Health and Disability

Vertebroplasty is a safe and effective procedure to reduce acute pain and disability in patients who have experienced spinalfractures within a 6-week period, according to a new study published in The Lancet. In this procedure, a special cement is injected in the fractured vertebra to stabilize the fracture and relieve patients of pressure.

The study also found patients' hospital stays reduced by 5.5 days with vertebroplasty.

The study, coming out of Australia, "Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicenter, randomised, blinded, placebo-controlled trial," considered 120 patients. Sixty-one patients were randomly assigned to vertebroplasty and 59 to a placebo procedure. Only patients with severe pain of 7 or higher on a numeric rating scale (NRS) of 10 were enrolled.

After 14 days of treatment, 23 percent of patients in the vertebroplasty group reported an NRS pain of lower than 4. While 53 percent of patients in the placebo group still had moderate or severe pain six months after the procedure, patients in the vertebroplasty group reported lower pain at all time intervals after the procedure.

Almost 1.4 million patients in the world suffer fractures caused by osteoporosis. While many experience mild symptoms, a portion of them develop considerable pain and disability and require hospital admission.

Vertebroplasty could help them manage their pain and lead to reduced hospital stays, which would lead to overall health care savings. In addition, the study also found the procedure does not contribute to future fractures as was, at times, previously thought.

Without a doubt the biggest health policy/politics story of last week was Aetna’s announced pullout from a large number of ACA markets. Predictably, the announcement was greeted with pronouncements of doom for the ACA. You might think that people who have been predicting disaster since 2010 and have been wrong every time would be a little more circumspect by now. Silly you.

Let's separate the reality from the political spin. A number of factors are contributing to the related phenomena of premium rate increases and carrier market exit. First, the marketplace risk pool is smaller, older and sicker than many analysts anticipated – not always for bad reasons. For example, fewer employers are dropping coverage than CBO expected, making the universe of people eligible for marketplace plans smaller. Other factors driving utilization in the marketplace plans include pent-up demand from the previously uninsured, the extension of certain non ACA-compliant plans that has kept what is likely to be a healthier population out of the ACA marketplace, and the gradual phase-in of the individual mandate, which has probably led some people to decide that going uninsured is still a better deal economically. Congressional efforts to undermine the ACA's risk stabilization programs have not helped either. And two of those programs are expiring in the next year, leading to a one-time premium bump.

In the case of Aetna, there are carrier-specific factors at work, as well. In particular, there seems to be a link between the prospects for Aetna's merger with Humana and its decision to pull out of the marketplaces. In a July letter to the Department of Justice (DOJ), Aetna warned if the merger was blocked, it would pull back on its marketplace participation. The announcement of the pullback came shortly after DOJ sued to block the merger. If you are a complete cynic, you would see this move as either retribution or, at best, a negotiating ploy. It's probably closer to the truth to say the company expected to make a lot of money from the merger and needed some regulatory goodwill to pull it off. In the absence of that goodwill, and with the merger now in doubt, they became less willing to sustain losses in the ACA market.

An understanding of the underlying dynamics leads to the conclusion that some of the factors that are causing the current turbulence will simply abate over time, even if no action is taken. 

Nelson said one of the theories about sundowning is that it is tied to disruptions that often occur in the biological clocks of older people, where their sleep-wake cycles are fragmented.

To test this theory, the researchers also treated the aged mice with melatonin for four weeks in order to help consolidate their circadian rhythms. However, this treatment did not work to reduce anxiety issues in the mice.

Nelson said melatonin alone may not work because it doesn’t deal with the disruptions in the cholinergic system that was identified in this study.

“We need to study whether treating cholinergic dysfunction alone or in combination with melatonin treatment will help deal with sundowning symptoms,” he said.

Under the federal Nursing Home Reform Law, the Centers for Medicare & Medicaid Services (CMS) has authority and the “responsibility”[1] to impose Civil Money Penalties (CMPs) and other enforcement actions at nursing homes that are found to violate federal standards of care (which are called Requirements of Participation).[2]  For the first time in more than 20 years – since the federal enforcement regulations were published in 1994[3] – CMS has increased the numbers and types of situations when CMPs must be imposed against facilities, without first giving the facilities an opportunity to correct their noncompliance.

Effective for all nursing home surveys completed on or after September 1, 2016, CMS’s new national policy mandates, under additional specified circumstances, the immediate imposition of CMPs at nursing homes.[4]  The new policy will be implemented through revisions to Chapter 7 of the State Operations Manual (SOM), Pub. 100-07.[5]

The most striking changes are requirements that CMS impose immediate CMPs when a facility is cited with:

(1) A harm-level deficiency (level G or above)[6] in three specified areas:

• 42 C.F.R. §483.13, Resident Behavior and Facility Practices [restraints],
• 42 C.F.R. §483.15, Quality of Life, or
• 42 C.F.R. §483.25, Quality of Care, and

(2) A harm-level deficiency in any other regulatory requirement on a previous survey, whether the prior survey was an annual survey, a Life Safety Code survey, or a complaint survey. 

These revisions to the so-called “double G” policy, which currently limits the immediate imposition of CMPs to facilities that were cited with G-level deficiencies in two consecutive annual surveys,[7] are significant, especially when viewed historically.

Aetna’s August 15 announcement that is reducing its marketplace participation from 778 to 242 counties has further focused attention on the need to stabilize marketplace risk pools. The Centers for Medicare and Medicaid Services (CMS) have already taken a number of steps toward this end this year, such as tightening up special enrollment periods, improving data matching procedures, and proposing regulatory changes to discourage the sale of short-term or fixed indemnity policies, which siphon off healthy individuals from ACA-compliant comprehensive coverage.

On August 18, CMS took a further step, addressing a concern expressed by insurers that providers and provider-affiliated organizations are steering people eligible for Medicare and/or Medicaid coverage to individual marketplace plans to obtain higher provider payment rates. CMS issued a “request for information,” asking for comments on the extent and nature of this practice and on what can or should be done about it. CMS also sent letters to all Medicare-enrolled dialysis facilities expressing the concerns found in the information request.

CMS is concerned that health care providers are nonetheless steering individuals eligible for Medicare or Medicaid coverage to individual market coverage by paying their premiums or waiving cost-sharing. The payment rates offered by private plans are allegedly sufficiently higher than Medicare or Medicaid rates that providers can cover enrollees premiums and waive cost-sharing obligations and still do better than they could relying on Medicare or Medicaid payment. Insurers believe, however, that the effect of this behavior is to introduce very high-cost enrollees into the individual market risk pool, raising claims costs for insurers and ultimately premium rates for other enrollees. Indeed, United sued a dialysis provider in federal court in early July challenging this practice.

Caregivers were required to clock-in and clock-out of a web-based software platform by ClearCare that operates for visit scheduling, integrated telephony for point-of-care reporting, two-way caregiver messaging and other managerial functions. The check-in moments, which were designated at the beginning and end of a shift for payroll purposes also included a checklist about their patients.

The checklist was administered when caregivers clocked out telephonically, which required them to answer a number of questions devised by the study authors, ClearCare and RAH in 2014. The checklist asked a number of questions, such as, ”Does the client seem different than usual? Has there been a change in mobility, eating or drinking, toileting, skin condition or increase in swelling?”

If a caregiver notes any changes in condition, they receive additional questions before receiving a task on the system dashboard of the office’s care manager. The care manager can use that task, along with more information from the caregiver, to determine potential actions for the patient.

“Most interviewees suggested that changes in condition would not have been reported without the in-home checklist,” the study reads. “They also reported relatively few ‘false positives’ in that they felt that most of the tasks warranted attention.”

An interesting idea about controlling lupus, one of the toughest autoimmune disorders....

Pathological inflammation, a major cause of illness and death around the world, is a hallmark of autoimmune diseases, including lupus and diabetes, as well as chronic conditions such as heart disease and some cancers. It also fuels the organ failure associated with severe infectious diseases such as Ebola or even flu.

Current therapies to treat pathological inflammation generally focus on quieting the overactive immune response, but in suppressing the immune system, patients are vulnerable to severe infections arising from other sources.

Intrigued by the ability of certain polymers to mop up DNA and RNA for gene transfer, Sullenger and colleagues tested the idea that these chemical compounds might also be effective targeting such nucleic acids as they arise in cell death.

"Essentially what you have in an autoimmune disease is a vicious cycle," said lead author Eda K. Holl, Ph.D., assistant professor in Duke's Department of Surgery. "Our goal was to break this cycle at its onset. What we saw in animals with lupus when we used these compounds was a dramatic reduction in inflammation, which gave the body a chance to heal."

Sullenger and Holl said the approach was further tested to see if it compromised the mice's ability to fight outside infections. When they exposed the treated mice to the influenza virus, the animals recovered from the illness even better than healthy mice infected with flu that had not undergone the treatment.

"This approach has the potential to treat a wide range of inflammatory conditions - from lupus to diabetes to even obesity," Sullenger said.

The newly insured people filled, on average, 28 percent more prescriptions and had 29 percent less out-of-pocket spending per prescription in 2014 compared to 2013. Those gaining Medicaid coverage had larger increases in prescription fill rates (79 percent) and reductions in out-of-pocket spending per prescription (58 percent) than those who gained private insurance (with 28 percent more fills and 29 percent less out-of-pocket spending per fill). The study, by Andrew W. Mulcahy, Christine Eibner, and Kenneth Finegold, identified individuals with five chronic condition categories: diabetes, hormone therapy for breast cancer, depression or anxiety, asthma or chronic obstructive pulmonary disease (COPD), and high cholesterol or triglycerides.

Not all those who wander are lost.

Recently, I posted a provocative argument for considering locked doors as physical restraints.  I have received many comments about the post; and as promised, I am following up with a second installment (of three), in which I will give some guidelines for those who wish to take up the challenge.

So, as I mentioned in Part 1, it is best to start by imagining that people’s perambulations are not random but purposeful, even if that purpose is not immediately obvious to us. Let’s also drop the “wandering” and “exit-seeking” terminology, so as not to overmedicalize people’s actions. This is not simply a “BPSD” (Behavioral and Psychotic Symptoms of Dementia). When you see the person instead of the disease, you can see agency instead of confusion.

Second, keep in mind that every one of us walks every day, whenever and wherever we wish. So walking—inside and outside—is normal behavior. It can certainly relate to a person’s distress or indicate an unmet need, but often it is merely an expression of that which the rest of us take for granted.

Let’s start with the structural design, which is easiest to visualize and is also a very important factor. And as I often do, let’s employ The Eden Alternative Domains of Well-Being™ as a framework. In my adaptation of this model, I use the following ordering of the seven domains: identity, connectedness, security, autonomy, meaning, growth, and joy. If these are truly universal human needs, then we can look to see how well the built environment succeeds in these areas.

People desire comfort and familiarity (identity, connectedness). When living with changing cognition, they particularly need an environment that is not overly stressful or challenging to navigate (security, autonomy). The environment also needs to support their continuing sense of purpose, ability to engage and evolve as a person, and desire to be happy and content (meaning, growth, joy). In many ways, most long-term living environments fall short.

Imagine if we considered locked doors in memory care wards as restraints.

Having given many seminars on restraint reduction 15-20 years ago, I am very familiar with how CMS defines a restraint. It’s any device, attached to or adjacent to a person’s body that prohibits freedom of movement.

So obviously a Posey vest fits the definition. But also a low chair from which a person cannot rise independently is also a restraint, even when not tied. The bottom line is that if you could move freely by yourself otherwise, and now you cannot, you are being restrained.