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Last Build Date: Thu, 30 Mar 2017 17:50:39 +0000


Our Climate Change And Health “Moment”: How Philanthropy Can Help

Thu, 30 Mar 2017 17:50:39 +0000

Some would say that the climate change and health connection is having its “moment.” It could not have arrived too soon. Environmental funders have, to a large extent, provided the primary philanthropic support for fighting climate change. The money spent annually by foundations and individual philanthropists has been directed toward wringing carbon out of our energy systems and to other measures that will slow our inexorable path toward a warmer world. Funders have come together to create organizations like ClimateWorks Foundation, a funders’ collaborative that has helped shape philanthropy’s response to climate change. And while some foundations, including Bloomberg Philanthropies, the William and Flora Hewlett Foundation, and the David and Lucile Packard Foundation (where I am currently a Visiting Scholar) have long understood how climate change affects their other programmatic work, health foundations, by and large, have not seen climate change as an area worthy of major investment. That may be changing, though—climate change is the existential threat of our time, and health philanthropists are starting to realize that climate change has the ability to overwhelm the substantial progress we have made in improving human health and extending longevity. Witness the recent Climate & Health Meeting held at the Carter Center, in Atlanta, Georgia, in February. This one-day conference assembled an international group of health and climate experts to learn more about the dramatic impact of climate change on human health as well as on health systems. The conference was organized by former Vice President Al Gore’s Climate Reality Project, the American Public Health Association, and the Harvard Global Health Institute, with funding from the Turner Foundation. (This conference replaced a three-day session that was to be hosted by the Centers for Disease Control and Prevention but was canceled following November’s presidential election.) A few stark take-aways from that conference at the Carter Center: The effect of climate change on human health is well documented, but the enormity of this impact is now being better understood—increased heat and humidity, vector-borne diseases, and degraded air and water quality all could lead to enormous public health challenges; Rising sea levels and extreme weather events threaten health systems around the world, as was graphically demonstrated in the aftermath of Hurricane Sandy and the 2011 Joplin, Missouri, tornado, which destroyed St. John’s Regional Medical Center; We are not adequately training the next generation of public health professionals to address climate change and health; Beyond their effects on physical health and the need to build more resilient health systems, changing weather patterns and weather variability are being recognized as important contributors to mental health issues. And, as is often the case, those most affected by the health implications of climate change are the ones least prepared to cope—the poor, the elderly, and children. In a call for increased philanthropic funding and cooperation, Hewlett Foundation President Larry Kramer recently noted, “Less than two percent of philanthropic dollars are currently spent in the fight against climate change. . . .” With the effects of climate change being felt more and more with each passing day, the time has come for funders to evaluate their portfolios and look for investment that can protect the gains we have made. The broader public health community is increasingly exploring how it can make a difference. This week in Chicago, the John D. and Catherine T. MacArthur Foundation, the Robert Wood Johnson Foundation, the Rockefeller Foundation, the Packard Foundation, the Children’s Investment Fund Foundation (in the United Kingdom), and the ClimateWorks Foundation hosted a day-long session on the climate/health nexus, which included many regional and global health funders. The American Public Health Association will be devoting its annual meeting in November to climate and health. And there[...]

ACA Round-Up: Bill Would Allow Use Of Tax Credits For Off-Marketplace Plans And More

Thu, 30 Mar 2017 15:25:47 +0000

Only one insurer is offering coverage in 32 percent of the counties in the United States, which together include 21 percent of the nation’s population. In five states—Alabama, Alaska, Oklahoma, South Carolina, and Wyoming—there is only one insurer participating in the state’s online marketplace. Given the current political, regulatory, and financial uncertainty, there is a very real possibility that some counties may have no marketplace insurers for 2018. On March 29, 2017, Senators Lamar Alexander and Bob Corker (both Republicans from Tennessee) put forth a proposal to address this situation. The proposal is similar, but not identical, to legislation proposed by Senator Alexander and seven other Republican Senators in 2016. In addition to this bill, other recent ACA-related developments include a FAQ on permissible consumer information gathering by agents and brokers, an interim order in one of several risk corridor payment litigations, and OIG plans to investigate the effect of the administration’s curtailment of enrollment efforts at the end of the 2017 open enrollment period. The Alexander-Corker bill would apparently allow individuals who live in a county in which the Department of Health and Human Services (HHS) certifies that no insurers are offering qualified health through an Affordable Care Act marketplace to use their premium tax credits to purchase any individual market plan approved for sale in the state. Individuals living in such counties would also be exempted from the individual responsibility requirement. The legislation would only apply through the end of the 2019 plan year. Many of the ACA’s requirements apply to all individual market plans and not just marketplace qualified health plans. Individual market insurers cannot impose preexisting condition exclusions or lifetime or annual dollar caps and all must cover the essential health benefits, limit out-of-pocket costs, and comply with the ACA’s actuarial value metal level requirements. All individual market plans must also comply with state consumer protections, such as state network adequacy and marketing requirements. It may be that the bill’s intention would be to allow coverage that does not currently qualify as minimum essential coverage—such as short-term, fixed indemnity, or specified disease coverage—to be paid for using premium tax credits. These products can be underwritten for health status, exclude preexisting conditions, omit essential health benefits, and impose annual and lifetime limits, and are lightly regulated by state law. They are not “individual health insurance coverage” under federal law. Allowing premium tax credits to pay for them would radically undermine the protections offered by the ACA. The same would be true if premium tax credits could be used to pay for grandfathered or “grandmothered” coverage that is also not subject to ACA protections — and not available to new enrollees. “Qualified health plans” that can currently be paid for by tax credits plans must meet additional requirements beyond those that apply to individual market plans generally, such as federal network adequacy and essential community provider coverage requirements and various accreditation and quality requirements. These are important consumer protections which would be lost under the proposal for enrollees who would have to enroll in off-marketplace plans. Marketplace insurers must also pay marketplace user fees, set at 3.5 percent of premiums for states. Some insurers have left the ACA marketplaces but continued to sell individual market coverage, perhaps to avoid these fees and the additional consumer protection requirements. But if insurers who sell off-marketplace plans were required to sell their plans to any premium tax credit eligible consumers (as they would be under guaranteed availability requirements) in the absence of an individual responsibility requirement, insurers may well decide to leave the individual market altogether. There are also serious practical[...]

Help Wanted: Cost-Effectiveness Research For Health And Wellness

Thu, 30 Mar 2017 14:47:02 +0000

National health expenditures represented nearly 18 percent of the U.S. gross domestic product (GDP) in 2015, while efforts to limit cost growth continue to be central objectives for public and private payers alike. Dissemination of research on the evidence base for clinical practice is an important strategy for persuading policymakers, providers, and patients that some things in medicine are not worth doing: they create too much risk, have unacceptable side effects, lack adequate effectiveness, and even, occasionally, that they are too costly for the benefits they confer. Evidence on the latter is derived from cost-effectiveness studies that allow comparison of the value for money of an intervention or program when compared to one or more alternative health-promoting interventions. The use of cost effectiveness analysis (CEA) in U.S. policy-setting environments has a checkered history given perceptions that the methodology lacks transparency, that it is applied to some interventions and not others, and that it would be used to support health care rationing. Nonetheless, the annual publication of CEAs has increased more than 10 fold since the 1990s, the lion’s share of which have been studies of the cost-effectiveness of clinically delivered prevention and treatment services. Studies that focus on non-clinically directed health promoting interventions such as tobacco or sugar taxes, or placement of urban greenways are in short supply in spite of the fact that a robust literature has documented that health care’s impact on population health is dwarfed by social and environmental factors. Expert Panels Seek to Improve and Standardize Economic Evaluations Responding to lack of uniformity and accompanying difficulties in interpreting CEAs, the U.S. Department of Health and Human Services appointed in 1993 an expert panel to review methods and develop recommendations to improve the quality and standardization of CEAs intended to inform decisions about the efficient allocation of clinical and population health-directed resources. The report of the first U.S. Panel on Cost-effectiveness in Health and Medicine issued in 1996 has guided the field over the past two decades. Last fall, a Second Panel on Cost Effectiveness in Health and Medicine provided an update that reviews, and in certain instances revises, the first Panel’s recommendations, covering innovations in methods and expanding the discussion of areas such as evidence synthesis and ethical issues. Although the current report authoritatively provides a framework for cost effectiveness evaluation that should guide the field for many years, its detailed discussions focus largely on analyses of health care directed at individuals rather than at analyses that examine health care systems or broader determinants of health. What are the costs, where are the savings? It depends on the perspective The first panel recommended the “societal” perspective as the default perspective to take for a “reference case” analysis, a standard set of methods to serve as a point of comparison across CEAs that cross populations and/or illnesses. The societal perspective is the most comprehensive perspective, incorporating all costs and all effects regardless of who incurs them, and regardless of whether the costs and effects are within or outside of the health sector. The new report recommends the addition of a “health care” perspective for reference case analyses. On the cost side, the health care perspective limits the accounting of costs (and savings) to those reimbursed by third party payers or paid out-of-pocket by patients. It does not require charting costs or savings that occur in non-health care sectors. The current panel recommends use of an “impact inventory” that lists all consequences of an intervention, within and outside of the formal health care system. It is intended to capture the costs/savings and effects of a health intervention on sectors including social services, education, housing, and environment,[...]

Health Affairs Web First: ACA Risk Adjustment And Reinsurance Were Well Targeted In First Two Years

Wed, 29 Mar 2017 20:13:57 +0000


Under the Affordable Care Act (ACA) insurers are barred from varying their coverage offers based on an applicant’s health status. In an effort to make the costs of enrolling both healthy and sick people equivalent for health plans, the ACA established a risk adjustment program in 2014.

A new study, released by Health Affairs as a Web First, examined results from the 2014 and 2015 risk adjustment and reinsurance programs for ACA-compliant individual market plans, to evaluate how risk adjustment and reinsurance transfers varied across insurers and to assess how these program payments compared across insurers given their level of per enrollee claims costs. According to the authors Paul D. Jacobs, Michael L. Cohen, and Patricia Keenan,  for the 30 percent of insurers with the highest claims in 2014 and 2015, before risk adjustment, claims—excluding administrative expenses—exceeded premium revenues by $90–$397 per enrollee per month. After revenues from risk adjustment and reinsurance were incorporated, this effect was reversed, with revenues exceeding claims by as much as $49 per enrollee per month.

To obtain their results, the authors analyzed insurer-level data in each state collected by the Centers for Medicare and Medicaid Services (CMS). “The risk adjustment and reinsurance programs were relatively well targeted in the first two years,” the authors concluded. “While there is ongoing discussion regarding the future of the ACA, our findings can shed light on how risk-sharing programs can address risk selection among insurers—a pervasive issue in all health insurance markets.”

Jacobs and Keenan are affiliated with the Agency for Healthcare Research and Quality; Cohen is with the Centers for Medicare and Medicaid Services.

This study will also appear in Health Affairs’s April issue.

Transgender Health Equity: Patients Say Providers Lack Expertise And Understanding Of Transgender Health Needs

Wed, 29 Mar 2017 14:18:25 +0000

For the past five years, Massachusetts has mandated that insurers provide coverage for medical services related to the health of transgender people, including gender-affirming medical services. But it was not clear how well the mandate was working or whether people were able to access care now that services were covered. Were insurers covering the right services? What barriers were being encountered? Harvard Pilgrim Health Care Foundation’s new program, the Health Equity Roundtable, set out to find answers to these questions by bringing together transgender men, transgender women, and transgender youth, along with parents, advocates, and clinicians to discuss the issues patients encounter in trying to access high-quality health services. Hosted by a well regarded local health center as a neutral convener, the roundtable drew a diverse group of transgender stakeholders who were eager to share their experiences about health care and health coverage. Thirty-three people participated in this first session, as well as two Harvard Pilgrim executives. What we discovered are numerous areas in which the health care system in Greater Boston fails the needs of transgender individuals. The findings are highlighted in Harvard Pilgrim Health Care Foundation’s new report on Transgender Health Care in Greater Boston. Shortage Of Providers The report identified a serious shortage of providers who can sensitively and competently provide care—even routine care, such as annual physicals or gynecological care—to transgender patients. All participants felt that health care professionals lacked even basic knowledge about trans health issues, and clinicians themselves reported a lack of training related to trans health across all professional disciplines. It was often difficult for patients to get referrals to health care and mental health professionals competent to provide care, and even with referrals, patients reported that there were not enough skilled providers to provide care. Good primary care was not easy to find, even for patients who did not require medical services related to trans health. Many otherwise capable medical practices were not comfortable with or competent in providing care for trans patients, participants said. Long Waits Participants described long wait times to access doctors and other clinicians with experience in caring for transgender people. This issue was especially problematic for transgender children, who must begin puberty-blocking drugs within a few months of achieving certain growth milestones. With the wait to see a competent pediatric endocrinologist being potentially longer than a year, the inability to access care in a timely manner can have lifelong negative effects on the patient. Difficult-To-Understand Coverage Participants said it was often difficult and confusing to learn what was and was not covered by a particular insurance plan. Since services related to gender cross several medical specialties, information from insurers might be scattered and difficult to find. Getting approvals for care was often difficult, and it was not always clear when approvals were needed or from whom. Accessing Quality Care For parents, there were a number of issues that made getting care for their children difficult, including the fact that there were very few pediatric endocrinologists who were competent to provide assessments and care for children and adolescents. Some parents reported encountering clinicians who exhibited a lack of knowledge about gender in developing children. Bias and prejudice also emerged as powerful themes that could create an often hostile and anxiety-producing climate in the health care setting. Participants said they felt especially vulnerable in emergency rooms, which led to patients avoiding seeking care when needed. Transgender patients who were part of a racial or ethnic minority were seen as being at a significant disadvantage due to factors including racism, pove[...]

Physician Burnout Is A Public Health Crisis: A Message To Our Fellow Health Care CEOs

Tue, 28 Mar 2017 14:58:39 +0000

The Quadruple Aim recognizes that a healthy, energized, engaged, and resilient physician workforce is essential to achieving national health goals of higher quality, more affordable care and better health for the populations we serve. Yet in a recent study of U.S. physicians, more than half reported experiencing at least one symptom of burnout—a substantial increase over previous years—indicating that burnout among physicians is becoming a national health crisis. Leadership is needed to address the root causes of this problem and reposition the health care workforce for the future. The authors of this paper—the CEOs of our respective institutions—are committing to do just that. Reasons For Physician Burnout Burnout is an experience of emotional exhaustion, depersonalization, and feelings of low achievement and decreased effectiveness. Although the focus of this blog is physicians, burnout is also a serious problem for nurses and other health care workers. National studies indicate that burnout is more common in physicians than U.S. workers in other fields and that the gap between physician burnout and other workers’ experience is increasing. This difference is not because of physician shortcomings. The physician selection process is rigorous and eliminates those unable or unwilling to accept this lifestyle. Most physicians are altruistic and committed to their profession. They are taught to address complex problems and to embrace challenges, including grueling training, ongoing night call, and long work hours. The spike in reported burnout is directly attributable to loss of control over work, increased performance measurement (quality, cost, patient experience), the increasing complexity of medical care, the implementation of electronic health records (EHRs), and profound inefficiencies in the practice environment, all of which have altered work flows and patient interactions. The result is that many previously well-adjusted and engaged physicians have been stressed to the point of burnout, prompting them to retire early, reduce the time they devote to clinical work, or leave the profession altogether. Why Burnout Matters The consequences of physician burnout are significant, and threaten our U.S. health care system, including patient safety, quality of care, and health care costs. Costs are impacted by burnout in direct ways (e.g. turnover, early retirement, less than full time work) and indirect ways (e.g. poor quality , including medication and other errors, unnecessary testing and referrals, greater malpractice risk, and possibly higher hospital admissions/readmissions). Prospective longitudinal studies from the Mayo Clinic demonstrate that for every 1-point increase in burnout score, there is a 43 percent increase in likelihood a physician will reduce clinical effort in the following 24 months. The experience from Atrius Health suggests that replacing a physician who retires early or leaves to pursue other career opportunities can cost between $500,000 and $1 million due to recruitment, training, and lost revenue during this time. All of this is in addition to the significant toll, sometimes with tragic consequences, that burnout exacts on physicians and their loved ones. The high level of burnout among physicians should be considered an early warning sign of dysfunction in our health care system. Professional satisfaction for physicians is primarily driven by the ability to provide high-quality care to patients in an efficient manner. Dissatisfaction is driven by factors that impede this effort, including administrative and regulatory burdens, limitations of current technology, an inefficient practice environment, excessive clerical work, and conflicting payer requirements. High levels of physician burnout can thus be seen as an indicator of poor performance by the underlying system and environment. The Role Of Technology In Driving Burnout One of [...]

Five Lessons From The AHCA’s Demise

Mon, 27 Mar 2017 15:52:37 +0000

While the keyhole of history has had insufficient time to bring the failed launch of the American Health Care Act (AHCA) into focus, it’s not too soon to begin learning some of the lessons it can teach us. Legislative efforts have a lifespan but our health care system does not. So whether we are still rejoicing or recriminating, let’s take a look at some timeless principles we can apply to the ongoing effort to improve health care in the United States. 1. Nothing is Inevitable Remember how we were all told Affordable Care Act (ACA) repeal would be on the President’s desk on Inauguration Day? After all, Republicans had already voted for it several dozen times, most recently in January 2016 in an attempt to override President Obama’s veto. Now that they had control of the White House, what could stop them? As I pointed out in my Health Affairs Blog post last December predicting ACA repeal would fail, however, there’s a difference between making a political statement and enacting real policy. The latter is invariably complex and time-consuming, creating vulnerabilities and pitfalls both known and unknown at the outset. While a cornerstone of tried and true policymaking is to leverage the “strategy of inevitability”—more than seven years ago, the ACA campaign itself vigorously deployed just such a strategy—the underlying premise of that strategy is always inherently false. So the next time someone tells you you’ve got to “get on board” because a certain bill is guaranteed to pass, you’ll know you have other options, and that person probably knows it too. 2. Stakeholders Matter While, in my prior piece, I did lament the health care community’s dormancy in the aftermath of the November 8 election, I also anticipated that it would eventually wake up to resist broad ACA repeal. And resist we did. Virtually every hospital and hospital group, every physician group, nurses, patient groups representing the young, old, disease-stricken, and disabled, and many others fervently opposed AHCA. They added analysis of AHCA’s impact on them, as Governors did regarding its impact on their states. At the end of the day, this was simply a bad bill. Stakeholders figured it out and acted when it counted. Republicans in Congress, believing they had a political mandate to move quickly, truly thought they could ignore these objections. But the stakeholder message spread and town halls filled up; protests lined district offices; opposition letters, phone calls, and tweets, poured in. Ultimately, on the day AHCA was originally supposed to get its final House vote, a Quinnipiac University poll came out showing only 17 percent of the public supported the bill, while 56 percent opposed it, a startling gap rarely seen in any bona fide political polling. By the time Republicans realized they had to start paying attention to stakeholder concerns, it was too late. The bill was already drafted and introduced and, as the White House and House leadership repeatedly threatened, members were going to be forced to vote ‘up’ or ‘down.’ Clearly, for too many by then, ‘down’ was looking like a better choice than ‘up.’ 3. The ACA Stole Most of the Good Conservative Ideas While it was lambasted by Republicans as the manifestation of a Marxist dystopia, the truth of the ACA is that it is a very moderate law. This one is personal for me. As Health Policy Counsel to then-Finance Committee Chairman Max Baucus in the prelude to President Obama’s election, I know the pains he took to build bipartisan consensus. In 2008, he negotiated with Republican counterparts on reforming the market for small businesses, in what became the SHOP Act component of the ACA (drawing from legislation originally co-led by Republican Olympia Snowe). He convened an all-day, fully bipartisan Prepare to Launch summit to query experts and debate ideas. He released a series of white p[...]

Moving AHRQ Into The NIH: New Beginning Or Beginning Of The End?

Mon, 27 Mar 2017 14:45:14 +0000

On March 16, President Trump released his administration’s blueprint for the discretionary portion of the 2018 federal budget. This document is the administration’s signal of its priorities to Congress which is responsible for passing a budget for the president to sign into law. Embedded within this budget was a proposal to dissolve the Agency for Healthcare Research and Quality (AHRQ) as a freestanding agency within the Department of Health and Human Services and to move its activities within the National Institutes of Health (NIH). No additional comment was provided in the budget as to how that re-organization would be reflected within the NIH’s structure nor was there any specific budget recommendation for AHRQ beyond the $5.8 billion cut that was included in the budget for the NIH as a whole. For almost three decades, AHRQ or its predecessor, the Agency for Health Care Policy and Research (AHCPR), has been the scientific home at the federal level for the health services and primary care research communities. Through its convening, communication, and funding functions AHRQ has been an organizing voice setting the research direction for these fields. AHRQ’s authorization from Congress ties research funding to a policy and practice agenda including a focus on quality improvement, patient safety, and primary care as a foundational component of the health care system. The linking of AHRQ’s research funding with a directive to implement findings from this research has increased the relevance and impact of the agency’s work. It has also made the agency a target for complaints and elimination by those who perceive that findings and recommendations supported with agency resources threaten professional autonomy and practice reimbursement. Slow Growth And A Crowded Field These attacks have not succeeded in eliminating AHRQ, but they have contributed to its slow financial growth over time. In 2016, AHRQ’s Congressional budget appropriation was $334 million, which was a $30 million decrease from the prior year and equal to approximately 1 percent of the NIH budget for the same time period. While AHRQ’s growth has been stunted over time, other federally supported research organizations have expanded into the area of health services research. The Affordable Care Act (ACA) re-assigned AHRQ’s responsibility for conducting comparative effectiveness research to the newly established Patient-Centered Outcomes Research Institute (PCORI) which in 2016 had an annual research budget of more than $500 million. The ACA also established the Center for Medicare and Medicaid Innovation (CMMI) with an average budget of $1 billion per year to do demonstrations and evaluations of delivery system innovation, a task that also had its origins at AHRQ. Even the NIH now spends approximately $1.5 billion per year on health services research-related projects. As a field of inquiry, health services research is in the midst of a diaspora from its once unifying home at AHRQ. AHRQ at one time provided and maintained a shared narrative for collective action. This role has proven to be more difficult for AHRQ to sustain as resources and responsibility have been dispersed across multiple organizations. Individual researchers have benefited from an infusion of funds, but the parsing of these resources among multiple agencies with varying agendas has muddled the message of what the research is aiming to accomplish. Proposed Cuts And Potential Opportunities The coupling of a potential re-organization of AHRQ within the NIH with a proposal for a major budget cut to the NIH should raise significant warning flags for the health services and primary care research communities. It is critical that stakeholders for these communities make clear to Congress the conditions necessary to ensure that such a re-organization could be the foundation for progress — and [...]

‘I’m Willing To Try Anything’: Compassionate Use Access To Experimental Drugs And The Misguided Mission Of Right-To-Try Laws

Mon, 27 Mar 2017 13:48:00 +0000

Some patients facing death take drastic, or even desperate measures in order to prolong their lives. Such actions often include taking unapproved, investigational drugs. In the U.S., a program known as Compassionate Use, or Expanded Access, allows terminally ill patients who meet certain medical criteria to apply (through their physicians) to the Food and Drug Administration (FDA) and the drug manufacturers for access to drugs that are undergoing FDA clinical trials. At first blush, it may appear that there should be no legal, political, or ethical controversies surrounding the concept of expanded access. How can one possibly deny a dying patient even the slightest chance of prolonged life or recovery? Is there a side effect worse than certain death? Beneath its seemingly altruistic and uncontroversial veneer, the Compassionate Use program has been a lightning rod for intense legal, legislative, and public policy controversies, many of which have been framed as “libertarian vs. regulatory” battles between those who wish to allow patients freer, even unrestricted, access to experimental drugs (often by changing or limiting the role of the FDA), and those who prefer a more measured, rigorous approach to dispensing unproven and potentially dangerous therapies. One of the most highly publicized manifestations of this controversy has been the passage of Right-To-Try Laws in 33 U.S. states (as well as current bills before the U.S. House of Representatives and Senate), which seek to expedite patient accessibility to experimental drugs by allowing patients to appeal solely to drug manufacturers for access to their experimental therapies, thereby eliminating the FDA from the Compassionate Use application process. Vice President Mike Pence recently voiced his support for the national legislation, telling supporters in a closed-door meeting that “he and President Trump have had multiple conversations about this and it’s something the president is very passionate about.” Passion aside, removing the FDA from the Expanded Access equation will in no way result in more patients receiving access to experimental drugs, because it is each drug manufacturer, and not the FDA, that possesses the ultimate authority to dispense its product, and Right-To-Try laws place no requirements on pharmaceutical companies to grant pre-approval access to their investigational therapies. Statistical evidence of how often companies fulfill compassionate use requests is not public knowledge, because drug companies are not required to submit data on appeals they receive, nor their outcomes. There is no published evidence on whether Right-To-Try laws have actually resulted in more patients applying for, or receiving, experimental drugs. The legal status of state Right-To-Try Laws is under scrutiny although, to date, no action has been taken against them by the FDA or other federal authority. Opponents assert that state Right-To-Try Laws are unconstitutional because they are preempted by the FDA’s exclusive federal authority over drug regulation. Proponents of the state laws contend that constitutionally, individual states may provide additional and greater protections of individual rights—including medical rights—often citing the example of Right-to-Die legislation, which falls under state jurisdiction. This debate will be rendered moot if federal Right-To-Try legislation currently before the House and Senate passes, thereby amending the federal jurisdiction of the FDA over Compassionate Use requests. It is unclear whether patients and physicians within the 33 states with Right-To-Try laws have availed themselves of the laws and disregarded the FDA in their Compassionate Use requests. As one recent article notes, “to date, there is no evidence that anyone in a state with a Right-To-Try law has obtained anything under tha[...]

Reaching Beyond Delivery System Walls To Improve Colorectal Cancer Screening

Fri, 24 Mar 2017 14:53:02 +0000

Payers are increasingly using value-based payment to push delivery systems to redefine their product and place. Much has been written about what the new “product” should be, from a hospital stay plus 30 days post-admission, to all the care required by an enrolled or attributed population for a year. Less has been written about the changing place of health care delivery. Delivery systems are designed to care for people who walk through their doors. However, many value-based payment arrangements hold delivery systems accountable for achieving population health goals, such as cancer screening. These goals can best be met by engaging people who may never enter a medical office. For most delivery systems, engaging people before they become patients involves a new skill set. In this post, we describe how one large delivery system—Kaiser Permanente—learned to reach beyond its walls to engage healthy members in colorectal cancer (CRC) screening. The organization shifted from an opportunistic screening program that depended on patients entering its physical premises to a proactive program that leveraged opportunities to communicate with and screen members in their homes. These efforts have dramatically improved CRC screening rates, resulting in reduced incidence of colorectal cancer. This experience is relevant for other delivery systems under value-based payment arrangements, which provide financial flexibility to focus on care that happens outside of the traditional “place” of service delivery. Why Is Colorectal Cancer Screening So Important And Effective? In the United States, colorectal cancer (CRC) is the third-most common cancer and second leading cause of cancer-related death. More than 49,000 people died of the disease in 2016. Although CRC is highly treatable if caught early, only about two-thirds of Americans aged 50-75 receive the recommended screening. Screening rates among certain populations, particularly Latinos and low-income individuals, are even lower. The National Colorectal Cancer Roundtable set a goal of increasing CRC screening rates in the U.S. to 80 percent by 2018. Such an improvement would prevent 277,000 new cancers and 203,000 CRC deaths by 2030. There is clear evidence that three types of CRC screening—colonoscopy, flexible sigmoidoscopy, and fecal occult blood testing (FOBT)—reduce cancer incidence and mortality. These screenings are highly effective because the cancer is slow-growing, and the tests are designed to find both early cancer and pre-cancerous growths called polyps. Polyps can be removed before they turn into cancers. The most commonly used CRC screening test in the U.S. is colonoscopy, with FOBT a distant second, and flexible sigmoidoscopy third. Colonoscopy and flexible sigmoidoscopy can be burdensome for patients because they are invasive, unpleasant, and require an in-office procedure that interrupts normal activities. These tests also require specialized equipment, dedicated space in a health care facility, and significant health care manpower. In contrast, FOBT is a noninvasive test that patients can perform in their own homes and can be easily processed by health care systems. Though doctors—particularly gastroenterologists—may be more likely to offer colonoscopy than other types of tests, research suggests higher uptake of testing when patients are offered either FOBT or a choice among methods. In 2002, Medicare began covering colonoscopy for CRC screening, and in 2010, the Affordable Care Act required private health plans to cover CRC screening tests with no patient cost-sharing. With financial barriers removed, it is up to health systems and insurers to encourage patients to get tested. However, most health systems are not set up to do this, as they rely on opportunistic screening, offering tes[...]