November 25th, 2014
During the last decade, workplace wellness programs have become commonplace in corporate America. The majority of US employers with 50 or more employees now offer the programs. A 2010 meta-analysis that was favorable to workplace wellness programs, published in Health Affairs, provided support for their uptake. This meta-analysis, plus a well-publicized “success” story from Safeway, coalesced into the so-called Safeway Amendment in the Affordable Care Act (ACA). That provision allows employers to tie a substantial and increasing share of employee insurance premiums to health status/behaviors, and subsidizes such program implementation by smaller employers. The assumption was that improved employee health would reduce the employer burden of health care costs.
Subsequently, however, Safeway’s story has been discredited. And the lead author of the 2010 meta-analysis, Harvard School of Public Health Professor Katherine Baicker, has cautioned on several occasions that more research is needed to draw any definitive conclusions. Now, more than four years into the ACA, we conclude that these programs increase, rather than decrease employer spending on health care with no net health benefit. The programs also cause overutilization of screening and check-ups in generally healthy working age adult populations, put undue stress on employees, and incentivize unhealthy forms of weight-loss.
Through a review of the research literature and primary sources, we have found that wellness programs produce a return-on-investment (ROI) of less than 1-to-1 savings to cost. This blog post will consider the results of two compelling study designs — population-based wellness-sensitive medical event analysis, and randomized controlled trials (RCTs). Then it will look at the popular, although weaker, participant vs. non-participant study design. (It is beyond the scope of this posting to question non-peer-reviewed vendor savings claims that do not use any recognized study design, though those claims are commonplace.) Read the rest of this entry »
November 25th, 2014
This year marks the 15th anniversary of the Institute of Medicine (IOM)’s To Err is Human report, which famously declared that from 44,000 to 98,000 Americans died each year from preventable mistakes in hospitals and another one million were injured. That blunt conclusion from a prestigious medical organization shocked the public and marked the arrival of patient safety as a durable and important public policy issue.
Alas, when it comes to providing the exact date of this medical mistakes milestone, the IOM itself is confused and, in a painful piece of irony, sometimes just plain wrong. That’s unfortunate, because the date of the report’s release is an important part of the story of its continued influence.
There’s no question among those of us who’d long been involved in patient safety that the report’s immediate and powerful impact took health policy insiders by surprise. The data the IOM relied upon, after all, came from studies that appeared years before and then vanished into the background noise of the Hundred Year War over universal health insurance. This time, however, old evidence was carefully rebottled in bright, compelling new soundbites. Read the rest of this entry »
November 24th, 2014
Two earlier posts this past weekend analyzed the massive Department of Health and Human Services 2016 Benefit and Payment Parameter Proposed Rule, released on November 21. Also on November 21, the Internal Revenue Service of the Department of the Treasury released a final rule on Minimum Essential Coverage and Other Rules Regarding the Shared Responsibility Payment for Individuals, while the Office of Personnel Management released proposed modifications to the multi-state plan (MSP) program rule. This post explores these rules.
Minimum Essential Coverage
The ACA requires Americans to either maintain “minimum essential coverage” (MEC) or pay a tax. There are a number of exceptions to the requirement, however, and the concept of MEC can become quite complicated. The final rule published by the IRS provides guidance as to the meaning of MEC and the rules governing some of the exceptions. Read the rest of this entry »
November 23rd, 2014
On November 21, 2014, the Centers on Medicare and Medicaid Services of the Department of Health and Human Services released its proposed Benefits and Payment Parameters (BPP) Rule. Part I of this post examined the benefit provisions of this proposed rule. This post will analyze the parts of the rule that deal with the insurance market reforms; the reinsurance, risk adjustment, and risk corridor programs; health insurance rate review; and the individual and SHOP exchanges.
New Definitions Of ‘Plan’ And ‘State’
The regulation begins with a modified definition of the term “plan.” The terms “plan” is important in the ACA regulations. A plan has been defined, with respect to a health insurer, as the combination of a benefit package, metal tier, and service area. The new definition adds to this combination cost-sharing structure and provider network, so that plans that differ in their cost-sharing structure (deductibles, copayments, or coinsurance) or provider networks are different plans, even if they are offered at the same metal tier. This definition becomes important, for example, in determining whether a plan offered outside the exchange is the same as a qualified health plan (QHP) offered in the exchange and can thus participate in the risk corridor program. The proposed regulations later propose that the unreasonable rate review regulation applies at the plan level. Read the rest of this entry »
November 22nd, 2014
On November 15, 2014, the marketplaces reopened for 2015. Anecdotal reports indicate that in most places enrollment and reenrollment are running smoothly. But the Centers of Medicare and Medicaid Services (CMS) of the Department of Health and Human Services (HHS) is looking forward to 2016. On November 21 CMS published its massive 2016 Notice of Benefit and Payment Parameters (BPP) Proposed Rule with accompanying fact sheet. It also published the draft 2016 actuarial value calculator and draft actuarial value calculator methodology for 2016. Finally, CMS published a guidance on hardship exemptions for certain individuals.
Not to be outdone, the Department of the Treasury, Internal Revenue Service released its final regulation on Minimum Essential Coverage and other Rules Regarding the Shared Responsibility Payment for Individuals, together with a Notice regarding Individual Shared Responsibility Payment Hardship Exemptions that May be Claimed on a Federal Income Tax Return Without Obtaining a Hardship Exemption Certificate from the Marketplace and a Revenue Procedure setting out indexed adjusted percentages of income that will be used for determining the level of contributions expected of individuals before premium tax credits become available, the affordability threshold for the shared responsibility payments unaffordability exemption, and the threshold for determining whether employer coverage is affordable for purposes of determining eligibility for tax credits.
Finally, the Office of Personnel Management released a lengthy proposed rule proposing modifications in the multi-state plan program. These rules, proposed rules, and guidances will be addressed in a series of posts over the next several days. This post will address primarily the consumer-facing provisions of the BPP proposed rule, focusing on changes in benefits. A second post will follow, discussing the provisions of the rule more relevant to insurers, such as proposed changes in the reinsurance, risk adjustment, and risk corridor rules. A final post will discuss the IRS rule, which is primarily a finalization of proposals and guidances already made public, and the OPM multi-state plan rule. Read the rest of this entry »
November 21st, 2014
With the Food and Drug Administration (FDA)’s approval of Harvoni, the successor to Gilead Science’s Sovaldi, the alarm bells have officially rung on breakthrough hepatitis C treatments. One can’t open a newspaper or scan a Twitter feed without stumbling on at least one reference to either of the these two drugs for hepatitis C — an often debilitating viral infection impacting the liver that affects somewhere between 3 to 5 million Americans and several hundred million people worldwide. Hepatitis C infection is often asymptomatic and can have long latency periods. In up to 20 percent of people, chronic infection can lead to liver failure, liver cancer, and potentially liver transplantation.
Gilead Sciences paid $11 billion to acquire the rights to Sovaldi — a drug that offers significant improvement in viral clearance over existing therapies — and launched the drug in the U.S. market at a price ($1,000 per pill, or $84,000 per course of treatment) that is usually reserved for drugs targeting “orphan conditions” for much smaller populations. Not surprisingly, Congress has taken an interest, patient advocacy groups are organizing, the health care community is holding conferences, coalitions are channeling a growing national outrage about the price, and public and private payers are stymied by the challenge of responsibly managing utilization of the drug. Read the rest of this entry »
November 20th, 2014
Evidence mounts that a major disconnect exists between the services most frail older adults need and what they get. The vast majority of frail older adults (around 75 percent) who face challenges in taking care of themselves live at home. According to new research from Vicki Freedman and Brenda Spillman, published in the most recent issue of The Milbank Quarterly, almost a third of these older adults report having an adverse consequence as a result of not getting the help they need. These consequences are pretty grim – the most frequently reported event being wet clothes associated with an unmet need around toileting.
But the most shocking statistic from this research is that hiring a paid helper appears to do little to protect against these consequences. Among those who hired help, nearly 60 percent reported adverse consequences. No doubt this reflects a higher level of need: paid helpers are brought in when the risk is quite high. But, it also reflects an inadequacy in support — an analogous group living in supportive housing (i.e., residential care or assisted living facilities) reported these events at a much lower rate (36 percent). Read the rest of this entry »
November 20th, 2014
Editor’s note: This post is part of a series of several posts stemming from presentations given at “The Law of Medicare and Medicaid at Fifty,” a conference held at Yale Law School on November 6 and 7.
Through much of the last half century, Medicare and Medicaid (MM) have not for the most part supported research intended to lead to new drugs. For their role in drug development, we need to look to infrastructure and incentives. The record of the National Institutes of Health (NIH) illustrates the potential of both for pharmaceutical innovation. The current budget of NIH, the big elephant in the zoo of the federal biomedical enterprise, is $30 billion, but apart from a dozen small programs devoted to targeted drug development, most of these billions are not aimed directly at pharmaceutical innovation (See page 234).
Yet the NIH investment in biomedicine has indirectly fueled drug development in the private sector to a huge degree. It has paid for the training of biomedical scientists and clinicians, many of whom went on to staff the drug industry, especially its laboratories. NIH-sponsored research has also generated basic knowledge and technologies and it has encouraged universities to spin out their potentially useful findings into the industry by allowing for the patenting and licensing of the findings.
Like NIH, MM has helped fuel drug development indirectly by supporting selected experimental cancer treatments, medical education, and some clinical research and training. But investment in these activities has been small and their impact on drug development apparently very limited. In contrast to NIH, the MM stimulus to drug innovation has resided not in the production of new scientists or the patented uses of new knowledge, but principally in markets and pricing. Read the rest of this entry »
November 20th, 2014
Well before the Affordable Care Act was passed in 2010, efforts to expand interprofessional education (IPE) were beginning to change the mindset that permeated much of health professional education in the US. One such example is the Vanderbilt Program in Interprofessional Learning (VPIL) that was established in 2010 with initial support from the Josiah Macy Jr. Foundation, and later from the Baptist Health Trust.
To learn about the challenges, successes, and surprises experienced by those who developed and lead IPE at Vanderbilt, I interviewed Linda Norman, dean of Vanderbilt University School of Nursing, Bonnie Miller, associate vice chancellor for Health Affairs and senior associate dean for Health Sciences Education at Vanderbilt University Medical Center, and Heather Davidson, director of Program Development for VPIL.
Peter Buerhaus: What were the key challenges faced when you started IPE at Vanderbilt?
Read the rest of this entry »
November 19th, 2014
Before the end of the year, the Obama administration is expected to announce that millions of undocumented immigrants will be able to lawfully stay in the United States. The new Congress may also take action on immigration reform legislation. Regardless of how it happens, any immigration policy change presents a good opportunity to revisit what has gone wrong with insurance coverage and health care for millions of immigrants, both undocumented and lawfully present, living and working in communities across the country.
A web of policy barriers to public and private insurance options effectively keeps millions of immigrant women and their families from affordable coverage and the basic health care—including sexual and reproductive health services—that coverage makes possible. Removing these barriers would advance the health and economic well-being of immigrant women, their families, and society as a whole. Most immediately, administrative steps advancing access for even some immigrants would be an important step forward. The case for doing so is compelling. Read the rest of this entry »