networks” in the country. These mediocre operating results raise questions about how much market power big hospital systems and IDNs do, in fact, exert.

The two systems everyone points to as poster children for excessive market power-California-based Sutter Health and Boston’s Partners Healthcare, both released abysmal operating results in April. Mighty Partners reported a paltry $3 million in operating income on $2.7 billion in revenues in their second (winter) quarter of FY14. Partners cited a 4.5 percent reduction in admissions and a 1.6 percent decline in outpatient visits as main drivers. Captive health insurance losses dragged down Partners’ patient care results.

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