In Senate Health Care Bill, A Few Hidden Surprises

https://goo.gl/XxMZtY

A low-income person, eligible for Medicaid but not enrolled, is hit by a car or a bullet. Gravely injured, she arrives at the hospital unconscious. Thanks to expert, intensive care that lasts for days or weeks, she gradually recovers. Eventually, her health improves to the point where she can complete the paperwork needed to apply for Medicaid.

Such a hospital can be paid today, thanks to Medicaid’s “retroactive eligibility.” Even if the combination of medical problems and bureaucratic delays prevents an application from being filed and completed for several months, Medicaid will cover the care if the patient was eligible when services were provided.

The newest version of the Senate health bill—the Better Care and Reconciliation Act, or BCRA—would end this longstanding feature of the Medicaid program for beneficiaries who are neither elderly nor people with disabilities. If services are received in one calendar month and the application is completed the following month, the hospital would be denied all payment, even if the patient was eligible and the services were both essential and costly.

It does not matter if the state is led by a governor who understands the devastating impact of this change on hospital infrastructure, especially in rural areas where many hospitals are hanging on by a thread. Today, states have the flexibility to seek waivers that limit retroactive eligibility. Under the BCRA, that flexibility would disappear, as states are forced to end retroactive coverage, whether they like it or not.

Almost certainly, this provision would come as a surprise to most senators who are being asked to support the BCRA. It is only one of many unpleasant surprises lurking largely undiscovered throughout the bill. Following are other selected examples.


More People Are Making Mistakes With Medicines At Home

https://goo.gl/d6wyfc

When people take medicine at home, mistakes happen.

Some people end up taking the wrong dose of a medication or the wrong pill. Sometimes, they don't wait long enough before taking a second dose.

Other times, it's a health professional who's at fault. A pharmacist might have dispensed a medication at the wrong concentration, for example.

These kinds of mistakes are on the rise, according to a study published Monday in the journal Clinical Toxicology.

The researchers looked at a small subset of the medication errors that happen in the U.S. every year. The FDA estimates that about 1.3 million people are injured by medication errors annually in the U.S.

The study analyzed data collected by poison control centers across the U.S. and counted only errors that happened outside health care facilities and resulted in serious medical outcomes. That's defined in the study as symptoms that typically require some treatment to life-threatening situations and even death.

They found that the number of these cases doubled, from 3,065 cases in 2000 to 6,855 cases in 2012. In the 13 years covered by the study, more than 67,000 such errors occurred, and 414 people died as a result. Most of the mistakes were preventable, the study finds.

"We know that a third of the cases in this study resulted in hospital admissions, so these aren't minor errors. These can be pretty significant," says Nichole Hodges, a research scientist at Nationwide Children's Hospital in Columbus, Ohio, and the study's lead author. She says errors at home represent a significant public health burden and are likely undercounted.

"Since we're only including those non-health care facility errors that are reported to poison control centers, it's an underestimate of the true number," she says.

Jay Schauben, a former president of the American Association of Poison Control Centers, points out that not everyone calls a poison control center when they experience one of these events. And he says there could be "minor inaccuracies" in the data from poison control, because the employees who answer calls are relying on what the caller tells them, and if a physician calls about a patient, that physician might not know exactly what happened to the patient.

Despite these limitations, he says the study's findings are still valid and useful. And he says he's glad to see this study draw attention to medication errors happening at home.

"We focus on medication errors in health care facilities, and we tend to forget that these types of errors do occur in the home scenario and potentially go uncorrected, maybe unrecognized," Schauben says.



F.D.A. Panel Recommends Approval for Gene-Altering Leukemia Treatment

https://goo.gl/3yMUoH

A Food and Drug Administration panel opened a new era in medicine on Wednesday, unanimously recommending that the agency approve the first-ever treatment that genetically alters a patient’s own cells to fight cancer, transforming them into what scientists call “a living drug” that powerfully bolsters the immune system to shut down the disease.

If the F.D.A. accepts the recommendation, which is likely, the treatment will be the first gene therapy ever to reach the market. Others are expected: Researchers and drug companies have been engaged in intense competition for decades to reach this milestone. Novartis is now poised to be the first. Its treatment is for a type of leukemia, and it is working on similar types of treatments in hundreds of patients for another form of the disease, as well as multiple myeloma and an aggressive brain tumor.

To use the technique, a separate treatment must be created for each patient — their cells removed at an approved medical center, frozen, shipped to a Novartis plant for thawing and processing, frozen again and shipped back to the treatment center.

A single dose of the resulting product has brought long remissions, and possibly cures, to scores of patients in studies who were facing death because every other treatment had failed. The panel recommended approving the treatment for B-cell acute lymphoblastic leukemia that has resisted treatment, or relapsed, in children and young adults aged 3 to 25.


Type 1 diabetes risk linked to intestinal viruses

https://goo.gl/rWxNc8

Now, a new study led by Washington University School of Medicine in St. Louis has found that viruses in the intestines may affect a person’s chance of developing the disease. Children whose gut viral communities, or viromes, are less diverse are more likely to generate self-destructive antibodies that can lead to Type 1 diabetes. Further, children who carried a specific virus belonging to the Circoviridaefamily were less likely to head down the path toward diabetes than those who carried members of a different group of viruses.

“We identified one virus that was significantly associated with reduced risk, and another group of viruses that was associated with increased risk of developing antibodies against the children’s own cells,” said Herbert “Skip” Virgin IV, MD, PhD, the Edward Mallinckrodt Professor and head of Pathology and Immunology, and the study’s senior author. “It looks like the balance of these two groups of viruses may control the risk of developing the antibodies that can lead to Type 1 diabetes.”

The findings, published online the week of July 10 in Proceedings of the National Academy of Sciences, suggest a way to predict, and maybe even prevent, the life-altering diagnosis.


Research Offers Hope For NF2 Neuro-Tumor Patients

I worked with a number of people with NF in the 70's.....

https://goo.gl/PP3bi4

Since all NF2 patients develop multiple schwannomas, the scientists have developed a human cell culture model for schwannoma, comprising of human schwannoma cells isolated from both patients and control normal healthy Schwann cells (which form the sheath that protects nerves). Using this model, the research team found for the first time that PrPC is over-produced in schwannoma compared with healthy Schwann cells. This overproduction is due to Merlin deficiency and strongly contributes to tumour growth and patient prognosis.

The research team have already identified a range of existing drugs which could manage this protein overproduction and that are used currently for other non-NF2-related conditions, such as Creutzfeldt-Jakob disease, multiple myeloma (a type of bone marrow cancer) and Acute Myeloid Leukaemia (AML). By repurposing existing drugs, an effective therapy could be made available to NF2 patients, based on the failure of Merlin tumour suppressor expression, relatively quickly. The safety testing process for human use has already taken place for the original purpose of these drugs, which means they could be fast-tracked into clinical studies for NF2.

Disparities in Diabetes and Hypertension Care for Individuals With Serious Mental Illness

https://goo.gl/X32pkx

Objectives. People with serious mental illnesses (SMI), including schizophrenia, bipolar disorder, and major depression, experience early mortality, partly due to comorbid physical health conditions such as diabetes and hypertension. This study examined the quality of diabetes and hypertension care for Medicaid and Medicare enrollees with SMI.

Results. Adults with SMI receive poor-quality care for diabetes and hypertension. Depending on the health plan, performance on the diabetes care and hypertension control HEDIS measures was 14 to 49 percentage points lower among the SMI population than the general Medicaid and Medicare populations. 

Conclusions. Findings highlight disparities in care for individuals with SMI compared with the general Medicaid and Medicare populations. Health plans demonstrated substantial room for improvement on almost all diabetes and hypertension HEDIS measures for the SMI population.


Multiple Recurring C. Diff Infections on the Rise: Researchers aren't sure why

Really? They aren't sure why?.....
https://goo.gl/5f9Svf

In an analysis of a large, nationwide health insurance database, researcher's at the University of Pennsylvania's Perelman School of Medicine found that the annual incidence of multiple recurring Clostridium difficile (mrCDI) increased by almost 200% from 2001 to 2012. During the same period the incidence of ordinary CDI increased by only about 40%. The study results were published this week in the Annals of Internal Medicine.

The reasons for the sharp rise in mrCDI incidence is unknown. Researchers said the finding points to an increased burden on the healthcare system, including increased demand for new treatments for recurrent CDI. The most promising of these new treatments, fecal microbiota transplantation -- the infusion of beneficial intestinal bacteria into patients to compete with C. difficile -- has shown good results in small studies, but hasn't yet been thoroughly evaluated. 

(It hasn't been thoroughly evaluated because pharma makes more money from expensive antibiotics than from fecal transplants.)


FDA approves new treatment for sickle cell disease

L-glutamine is a naturally sweet tasting precursor to some important neurotransmitters that has been used since the 70's for a wide variety of brain-based symptoms because the precursor can cross the blood-brain barrier. The most common that I saw was for inability to fall asleep because of churning thoughts. Its effectiveness in sickle cell is very important as you can read in the article since it is only the second one available (Gee, I wonder why there isn't more research on Sickle Cell?).....

https://goo.gl/jRP2x7

The U.S. Food and Drug Administration today approved Endari (L-glutamine oral powder) for patients age five years and older with sickle cell disease to reduce severe complications associated with the blood disorder.

"Endari is the first treatment approved for patients with sickle cell disease in almost 20 years," said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence. "Until now, only one other drug was approved for patients living with this serious, debilitating condition."

Sickle cell disease is an inherited blood disorder in which the red blood cells are abnormally shaped (in a crescent, or "sickle," shape). This restricts the flow in blood vessels and limits oxygen delivery to the body’s tissues, leading to severe pain and organ damage. According to the National Institutes of Health, approximately 100,000 people in the United States have sickle cell disease. The disease occurs most often in African-Americans, Latinos and other minority groups. The average life expectancy for patients with sickle cell disease in the United States is approximately 40 to 60 years.

The safety and efficacy of Endari were studied in a randomized trial of patients ages five to 58 years old with sickle cell disease who had two or more painful crises within the 12 months prior to enrollment in the trial. Patients were assigned randomly to treatment with Endari or placebo, and the effect of treatment was evaluated over 48 weeks. Patients who were treated with Endari experienced fewer hospital visits for pain treated with a parenterally administered narcotic or ketorolac (sickle cell crises), on average, compared to patients who received a placebo (median 3 vs. median 4), fewer hospitalizations for sickle cell pain (median 2 vs. median 3), and fewer days in the hospital (median 6.5 days vs. median 11 days).  Patients who received Endari also had fewer occurrences of acute chest syndrome (a life-threatening complication of sickle cell disease) compared with patients who received a placebo (8.6 percent vs. 23.1 percent).

Common side effects of Endari include constipation, nausea, headache, abdominal pain, cough, pain in the extremities, back pain and chest pain.

Endari received Orphan Drug designation for this use, which provides incentives to assist and encourage the development of drugs for rare diseases.  In addition, development of this drug was in part supported by the FDA Orphan Products Grants Program, which provides grants for clinical studies on safety and/or effectiveness of products for use in rare diseases or conditions.

10 Questions: Elizabeth Madigan, PhD, RN

https://goo.gl/NXio4G

1. What's the biggest barrier to practicing medicine today?

In the U.S., we still have a system that makes care coordination difficult. Almost everyone has a story about an older friend or relative who sees multiple providers, but, for example, there is no communication between that patient's cardiologist and rheumatologist. The electronic health record has helped [when] the providers are in the same healthcare system. Across healthcare systems, we are not there yet.

I come from the home healthcare world. In that setting, we routinely may be unable to access electronic healthcare information for all the systems through which a patient receives care. As a result, home healthcare nurses cannot easily and seamlessly share their observations with other providers. We're making progress on this front, and I am optimistic that this barrier will be greatly reduced in the next five years.

2. What's the most important healthcare issue that nobody is talking about?

The aging of the healthcare provider workforce. Throughout the nursing community, we are well aware of the growing nursing shortage. For nurses, but also physicians, physical therapists, and other disciplines, the retirement projections are scary. With the aging of the American population and the growth in chronic non-communicable diseases, we will need more providers than we have now. There are not enough younger people entering these professions to replace the retiring members. This is not just an American issue; many other countries have the same concerns, Japan being one of them.


Rural/Urban Disparity in Cancer Mortality

https://goo.gl/tAoxEu

Rural Americans develop cancer less often than their metropolitan counterparts but are more likely to die of the disease, according to a first-of-its-kind report from the CDC.

From 2006 to 2015, cancer mortality in rural areas decreased by 1% a year as compared with a 1.6% annual decline in urban areas. The percentages translated into cancer-associated death rates of 180 per 100,000 persons in rural areas versus 158 per 100,000 in urban areas.

Rural areas had a lower cancer incidence over the 10-year period that ended in 2013, 442 cases versus 457 cases per 100,000 in urban areas. Overall, cancer incidence decreased about 1% per year in rural and metropolitan areas, as reported in Morbidity and Mortality Weekly Report.

"Differences between nonmetropolitan and metropolitan counties in cancer incidence might reflect differences in risk factors such as cigarette smoking, obesity, and physical inactivity, whereas differences in cancer death rates might reflect disparities in access to healthcare and timely diagnosis and treatment," S. Jane Henley, PhD, of the CDC National Center for Chronic Disease Prevention and Health Promotion, and coauthors concluded.