REGISTER NOW: Aligning Policy and People: Why the Time is Right to Transform Advanced Care

hands_Ingram Publishing_slideJune 21, 2016, 9am – 1pm

Wasserstein Hall, Milstein East (2036), Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

This event is free and open to the public, but seating is limited. Register now!

Description

Please join us for the inaugural event of the Project on Advanced Care and Health Policy, a collaboration between the Coalition for Advanced Care (C-TAC) and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. This conference will feature policymakers, thought leaders, family caregivers, clinicians, consumer advocates, and others working to identify the timely, practical, and actionable opportunities to transform care for people with advanced illness nearing end-of-life.

Confirmed Speakers

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TWIHL Special: Wendy Mariner Analyzes the New Wellness Regulations

By Nicolas Terry and Frank Pasquale

twihl 5x5A special TWIHL episode with analysis of the new EEOC regulations under the ADA and GINA on Employer Wellness Plans. Nic is joined by Professor Wendy Mariner. Professor Mariner is the Edward R. Utley Professor of Health Law at Boston University School of Public Health, Professor of Law at Boston University School of Law, Professor at Boston University School of Medicine, and Co-Director of the J.D.-M.P.H. joint degree program, and a member of the faculty of the Center for Health Law, Ethics and Human Rights at BUSPH. Professor Mariner’s research focuses on laws governing health risks, including social and personal responsibility for risk creation, health insurance systems, implementation of the Affordable Care Act, ERISA, health information privacy, and population health policy.

Our discussion concentrated on the ADA regulation and examined how the agency responded to comments (including ours), the concept of voluntariness, the status of EEOC v. Flambeau, Inc., data protection (including issues raised when  employers research the health of their employees), and the policy flaws in the wellness space.The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy.

Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

SCOTUS and More Surprises on Zubik

After the 2014 SCOTUS decision in Hobby Lobby, in which a closely-held for-profit employer won the argument that the federal Religious Freedom Restoration Act protected it against enforcement of the government’s contraceptives coverage mandate, all eyes have been on what SCOTUS would do in response to a challenge to the very same accommodation it toyed with as a less restrictive alternative in that case.  The Court agreed to hear a consolidated set of challenges to the accommodation brought by several religious non-profit employers who seek outright exemption from the mandate (under the case name Zubik et al.) – but then Justice Scalia passed away, leaving the Court with the unpalatable prospect of a 4-4 decision.

SCOTUS has pulled a few tricks out of its hat to avoid that possibility.  First, it surprised us by seeking supplemental briefs on a possible compromise solution, which would ostensibly allow women to access contraceptives (as the government desires) while not burdening the religious employers (as they desire).  The parties basically responded, as politely as would be expected, that some compromise was indeed possible – but not on terms the other could or would actually accept.  Nonetheless, today, SCOTUS surprised us again – seeing enough glimmer of a possible compromise to decline to decide the cases on the merits, instead returning them to the lower courts to work something out.

So what does that mean?  In my view, count it as a win for the government.  Eight out of nine circuit courts ruled in the government’s favor below, holding that the accommodation it had already offered did not substantially burden employers’ religious beliefs – which means that RFRA’s further protection, demanding a compelling government interest satisfied in the least restrictive way, does not even get triggered. These courts have no reason to change that determination now.  Even if there is a compromise that would be less burdensome on religious employers (which I don’t think there is), such a compromise is not required under RFRA unless there is a substantial burden.  And SCOTUS hasn’t said there is.

What we have here is, ironically, precisely the same result we’d have had if SCOTUS had issued a 4-4 decision.  The lower court opinions will almost certainly stand, and we’ll likely still have a bit of a circuit split. So now, we wait on a new president.  The Donald would presumably destroy the ACA/mandate entirely, whereas Hillary would hopefully be able to deliver a ninth justice that will recognize RFRA’s reasonable limits.  Religious freedom is critically important, but so too is accepting the government’s dramatic efforts to be accommodating, short of letting every religious believer be an island unto himself.

How Not to Debate Health Care Reform

Editor’s Note: This post was originally published on May 12 with portions of the essay missing. The corrected text is below.

By Ted Marmor

Presidential campaigns in the United States are not typically fought over competing manifestos, with policy details set out in reasonably clear language. Rather they are disputes among candidates about the state of the country and what values—or aspirational visions—they endorse.  And, for at least a century, most American debates about health care reform have been dominated by ideological slogans, misleading claims about financing, and mystifying labels. Republicans have exemplified the mystification this year, repeatedly mislabeling Obamacare as socialized medicine and falsely claiming it a “takeover of American medicine.”

In fairness, the Democratic primaries have generated their own version of mystification. The two candidates do agree on the goals of universal health insurance. But clarity ends there. The Clinton campaign has emphasized incremental reform possibilities and criticized Senator Sanders’ proposal of Medicare for All as unrealistic. Sanders, by contrast, has offered a compelling conception of a fairer and less expensive version of what Americans want, but no incremental steps to get to it.

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Elizabeth Sepper on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

 

This week we interviewed Elizabeth Sepper, Associatetwihl 5x5 Professor of Law at Washington University. Elizabeth’s work explores the interaction of morality, professional ethics, and law in health care and insurance. She has written extensively on conscientious refusals to provide reproductive and end-of-life healthcare In recent work, Elizabeth has argued that, in resisting compliance with antidiscrimination laws, pharmacy regulations, and insurance mandates (most prominently, the Affordable Care Act’s contraceptive mandate), businesses make claims more reminiscent of market libertarianism than of religious freedom.

Our conversation covered many aspects of conscience claims by contemporary health providers. Our timing was perfect, since HHS just finalized a rule on one of Elizabeth’s areas of expertise: prohibitions on discrimination based on race, color, national origin, sex, age or disability. Elizabeth weighed in on the rule and its implications for the future of health care.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher RadioTunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

When Global Health Norms Meet Medicaid

Special guest post by Nicholas J. Diamond

Medicaid is currently facing a timely, although largely underappreciated, challenge: rebalancing Medicaid long-term services and supports (LTSS). For context, LTSS refer to a broad range of paid and unpaid medical and personal care assistance for individuals who experience difficulty completing self-care tasks due to aging, chronic illness, or disability. According to 2013 estimates, there are approximately 12 million individuals in the U.S. who rely on LTSS, mostly paid for through Medicaid, with a projected increase to approximately 27 million individuals by 2050.

Medicaid has a historical structural bias toward institutional care, such as nursing homes, as opposed to home and community-based services (HCBS), such as home health aides, personal care, chore services, supported employment, rent and food for live-in caregiver, and nonmedical transportation, among many others. Medicaid LTSS rebalancing, therefore, shifts spending away from institutional settings and toward HCBS, which is less expensive and generally preferred by beneficiaries. States may provide HCBS through a complex panoply of federal statutory authorities, including waiver authorities, which afford states wide latitude in designing programs. As you might imagine, with flexibility comes significant variations in how states provide HCBS, which specific types of HCBS they provide, and whether, for instance, cost containment strategies available under certain authorities negatively impact access to needed services. Continue reading

Looking Towards 2030 in Patient Safety

There is a clear need for those charged with patient safety policy making to prepare for the future and to take account of emerging trends. This would be so in any commercial or professional organisation. These issues were addressed in the context of patient safety at the recent,Patient Safety Global Action Summit held in March 2016 in London. The conference was designed to mirror the discussions contained in the report  by NIHR (National Institute for Health Research), Patient Safety Translational Research Centre at Imperial College London and The Imperial College NHS Trust on the priorities and direction that the patient safety movement should follow going towards 2030.

There is a lot that is excellent in this report  which is very rich in analysis and detail. Lots of deep thinking about patient safety issues with interesting and novel ideas expressed on nearly every page.

Emerging threats to patient safety

In the report, in chapter one, it is acknowledged that there are many existing issues at the root of patient harm that have yet to be solved. Also that unfortunately trends in healthcare are likely to increase the risks to safety. The report focuses on four emerging trends: Continue reading

CPC+: Opportunities and Challenges for Primary Care Transformation

In recent days there has been a lot of action around CMS’ Comprehensive Primary Care Initiative (CPCI). First, the next phase of the program was announced, expanding the program in size and scope. Several days later, an evaluation of the first two years of the initiative was published in the New England Journal of Medicine.

The original CPCI demonstration began in October 2012 and included 502 practices in seven regions (states or smaller areas within states). The regions were determined largely by payer interest, as commercial and state health insurance plans are essential partners in this multi-payer model. The CPCI involves risk-stratified care management fees for participating practices and the possibility of sharing in net savings to Medicare (if any). In turn, the practices must invest in practice redesign around: access and continuity, chronic disease management, risk-stratified care management, patient and caregiver engagement, and care coordination across a patient’s providers, e.g., managing care transitions and ensuring close communication and collaboration.

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What we know about how the structure of Marketplaces and Medicaid expansion affect enrollment

By Emma Sandoe

It is fairly obvious that states that expanded Medicaid saw greater enrollment in Medicaid after the opening of the Health Insurance Marketplaces in October 2013 than states that did not expand. CMS has been releasing monthly reports that indicate just that.

This also corresponds to the reductions in uninsurance. States that expanded Medicaid clearly have seen greater reductions in uninsurance than states that elected not to expand. The US Census Bureau recently posted the maps below in their blog “Research Matters.” Here is a map of the uninsurance reductions:

With the exceptions of states like Massachusetts that have already high levels of Medicaid expansion, it’s clear which states have chosen to expand Medicaid and which ones have not, but if you need the context, here is a map of states that have expanded Medicaid:

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Little Sisters’ Case: A Forgotten Voice

By: Matthew Ryan

I love the Little Sisters of the Poor. As an undergraduate student, I fulfilled my public health program’s service requirements by volunteering at their nursing home in St. Louis. Each week, I would drive from my pristine, Jesuit college campus to the neglected part of the city. The sisters’ home was on an abandoned block without a street sign. The sister’s “neighbors” were a few burnt-out homes and mostly over-grown lots.

Inside, the nuns housed and loved the most vulnerable. I volunteered on the floor with residents suffering from dementia. I remember one nun in particular, Sister Isabella, who had given her entire life to caring for our elderly poor. Every hour or so, Sister Isabella would greet one resident who could no longer speak audibly nor open her eyes. Sister Isabella would hug her, sing to her, and often take her outside to feel the sunshine. This, in addition, to cleaning up after the residents, leading prayer before meals, and ensuring each resident got out of his or her bed each day.

Sister Isabella—and the Little Sisters in general—have remained imprinted in my memory. They have been a tremendous example to follow. When the rest of society, many Catholic churches included, had given up on the “least of our brothers and sisters,” the Little Sisters quietly went about doing the work of God. My admiration for them has made the recent Supreme Court case—and the battle over the Affordable Care Act’s contraceptive coverage—all the more difficult. Continue reading

Health Care Politics in the US South

by Emma Sandoe

Courtesy of Vanderbilt Center for Medicine, Health, and Society http://www.vanderbilt.edu/mhs/the-politi…

This month I attended the Politics of Health Care in the US South conference held at Vanderbilt. This conference was cosponsored by the Anna Julia Cooper Center at Wake Forest. Instead of a lengthy conference summary, I’ll attempt to capture some of the key lessons I learned to better understand the politics of the South.

What is the South?

There is no other region of the country with such a strong personal identification and complex emotional reaction as the South. Californians don’t identify as “Westerners;” “New Englander” inspires connotations of sleepy scenes of snow and hot chocolate; and while you may get a rare character that strongly identifies as a “Midwesterner,” there is a clear difference in the passion that a Minnesotan speaks of their homeland compared to a Tennessean. But despite the fact that the words “the South” strikes passion in its residents, historical and modern important moments in our nations conversation on race, and a specific cultural identity, there is really no common definition of the geographic South. Modern politics make the inclusion of Maryland and DC counter to our understanding of the deep red political vote. Texas and Florida have their own unique identities and their vast populations often skew any analysis of the region. Each unique issue in the South first requires a definition of what geographic region you are discussing.

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The Unintended Uninsured: The Affordable Care Act’s Coverage Gap

[Cross posted from the Harvard Law and Policy Review]

By Julian Polaris

This is a golden age for access to healthcare in America. In 2015, over 90% of Americans had health coverage, the highest insurance ratein the 50 years the federal government has collected insurance data. This astonishing progress is due in large part to the Affordable Care Act (ACA): President Obama recently announced that 20 million people are covered thanks to the ACA. The victory is bittersweet, however: had the ACA been implemented as designed, an additional three million people would have insurance today. This is the story of the “coverage gap,” a crack in the ACA created by the Supreme Court and left unrepaired in nineteen states. A crack so wide that three million low-income people have fallen through it.

The ACA, as originally passed, aimed to increase access to health coverage in two main ways. First, the Act expanded Medicaid, the public health plan for people with low income. Previously, most states had limited Medicaid eligibility to specific groups like children and pregnant women. The ACA enlarged and standardized the Medicaid program to cover all people who earn up to 138% of the federal poverty level (FPL). The federal government picks up 90% of the cost of healthcare services for newly eligible beneficiaries, whereas costs in traditional Medicaid are split closer to 50-50.

Second, the ACA established the health insurance “exchanges,” portals in each state where consumers can shop for standardized plans that aren’t tied to a particular employer. Federal tax credits are available to subsidize exchange coverage for those earning 100 to 400% of the FPL. Continue reading

The Petrie-Flom Center & Coalition to Transform Advanced Care Launch “The Project on Advanced Care and Health Policy”

The Project on Advanced Care and Health Policy will foster development of improved models of care for individuals with serious advanced illness nearing end-of-life, through interdisciplinary analysis of important health law and policy issues.

March 28, 2016 – The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Coalition to Transform Advanced Care (C-TAC) today announced a new collaboration, The Project on Advanced Care and Health Policy.

This initiative is prompted by the fact that current health law policy and regulation, developed largely in a fee-for service environment with siloed providers, creates barriers that may impede widespread adoption of improved models of care for those with advanced illness. The Project will seek to address this problem through policy and research projects that will identify and analyze these barriers, and propose policy solutions that promote development and growth of successful programs. This may entail developing proposed regulatory approaches for the advanced care delivery model that could be adopted by policymakers at the state and federal levels, as well as exploration of potential payment methodologies for this model of care.  Continue reading

Tax exemptions and nonprofit hospitals: An uncertain future

Of the 4,926 community hospitals in the United States, the majority, about 58 percent (2,870) are not-for-profit. About 21 percent (1,053) are for-profit, and the remainder are owned by state and local governments. Hospitals serve communities by caring for the sick, but they’re also often billion dollar enterprises and tension between the mission and business model of nonprofit hospitals is growing.

Nonprofit hospitals are expected to benefit their community in exchange for their tax-exempt status. Hospitals have most commonly fulfilled this obligation by providing uncompensated care, or charity care. However, this has historically been poorly regulated. A 2013 study found that on average nonprofit hospitals spent 7.5 percent of their operating expenses on community benefit activities, and 85 percent of that was charity care. However, there was major variation in the amount allocated to community benefit, ranging from 1 percent to 20 percent.

The Affordable Care Act introduced new community benefit reporting requirements for nonprofit hospitals in an effort to bring more clarity and accountability to the amount and quality of “community benefits” delivered in exchange for 501(c)3 tax exemption. The value of the nonprofit tax exemptions for hospitals is significant: it was estimated at almost $25 billion in 2011. For states and municipalities in particular, the foregone tax revenue is nontrivial, especially as their taxes bases were squeezed by the burst of the housing bubble in 2008. It should be little surprise, then, that municipalities have started to scrutinize the tax exemptions for nonprofit hospitals.

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The Economics Of Paying For Value

This new post by Nancy Beaulieu, Michael Chernew, Soren Kristensen, and Meredith Rosenthal appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

The notion that the American health care system should transition from paying for volume to paying for value has become nearly ubiquitous. There is a broad consensus that health care providers should be paid more if they deliver higher value care (i.e. care that results in substantial health gains per dollar spent).

These beliefs have led to a proliferation of value-based payment programs in both public and private sectors. For example, at the beginning of 2015, Sylvia Burwell announced the federal government’s commitment to tie 90 percent of fee-for-service Medicare payments to quality or value measures by 2018. In January of 2015, a newly formed alliance of health care providers, insurers, and employers called the Health Care Transformation Task Force committed to shifting 75 percent of their business to contracts that provide incentives for quality and efficiency by 2020.

The details of existing value or quality-based payment programs vary enormously and without regard to any conceptual framework. For example, they vary in the size of incentives and the measures used. They also vary in whether quality payments are contingent on financial savings and whether the value-based payment model is budget neutral. Even the term value is inconsistently defined. […]

Read the full post here.

Breaking Good? The Arc Of Antitrust Policy In The Health Sector

This new post by Barak Richman appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

It appears that 2016 will follow 2015 as another year of massive consolidation in the health care sector. It therefore follows that 2016 will, also like 2015, be another year in which assorted health care industries receive significant antitrust scrutiny. Against this backdrop, it is timely and revealing to examine the current state and trajectory of antitrust law as it intersects and shapes health care policy.

Beginning in the late 1980s, when hospitals and hospital systems started an intense consolidation trend that continues today, many were challenged by the Federal Trade Commission (FTC) for creating anticompetitive and therefore illegal pricing power. Yet the FTC was unsuccessful in convincing courts that this was a harmful trend, and the Commission earned a costly, long losing streak, suffering defeats in each of six landmark cases between 1994 and 1999 (Note 1). The district courts reasoned that the hospitals’ mergers would provide better and more efficient care, that patients would travel to obtain cheaper care, and in any event, because the hospitals were nonprofit, they would not exercise market power to increase prices.

All these predictions have been proven incorrect. Hospital mergers (including those involving nonprofits) have significantly increased prices, and there has been no evidence of increased efficiencies. In fact, evidence suggests that, because the administration of health insurance both reduces the impact of marginal price increases and limits demand in close substitutes, hospital monopolists are even more costly than “typical” monopolies. One significant development in 2015 is new research which revealed that cost variation in the US is largely determined by hospitals market power. The string of FTC losses and the consequent wave of hospital consolidations can only be described as a collective and massive failure of antitrust policy. […]

Read the full post here.

Medicaid Expansion Through Section 1115 Waivers: Evaluating The Tradeoffs

This new post by Rachel Sachs appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

Nearly six years after the passage of the Affordable Care Act (ACA), health law and policy experts continue to painstakingly track the progress of the Act’s Medicaid expansion. The original intention of the ACA was to expand Medicaid in every state, leading to gains in coverage by all individuals below a certain income.

However, the Supreme Court’s 2012 ruling in National Federation of Independent Business v. Sebelius(NFIB) invalidated the original expansion as unconstitutionally coercive, effectively making the Medicaid expansion voluntary for states. As of this blog post, just 32 states including DC have expanded Medicaid pursuant to the ACA.

Most of the states that have expanded Medicaid thus far have done so through the standard procedure, following the statutory guidelines set forth by the ACA and the Centers for Medicare & Medicaid Services (CMS) and incorporating the newly eligible enrollees into their existing programs as a new beneficiary group. But some states have successfully negotiated customized expansions with CMS through the use of the Section 1115 waiver process, seeking to expand Medicaid only on their terms. […]

Read the full post here.

Intelligent Transparency and Patient Safety: New UK Government Patient Safety Plans Launched

By John Tingle

One thing is clear when commentating on patient safety developments in the UK is that there is hardly ever a dull moment or a lapse of activity in patient safety policy development .Something always appears to be happening somewhere and it’s generally a very significant something. Things are happening at a pace with patient safety here.

On the 3rd March 2016 the Secretary of State for Health,The Rt Honourable Jeremy Hunt announced a major change to the patient safety infrastructure in the NHS with the setting  up from the 1st April 2016 of the independent Healthcare Safety Investigation Branch. In a speech in London to the Global Patient Safety Summit on improving standards in healthcare he also reflected on current patient safety initiatives.This new organisation has been modelled on the Air Accident Investigation Branch which has operated successfully in the airline industry. It will undertake, ‘timely, no-blame investigations’.

The Aviation and Health Industries
The airline industry has provided some very useful thinking in patient safety policy development when the literature on patient safety in the UK is considered. The way the airline industry changed its culture regarding accidents is mentioned by the Secretary of State in glowing terms. Pilots attending training programmes with engineers and flight attendants discussing communications and teamwork. There was a dramatic and immediate reduction in aviation fatalities which he wants to see happening now in the NHS. Continue reading

Fight The Urge To Criminalize Opioid Addiction Behaviors

This new post by Rebecca Haffajee appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

It’s well known that the U.S. is in the midst of a prescription opioid overdose and abuse epidemic. Adverse outcomes from prescription opioid abuse have dramatically escalated over the past decade and a half, with fatal prescription opioid overdoses roughly quadrupling and emergency department visitsinvolving prescription drugs (mostly opioids) more than doubling.

Outrageous statistics—such as that opioids were involved in almost 29,000 drug overdose deaths in 2014, or that 46 people die from a prescription opioid overdose every day—have less “shock” value now than they did several years ago. Moreover, the opioid crisis has become personal: many (including presidential candidates) have experienced a close friend or family member struggle with addiction. […]

Read the full article here.

Social Justice and Ethics Committees in Heath Care: Core to our Mission or None of our Business? Harvard Medical School’s 2016 Bioethics Conference

Register now for the Annual Bioethics ConferenceSocial Justice and Ethics Committees in Heath Care: Core to our Mission or None of our Business?

April 14, 2016

Joseph B. Martin Conference Center
77 Avenue Louis Pasteur, Boston, MA 02115

This multidisciplinary program is co-sponsored by the Center for Bioethics at Harvard Medical School and the Petrie Flom Center at Harvard Law School to inform and deliberate with health care professionals, bioethicists, attorneys, and the public about how to address social justice issues in health care—such pressing problems as worsening drug shortages, continuing racial inequities, providing health care for refugees, uninsured and undocumented persons, and the like.

Using selected examples we will discuss the efforts of health care administrators and others to identify and address such large scale health system problems. Is there a role for ethics committees in handling social justice issues—should the attention of hospital ethicists and ethics committees expand to address broader institutional policies and programs? Faculty experts and participants will describe successful efforts to address specific problems and engage in thoughtful discussion with participants about strategies and struggles of ethic committees that move beyond individual case consultation to organizational ethics.

Support for this conference has been provided by Oswald DeN. Cammann Fund at Harvard University.

Register at http://conta.cc/21ojHQQ

AGENDA:

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