March 10th, 2014
Editor’s note: This post is published in conjunction with the March issue of Health Affairs, which features a cluster of articles on jails and health.
Prison and jail health care, despite occasional pockets of inspiration, provided by programs affiliated with academic institutions, is an arena of endless ethical conflict in which health care providers must negotiate relentlessly with prison officials to provide necessary and decent care. The “right to health care” articulated by the Supreme Court pre-ordained these ongoing tensions. The court reasoned that to place persons in prison or jail, where they could not secure their own care, and then to fail to provide that care, could result in precisely the pain and suffering prohibited by the Eighth Amendment to the Constitution.
Good reasoning was followed by a deeply flawed articulation of the “right” that defines the medical care entitlement as care provided to inmates without “deliberate indifference to their serious medical needs.” By forging a standard which was, and remains, unique in medicine and health care delivery — designed to avoid intruding on state malpractice litigation regarding adequacy of practice and standards of care — the court guaranteed that dispute would surround delivery. That first framing, which did not establish a right to “standard of care” or to care delivered according to a “community standard,” set the stage for endless ethical and legal conflict.
The Eighth Amendment’s deliberate indifference standard, forbidding cruel and unusual punishment, presents a relatively demanding standard for proving liability. The Eighth Amendment, as interpreted by the federal courts, does not render prison officials or staff liable in federal cases for malpractice or accidents, nor does it resolve inter-professional disputes — or patient-professional disputes — about the best choice of treatment. It does require, however, that sufficient resources be made available to implement three basic rights: the right to access to care, the right to care that is ordered, and the right to a professional medical judgment. Read the rest of this entry »
March 10th, 2014
On March 7, 2014, the Centers for Medicare and Medicaid Services of the Department of Health and Human Services released its final rule on the Basic Health Program (BHP). This rule finalizes a rule proposed by CMS in September of 2013, which was covered here. CMS also released its methodology for funding the BHP for 2015. Finally, CMS published, along with the Departments of Labor and Treasury, a request for information regarding the implementation of a provision of the Affordable Care Act that prohibits insurers from discriminating against providers based on their licensure or certification status.
This post will discuss these issuances, as well as a decision by the United States Court of Appeals for the District of Columbia rejecting yet one more challenge to the ACA. Read the rest of this entry »
March 10th, 2014
Editor’s Note: This post is the fifth in 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.
Alongside the challenge of improving insurance coverage for palliative care, caregivers and practitioners face a continuing challenge in mobilizing long-term services and supports (LTSS), that is, personal assistance to those unable to perform basic tasks of daily living. These services are an essential part of palliative care. Whatever a patient’s wishes, unless LTSS are available to support patients and caregivers at home, the emergency department and the hospital become the only option when a symptom or caregiver exhaustion crisis occurs.
But identifying, accessing and coordinating long-term care services are not easy. Further, financing to support these services is beyond the scope of standard insurance. Few people have private long-term care insurance, and Medicare’s coverage of nursing homes and home health is contingent on the need for skilled nursing or therapy care. MedPac reports that in 2011, Medicare-covered nursing home stays averaged only about 27 days and home health aide (personal care) visits averaged only about five per home health user. Although a recent legal settlement has required CMS to clarify that coverage is not contingent on evidence of patient improvement, the skilled care requirement remains intact. Read the rest of this entry »
March 8th, 2014
Editor’s note: Part 1 of this post discussed the Department of Health and Human Services March 5 bulletin extending until October 1, 2016 its transitional policy permitting the renewal of ACA non-compliant individual and small group health insurance policies. Part 1 also began examining the final 2015 Notice of Benefit and Payment Parameters rule, issued on the same date; that analysis was concluded in Part 2. Part 3 below discusses two final rules also issued March 5 by the Internal Revenue Service regarding reporting by insurers of minimum essential coverage and reporting by employers on coverage under employer-sponsored health plans.
On March 5, 2014, the Internal Revenue Service released two final rules governing two of the Affordable Care Act’s most important reporting rules. One rule implements section 6055 of the Internal Revenue Code, which requires health insurers, self-insured employers, and other entities that provide minimum essential insurance coverage to individuals to report to the IRS information about the type and period of coverage and to provide statements containing this information to covered individuals.
The other rule implements section 6056 of the IRC, which requires large employers (generally employers with at least 50 full-time or full-time equivalent employees) to report to the IRS information concerning the health care coverage that they provide their employees to demonstrate compliance with the employer responsibility provisions of the ACA, and to provide statements to their employees regarding available employer-sponsored coverage so that the employees may determine whether they may claim premium tax credits under the ACA.
These reporting requirements were supposed to be implemented for the 2014 reporting year, but the administration decided last summer to delay the reporting requirements, and with them the employer mandate, because of difficulties with implementing the reporting requirements. The rules are now final and are effective for reports to be filed in 2016 for reporting year 2015. Read the rest of this entry »
March 7th, 2014
Editor’s note: Part 1 of this post discussed the Department of Health and Human Services March 5 bulletin extending until October 1, 2016 its transitional policy permitting the renewal of ACA non-compliant individual and small group health insurance policies. Part 1 also began examining the final 2015 Notice of Benefit and Payment Parameters rule, issued on the same date; that analysis is concluded below. Part 3 will discuss two final rules also issued March 5 by the Internal Revenue Service regarding reporting by insurers of minimum essential coverage and reporting by employers on coverage under employer-sponsored health plans.
Reduced notice requirement for new state exchanges. The final 2015 Benefit and Payment Parameters rule requires states that would like to begin operating their own exchanges to notify HHS of this intention by June 15 of the preceding year. Earlier rules had required a year’s notice.
Consumer assistance and privacy. States may permit web brokers to assist individuals, employers, and employees with enrolling in qualified health plans (QHPs) through their exchanges. Agents and brokers must comply with privacy and security standards protecting personally identifiable information and may not use it for marketing. The SHOP exchange, and not the web broker, is responsible for aggregating premiums and forwarding them to insurers. Web brokers must display information on all available QHPs, although insurers may refuse to provide non-appointed brokers with certain information. Web brokers must also provide enrollees with a disclaimer noting that they are not the exchange and may not have full information on all plans.
State exchanges must comply with federal personally identifiable information requirements, but may seek the approval of HHS to use this information to ensure the efficient operation of the exchange if they secure the consent of the individual whose information is to be used. Exchanges that disclose personally identifiable information to non-exchange entities (such as certified application counselors, in-person assisters, brokers, QHP insurers or others) must enter into a contract with these entities ensuring protection of this information. Non-exchange entities that must independently comply with Health Insurance Portability and Accountability Act data privacy and security requirements (such as QHPs) may be deemed to be in compliance with exchange requirements by virtue of their compliance with HIPAA as long as the HIPAA requirements are at least as protective as the exchange requirement and if the entities also comply with additional ACA data protection requirements. Read the rest of this entry »
March 7th, 2014
Quality improvement (QI) and patient safety initiatives are created with the laudable goal of saving lives and reducing “preventable harms” to patients. As the number of QI interventions continues to rise, and as hospitals become increasingly subject to financial pressures and penalties for hospital-acquired conditions (HACs), we believe it is important to consider the impact of the pressure to improve everything at once on hospitals and their staff.
We argue that a strategy that capitalizes on “small wins” is most effective. This approach allows for the creation of steady momentum by first convincing workers they can improve, and then picking some easily obtainable objectives to provide evidence of improvement.
National Quality Improvement Initiatives
Our qualitative team is participating in two large ongoing national quality improvement initiatives, funded by the Agency for Healthcare Research and Quality (AHRQ). Each initiative targets a single HAC and its reduction in participating hospitals. We have visited hospital sites across six states in order to understand why QI initiatives achieve their goals in some settings but not others. To date, we have conducted over 150 interviews with hospital workers ranging from frontline staff in operating rooms and intensive care units to hospital administrators and executive leadership. In interviews for this ethnographic research, one of our interviewees warned us about unrealistic expectations for change: “You cannot go from imperfect to perfect. It’s a slow process.”
While there is much to learn about how to achieve sustainable QI in the environment of patient care, one thing is certain from the growing wisdom of ethnographic studies of QI: buy-in from frontline providers is essential for creating meaningful change. Frontline providers often bristle at expectations from those they believe have little understanding of the demands of their daily work. Requiring health care providers to improve on all mandated measures at once, in an atmosphere of reduced reimbursements and frequent staff shortages, is a goal that risks burnout, discouragement, and apathy — all signs of initiative fatigue. Read the rest of this entry »
March 7th, 2014
Editor’s note: In addition to Jonathan Simon (photo and bio above), this post is coauthored by Daniel Mistak, a graduate student in Jurisprudence and Social Policy at the University of California, Berkeley. He previously earned his juris doctorate from University of California, Berkeley, School of Law. Prior to law school he attained a master’s degree in philosophy, with a focus in bio-ethics, and a master’s degree in genetics and cell biology. This post is published in conjunction with the March issue of Health Affairs, which features a cluster of articles on jails and health.
California’s system of incarceration is in the midst of sweeping changes. Recent shifts in state and federal law, motivated and bolstered by Supreme Court decisions, have created a perfect storm for institutional change. But as with any storm, it can be difficult to predict what can be done to prepare and what will be left when the clouds clear.
What caused this perfect storm in California? In 2011, the Supreme Court found in Brown v. Plata that California’s prisons could not meet the mental and physical health needs of the inmates because of prison overcrowding. To avoid violating the VIII Amendment’s prohibition on cruel and unusual punishment, the Court mandated that California prisons decrease their over-crowded prison populations to 137.5 percent of their design capacity within two years. Governor Jerry Brown signed into law Assembly Bill 109 (‘Realignment’) to facilitate this transition. Read the rest of this entry »
March 7th, 2014
March 5, 2014 was a banner day for Affordable Care Act implementation. The Department of Health and Human Services released its final 2015 Notice of Benefit and Payment Parameters rule (fact sheet here), as well as a bulletin extending until October 1, 2016 its transitional policy permitting the renewal of ACA non-compliant individual and small group health insurance policies. The Internal Revenue Service also issued two final rules regarding reporting by insurers of minimum essential coverage and reporting by employers on coverage under employer-sponsored health plans. (Fact sheet here.)
This post will discuss the HHS bulletin and begin consideration of the benefit and payment parameter rule. Subsequent posts will discuss the remainder of the benefit and payment parameters rule and the IRS rules.
HHS Bulletin On ACA Non-Compliant Policies
On November 14, 2013, the Center for Medicare and Medicaid Services issued a letter to state insurance commissioners informing them that CMS would permit state regulators to allow insurers to renew non-grandfathered health insurance policies in the individual and small group market that did not comply with the 2014 market reform rules for policy years beginning by October 1, 2014. Specifically, renewed 2013 plans did not need to comply with the guaranteed issue and guaranteed renewability requirements; limitations on health status underwriting and preexisting condition exclusions (for adults); the single risk-pool requirement; the prohibition against discrimination; the essential health benefit and clinical trial coverage requirements; and limitations on cost-sharing. (Group plans are not excluded from the preexisting condition and discrimination provisions.) Insurance departments in 27 states allowed insurers to renew 2013 policies, while 21 states and the District of Columbia prohibited renewals.
The March 5, 2014 bulletin permits states and insurers to extend this transitional relief for another two years, that is, for policies renewed prior to October 1, 2016. It also allows states to permit employers with 51 to 100 employees, which are currently considered large employers but will become small employers as of January 1, 2016, to renew their current policies through October 1, 2016. States that had not earlier decided to implement the transitional policy may still do so for 2013 policies renewing in 2014. States may also opt to implement the transitional policy for fewer than two years, or only in the individual or in the small-group market, or only for large employers that become small employers. Read the rest of this entry »
March 6th, 2014
It’s worth sitting up and taking notice when everyone seems to hate what you are doing. Last week, 20 of the 24 members of the sometimes fractious Senate Finance Committee wrote Centers for Medicare and Medicaid Services Administrator Marilyn Tavenner about a Medicare Part D proposed rule CMS published on January 10. They told her that they were “perplexed as to why CMS would propose to fundamentally restructure Part D …” and urged her to scrap the plan.
The House Energy and Commerce Committee held a hearing, also last week, with the hardly neutral title of “Messing with Success: How CMS’ Attack on the Part D Program Will Increase Costs and Reduce Choices for Seniors.” At the hearing, Medicare Chief Jon Blum, one of the most well-liked federal health officials there is, was subjected to a bipartisan, first class, grilling.
These Congressional complaints followed on the heels of a Feb. 28 letter slamming the proposed rule from 277 organizations (with more organizations continuing to sign on) including patient advocates, insurance companies, health plans, pharmacists, employers, and both brand and generic drug companies.
In fairness to CMS, this is only a proposed rule and comment is what they are seeking. Well, it is comment that they are getting. What has led to this firestorm of criticism? Read the rest of this entry »
March 6th, 2014
There exist scientifically promising treatments not being tested further because of insufficient financial incentives. Many of these therapies involve off-label uses of drugs approved by the Food and Drug Administration that are readily available and often inexpensive. Pharmaceutical companies—largely responsible for clinical drug development—cannot justify investing in such clinical trials because they cannot recoup the costs of these studies. However, without prospective data demonstrating efficacy, such treatments will never be adopted as standard of care.
In an era of increasing health care costs and the need for effective therapies in many diseases, it is essential that society finds ways to adopt these “financial orphans.” We propose several potential solutions for the non-profit sector, pharmaceutical companies, health insurers, patient driven research, and others to accomplish this goal.
Drug Development Today
Under today’s drug development model, the vast majority of clinical trials are sponsored by pharmaceutical companies, and the process is lengthy, expensive, and, some have argued, inefficient. The cost of developing a new FDA-approved drug is estimated to exceed $1.2 billion, the average time from lead to market is typically over 10 years, and only 1 in 10 drugs entering a phase I study is finally approved. Thus pharmaceutical companies, seeking to recoup this investment, conduct a return on investment (ROI) calculation with attention to both scientific and financial considerations such as the chances of success and whether the therapy will be sufficiently profitable to justify the high cost of clinical development.
These considerations sometimes lead to inefficient outcomes from society’s perspective in which promising and potentially transformative therapies are not pursued because of improperly designed financial incentives. We call such therapies “financial orphans.” Read the rest of this entry »