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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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Same Care No Matter Where She Gives Birth: Addressing Variation In Obstetric Care Through Standardization


September 12th, 2014

In August, Health Affairs published a study highlighting an alarming fact in maternal health: The incidence of childbirth complications varies significantly from hospital to hospital across the United States. The study – led by Laurent Glance and colleagues at the University of Rochester – found that “women delivering vaginally at a low-performing hospital had twice the rate of any major complications than women delivering vaginally at a high-performing hospital.” The difference in these complication rates for cesareans was five-fold.

It is well known that variation in care contributes to higher rates of mortality and morbidity in all areas of health care, explaining the push toward checklists and other quality improvement tools and interdisciplinary collaboration. Identifying the primary reasons for variation in obstetric complication rates – why women giving birth in high-performing hospitals have lower complications rates – could be critical to understanding the reasons behind the increasing rates of maternal mortality and morbidity in the U.S. This study, along with other disturbing statistics, underscores the significant need for improvements in maternity care.

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Birth Control Pills Should Be Available Over The Counter, But That’s No Substitute For Contraceptive Coverage


September 10th, 2014

In recent weeks, some opponents of the Affordable Care Act’s (ACA) contraceptive coverage guarantee have promoted the idea that oral contraceptive pills should be available to adult women without a prescription. Sens. Kelly Ayotte (R-NH) and Mitch McConnell (R-KY), for example, recently introduced the so-called Preserving Religious Freedom and a Woman’s Access to Contraception Act, a bill that would urge the Food and Drug Administration (FDA) to study whether to make contraceptives over the counter (OTC) — though for adults only.

Making birth control pills available over the counter, if done right, would meaningfully improve access for some groups of women. However, such a change is no substitute for public and private insurance coverage of contraceptives — let alone justification for rolling back coverage of all contraceptive methods and related services for the millions of women who currently have it.

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Improving Access To High Quality Hospice Care: What Is The Optimal Path?


September 9th, 2014

Editor’s note: This post is part of a periodic Health Affairs Blog series on palliative care, health policy, and health reform. The series features essays adapted from and drawing on an upcoming volume, Meeting the Needs of Older Adults with Serious Illness: Challenges and Opportunities in the Age of Health Care Reform, in which clinicians, researchers and policy leaders address 16 key areas where real-world policy options to improve access to quality palliative care could have a substantial role in improving value.

High quality hospice care is consistent with the country’s stated health care reform goals: hospice is person-centered, improves clinical outcomes such as pain and satisfaction, is provided by a multidisciplinary care team, is coordinated across care settings, reduces unnecessary hospitalizations, and saves health care dollars. Studies have consistently shown that hospice improves quality for patients and families by reducing symptom distress, improving caregiver outcomes, and reducing hospitalizations near the end of life, including emergency department visits and intensive care unit stays and hospital death.

But what about access? Fortunately, hospice care in the United States is growing rapidly and there is much to celebrate in terms of the increase in the number of hospice agencies, the number of patients and families served by hospice, and the breadth of conditions and diagnoses of patients receiving hospice care. In 2011 there were more than 3,500 hospice providers — an increase of 53 percent from 2000 — caring for 1.2 million Medicare beneficiaries.

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Transcending Obamacare? Analyzing Avik Roy’s ACA Replacement Plan


September 2nd, 2014

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

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

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

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Rescue Me: The Challenge Of Compassionate Use In The Social Media Era


August 27th, 2014

The Development of Brincidofovir and its Possible Use to Treat Josh Hardy

Last March 4, seven-year old Josh Hardy lay critically ill in the intensive care unit at St Jude Children’s Hospital in Memphis, Tennessee with a life-threatening adenovirus infection. His weakened immune system was unable to control the infection, a complication of a bone marrow stem cell transplant he needed as a result of treatments for several different cancers since he was 9 months old.

His physicians tried to treat the adenovirus with an anti-viral agent, Vistide (IV cidofovir), but had to stop due to dialysis-dependent renal failure. They were aware of another anti-viral in Phase 3 clinical development, brincidofovir, an oral compound chemically related to Vistide. In earlier clinical testing brincidofovir had shown the potential for enhanced antiviral potency and a more favorable safety profile.

Chimerix (where one of us, Moch, was CEO), a 55 person North Carolina-based biopharmaceutical company, had previously made brincidofovir available to more than 430 critically ill patients in an expanded access program for the treatment of serious or life-threatening DNA viral infections, including adenovirus as well as herpes viruses (such as cytomegalovirus) and polyomaviruses.  This program started in 2009 as a series of individual physician-sponsored emergency INDs — investigational new drug exemptions issued in physician-certified compassionate use situations.

The program evolved via word of mouth to the extent that brincidofovir was made available under emergency INDs for more than 215 patients. During 2011, Chimerix received funding from Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA) to provide brincidofovir to an additional 215 critically ill patients for the purpose of gaining insights into the potential use of brincidofovir as a medical countermeasure against smallpox. (Department of Health and Human Services Contract No. HHSO100201100013C.  For further information on brincidofovir Study CMX001-350, see ClinicalTrials.gov Identifier NCT01143181.)

When BARDA funding ended in 2012, Chimerix stopped accepting new requests for compassionate use under its expanded access program. Although requests continued from physicians around the world, the company decided that it was in the best interests of the greatest number of patients to devote its limited human and financial resources to the clinical development pathway necessary for FDA approval of brincidofovir.

This post examines the implications of the ultimately successful campaign waged by Josh Hardy’s family to obtain access to brincidofovir for their son. We discuss several issues raised by the Hardy case, including the overarching question of whether it is fair for social media or influence of any form to play a role in determining which patients get access to experimental treatments; whether rescuing individual patients in need can be reconciled with an evidence-based regulatory approval process for new therapies; and whether there is a duty to “rescue” terminally ill patients by paying for access to experimental therapies.

Finally, we propose a new framework for regulating access to experimental treatments.

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It’s Hard To Be Neutral About Network Neutrality For Health


August 18th, 2014

Network Neutrality (NN) has been in the news because the FCC is considering two options related to a neutral Internet: Either regulation forcing NN, or an approach that creates a “fast lane” on the Internet for those content providers that are willing to pay extra for it.

Network Neutrality reflects a vision of a network in which users are able to exchange and consume data, as they choose, without the interference of the organization providing the network basic data transport services. The second option, preferential service, entertains the possibility that the Internet could become what the National Journal describes as “a dystopia run by the world’s biggest, richest companies.”

However, the problem of network neutrality is more complex. Full network neutrality could also lead to a tragedy of the commons in which application developers compete for the use of “free” bandwidth for services to win customers while clogging networks and lowering performance for all. Key stakeholders providing basic transport Internet service such as Comcast, Verizon, or AT&T, and large Internet savvy content providers like Google have a clear understanding of the debate and what they stand to gain or lose from network neutrality.

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Mental Health Reform: Treating Before Stage 4


August 11th, 2014

When I talk about mental illnesses, I often point out that as a matter of public policy they are the only chronic conditions we wait until Stage 4 – the final stage in a chronic disease process – to treat, and then often only through incarceration.

To me, it is clear why this is the case. We have adopted a behavioral standard – danger to self or others – as a trigger to treatment.

But waiting until injury or death is imminent is no way to treat a chronic health condition. David Mechanic’s thoughtful Health Affairs article, “More People Than Ever Before Are Receiving Behavioral Health Care in the United States, But Gaps and Challenges Remain,” published in the recent August issue, examines the result of this Stage 4 thinking.

Beginning with “the devastating effects on the well-being of individuals, families, and communities,” Mechanic lays out the current state of mental health care in America. Mental illnesses rob individuals of both dignity and decades of life expectancy.

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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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Disparities In Access To Palliative Care


July 30th, 2014

Editor’s note: Otis Brawley also coauthored this post. This post is part of a periodic Health AffairsBlog series on palliative care, health policy, and health reform. The series features essays adapted from and drawing on an upcoming volume, Meeting the Needs of Older Adults with Serious Illness: Challenges and Opportunities in the Age of Health Care Reform, in which clinicians, researchers and policy leaders address 16 key areas where real-world policy options to improve access to quality palliative care could have a substantial role in improving value.

Racial and ethnic disparities in health care have been well documented among minority groups with respect to access to care, receipt of care, and quality of care. As a result of these disparities, minority populations are often diagnosed with late stage illness and have inferior outcomes likely leading to increased suffering.

Little is known, however, about disparities in access to and use of specialty palliative care. Palliative care is medical care aimed at relieving suffering and providing the best possible quality of life for people facing pain, symptoms, and stresses from serious illness. Palliative care is appropriate for patients at any age or illness stage and can be provided along with curative or life-prolonging therapies.

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The Double-Faced Pain Problem: Reflections On July’s Narrative Matters Essay


July 28th, 2014

Reading Janice Lynch Schuster’s tormented account of her persistent pain and her journey through the medical maze of care in the July issue of Health Affairs, I’m reminded of how millions of Americans are living with not one, but two, pain challenges. The first is the epidemic of over-prescription; the second is the condition of endemic under-medication.

In her essay “Down The Rabbit Hole: A Chronic Pain Sufferer Navigates The Maze Of Opioid Use,” Schuster herself hints at the dual issues when she writes: “pain patients like me often feel trapped between the clinical need to treat and manage pain and the social imperative to restrict access to such drugs and promote public safety.”

People coping with chronic pain confront a double-faced problem: a society simultaneously providing too much relief and too little. Which face of the American pain dilemma any patient will experience depends on where they live, who they are, and what kind of practitioner they encounter in their pursuit of relief. As Schuster writes, the situation is perplexing, maddening, and sometimes arbitrary.

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The Medicaid Boom And State Budgets: How Federal Waivers Are Advancing State Flexibility


July 18th, 2014

Note: The authors would like to thank Erica Socker, Senior Research Associate, and Michelle Shaljian, Associate Director of Communications, for their review and editorial assistance.

According to data released by the Department of Health and Human Services, one in five Americans now receive their health insurance through a state Medicaid program. Despite this increase in enrollment, it is estimated that 6 million Americans will likely remain uninsured because 20 states have decided not to expand Medicaid as the Affordable Care Act (ACA) envisioned. There are at least four states that are considering expanding Medicaid but have yet to do so.

Medicaid expansion continues to be one of the most politically charged directives of the health care law, mainly because the Supreme Court decision left the choice to states. This decision has generated an ongoing debate about whether and how states should expand their Medicaid programs. For example, an intense debate has been underway in Virginia, over the decision to include Medicaid expansion in the state budget; putting Democratic Governor Terry McAuliffe at odds with the Republican State Legislature. Similar debates are occurring in states across the country, and are further complicated by states’ option to pursue alternative expansion approaches under a Medicaid waiver. For states that have not yet expanded the program, the success of these alternative expansion models may influence whether they can find a politically feasible path forward.

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Washington Wakes Up To Socioeconomic Status


July 11th, 2014

John Mathewson, executive vice president of Health Care Services for Children with Special Needs (HSC) – a Medicaid managed care plan in D.C. for children on Supplemental Security Income (SSI) – recently spoke at the Association for Community Affiliated Plans (ACAP) CEO Summit before the July 4 Recess.

Mathewson described what he has dubbed The Kitten Paradox: When HSC examined environmental factors for children with asthma, it found that the presence of pets in the house was a common thread, not too far behind having a smoker around. Yet, it turns out the value a cat brings by protecting from mice or spawning a litter for sale outweighs any financial costs to the family associated with an ER visit, which are often free or carry a low copayment. Thus the paradox.

An awardee at the conference, Hennepin Health, catalogued the evidence showing that reliable housing can improve health outcomes, including improving mental health and lowering emergency room and inpatient hospital utilization.

The focus of these sessions was the social determinants of health, and a lot of these safety net health plan leaders’ heads were nodding throughout. The plans, which disproportionately serve Medicaid enrollees and thus ‘dual eligible’ seniors in Medicare, know something about the importance of social determinants that the health policy community – at least in Washington – is only now slowly waking up to.

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A Health Reform Framework: Breaking Out Of The Medicaid Model


July 10th, 2014

Editor’s note: This post is coauthored by Joseph Antos and James Capretta.

A primary aim of the Patient Protection and Affordable Care Act (ACA) is to expand insurance coverage, especially among households with lower incomes. The Congressional Budget Office (CBO) projects that about one-third of the additional insurance coverage expected to occur because of the law will come from expansion of the existing, unreformed Medicaid program. The rest of the coverage expansion will come from enrolling millions of people into subsidized insurance offerings on the ACA exchanges — offerings that have strong similarities to Medicaid insurance.

Unfortunately, ample evidence demonstrates that this kind of insurance model leaves the poor and lower-income households with inadequate access to health care. The networks of physicians and hospitals willing to serve large numbers of Medicaid patients have been very constrained for many years, meaning access problems will only worsen when more people enroll and begin using the same overburdened networks of clinics and physician practices.

It does not have to be this way. It is possible to expand insurance coverage for the poor and lower-income households without reliance on the flawed Medicaid insurance model. Opponents of the ACA should embrace plans to replace the current law with reforms that would give the poor real choices among a variety of competing insurance offerings, including the same insurance plans that middle-class families enroll in today. Specifically, we propose a three-part plan that includes a flexible, uniform tax credit for all those who lack employer-based coverage; deregulation of Medicaid; and improved safety-net primary and preventive care.

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Implementing Health Reform: A Follow-Up Supreme Court Contraceptives Decision At Odds With Hobby Lobby


July 4th, 2014

On July 3, 2014, the Supreme Court decided its second contraceptive case of the 2013-2014 term, Wheaton College v. Burwell. The decision demonstrates why more Americans now believe that the justices are doing a poor job (27 percent) than believe they are doing an excellent or good job (26 percent combined), and why 76 percent of Americans believe that the justices decides cases based on their own personal and political opinions rather than legal analysis.

The Wheaton College decision seems to contradict directly the Hobby Lobby decision the Court had entered three days earlier. The Court offered virtually no justification for its change of position. Indeed, one wonders whether the men on the Court, in their haste to get out of town even bothered to read the scathing but well-reasoned dissent filed by Justice Sotomayor for the women of the Court, with which they did not engage.

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After Hobby Lobby: How Might Policymakers Mitigate The Decision’s Impact On Women And Families?


July 3rd, 2014

Editor’s note: In addition to Sara Rosenbaum, Adam Sonfield and Rachel Benson Gold also coauthored this post. 

On June 30, the U.S. Supreme Court handed down a ruling that has the potential to undermine an important provision of the Affordable Care Act (ACA) that establishes for women a federal guarantee of coverage for their full range of contraceptive methods, services, and counseling without any out-of-pocket costs. This guarantee is administered through private health plans, whether purchased in the individual market or made available through the insurers and plan administrators that provide group coverage.

The 5-4 ruling in Burrell v. Hobby Lobby Stores, written by Justice Samuel Alito on behalf of the Court’s conservative bloc, held that closely held for-profit corporations that assert a religious objection to some or all forms of contraception cannot be required to include such coverage in the health plans they sponsor for employees and their families. As emphasized by Justice Ruth Bader Ginsburg in her dissent (joined in whole by Justice Sotomayor and in part by Justices Kagan and Breyer), the Court’s decision could have serious and widespread consequences.

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Cancelled Non-Group Plans: What We Know Now That We Did Not Know In October


June 17th, 2014

In October of 2013 President Obama faced a political firestorm over the cancellation of millions of individual insurance plans — plans not compliant with the requirements of the Affordable Care Act (ACA). The Associated Press (AP) estimated that 4.8 million persons with non-group coverage had their policies cancelled, and this estimate was widely quoted in the media and the Congress. In headline stories, the media also reported that policyholders of the canceled plans were now offered alternative plans, often at premiums more than double of their current plans.

When the controversy over cancelled policies broke, no surveys were available to estimate the number and the cost of cancelled policies. In October, HealthCare.gov and many state-based marketplace websites were virtually non-functional, so assessing comparative cost and benefits of cancelled and Marketplace plans largely was precluded. In this post I highlight information from subsequent surveys and analyses conducted in late 2013 and 2014 that measure the number of cancelled plans and the comparative cost of coverage in the pre-ACA and post ACA-Markets. The next two paragraphs summarize findings.

Recent survey data indicates the number of persons affected by cancelled policies was about 1.9 million persons, less than the often cited 4.8 million estimate. When persons with group health insurance are included in the denominator, these cancellations affected less than one percent of persons holding comprehensive private insurance. The number of people with non-group policies who became uninsured following last October’s cancellation of policies is similar to what occurs in the normal churn of the non-group market.

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Thoughts On The VA Scandal And The Future


June 13th, 2014

For eight years, until May 2013, I directed the Department of Veterans Affairs (VA) medical research program from its Central Office and became familiar with the operations of the Veterans Health Administration (VHA). It was my only VA job and I felt honored to be part of the VA’s vital mission, as did most VA employees I met. Based on this experience, I have some ground level observations on the state of the VA and its future planning in light of the present scandal.

VA’s Scope and Assets

VA has three components: a large health system (VHA), a benefit center (Veterans Benefits Administration, or VBA), and the highly regarded National Cemetery Administration. All report to the VA Secretary but have different missions, issues, and management requisites. For example VHA was a pioneer in the Electronic Health Record (EHR), while VBA has had a more recent painful conversion to information technology (IT). VHA is run by the Undersecretary for Health, on whom VA Secretaries almost totally rely given their general lack of experience in health care.

VHA is divided into 21 networks and has 8.9 million enrollees (out of the 22 million U.S. veterans). It cares for 6.4 million veterans annually at over 1,700 sites of care, including 152 hospitals, about 820 clinics, 130 long-term care facilities, 300 Vet Centers for readjustment problems, and a suicide hotline, as well as homelessness and other programs. It has partly trained two-thirds of U.S physicians and made groundbreaking medical research contributions. These assets create strong constituencies for VA both within and outside the veterans’ community.

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Changing Provider Networks In Marketplace Health Plans: Balancing Affordability And Access To Quality Care


June 11th, 2014

Editor’s note: In addition to Sabrina Corlette, JoAnn Volk, Robert Berenson, and Judy Feder coauthored this post. 

Twelve percent of the complaints to California’s Department of Managed Health Care this year relate to access to care problems. In New Hampshire, consumers were upset to learn that their local hospital had been excluded from the network of the sole insurance company participating on the state’s health insurance marketplace. In reaction to concerns about narrowing networks, legislators in Mississippi and North Dakota considered “any willing provider” legislation this year.

But at the same time, the Congressional Budget Office expects narrow networks to help reduce marketplace costs by billions of dollars. Network configurations clearly offer consumers a cost-access trade-off. Narrowing networks is by no means a new trend – using network design to constrain providers’ price demands has long predated the Affordable Care Act (ACA). In the new marketplaces, insurers are using narrow networks to help keep premiums low for price-sensitive purchasers. But if a plan’s low premium reflects limited network access, its policyholders might not only face compromised quality care but unanticipated and potentially crippling financial liabilities.

Regulators are recognizing this trade-off and reconsidering network standards at the state and federal level. But regulators face a challenge: If they overly constrain insurers’ ability to negotiate with providers, consumers could face significant premium increases. On the other hand, if they ignore provider participation issues, consumers will lack confidence that there is a sufficient network to deliver the benefits promised without posing financial or quality risks.

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Sharp Increases In The Clinician Pipeline: Opportunity And Danger


June 9th, 2014

The number of health care practitioners educated in the United States has grown dramatically over the past decade. This post presents data on four key health care clinicians: nurse practitioners (NPs), pharmacists, physician assistants (PAs), and registered nurses (RNs). In some cases, the pipeline for these clinicians has more than doubled in recent years. Even if there is no further growth in the educational pipeline today, the increases in educational capacity, if continued, will lead to an increase in the available supply each year for the next 30 to 35 years.

If these practitioners are fully integrated into the delivery system and allowed to practice consistent with their education and training, this growth can help assure access to cost effective care across the nation. On the other hand, because of the 30 to 35 year tail in the growth of practitioners, there is a danger that this rapid growth could also lead to significant surpluses, which would have many negative consequences.

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