LTC BULLETIN BOARD
LTC Bulletin Board - December 2012: Page 2 of 2
LTC Policy News
Medicare Improvement Standard Challenged
On November 20, 2012, a settlement agreement received preliminary approval in the landmark federal class action lawsuit of Jimmo vs Sebelius that, if permanently approved, would relax the requirements for Medicare beneficiaries seeking coverage of skilled nursing and long-term care services. Filed in January 2011, the suit challenges an interpretation of the Improvement Standard that has allowed Medicare to refuse coverage for patients with progressive or chronic diseases, such as Parkinson’s, Alzheimer’s, and stroke, if they do not show demonstrable improvement in their conditions. The case plaintiffs are seeking prohibition of the continued application of the Improvement Standard and a review to determine whether prior denial of coverage based on the standard should be revised. Under the agreement, Medicare would pay for services that are needed “to maintain the patient’s current condition or prevent or slow further deterioration.”
Among the major provisions of the proposed settlement, a nationwide class would be certified consisting of all beneficiaries who received an adverse administrative decision based on the Improvement Standard that became final and non-appealable on or after January 18, 2011. Many of those class members would be entitled to a re-review of their claims. Additionally, the Centers for Medicare & Medicaid Services (CMS) would be required to revise relevant portions of the Medicare Benefit Policy Manual to eliminate any suggestion that a beneficiary must show a potential for improvement, with the need for skilled care being the determinative factor. CMS also has the option of issuing a ruling on the corrected policy. If the settlement is approved, CMS will have 1 year to carry out an educational campaign informing beneficiaries of the change, at the end of which there would be a 2- or 3-year monitoring period to ensure compliance and class members would have the opportunity for re-review of claims. A Fairness Hearing on the proposed settlement is scheduled for January 2013. To stay up to date with this landmark lawsuit, visit www.medicareadvocacy.org/2012/11/01/jimmo-v-sebelius.
Physicians Can Now Monitor Stroke Patients From Afar With TeleStroke
As part of the trend to modernize patient care by using robotics, video conferencing systems, and other technologies, researchers are working toward finding more efficient ways to provide care to stroke patients and bolster resources to understaffed hospitals. According to the Centers for Disease Control and Prevention, an estimated 800,000 Americans experience a stroke every year, and about 130,000 of those cases are fatal. After a patient has an acute stroke, the most critical time for treatment is within 3 to 4 hours, however, prompt evaluation and treatment may be challenging for patients living in rural areas, where hospital emergency rooms may not have the necessary equipment or neurological expertise to treat stroke patients. Bart Demaerschalk, MD, and colleagues at the Mayo Hospital, Phoenix, AZ, have developed an innovate new telemonitoring system called TeleStroke that enables physicians to remotely view patient’s files and vital signs, take and examine radiographs and computed tomography scans, and recommend treatment options to the hospital staff. The TeleStroke system facilitates communication between the physician and the remote hospital staff with a robot that has digital video cameras and an Internet connection. The Mayo Clinic in Arizona has been working with stroke telemedicine since 2007. Their program has since grown to 11 remote sites. To subscribe to the Mayo Clinic’s stroke telemedicine service at your clinic, visit www.mayoclinic.org/stroke-telemedicine.
Managing Fecal Incontinence With a Tissue-Bulking Gel
As patients age, the probability of fecal incontinence increases greatly. Almost 50% of the elders residing in nursing homes experience bouts of fecal incontinence. Some elders are unlikely to report fecal incontinence to their healthcare providers due to embarrassment or believing that it is a normal part of aging. However, the condition can make it difficult to perform activities of daily living and may be indicative of a serious underlying condition, such as poor diet, diarrhea, constipation, or damage to the rectum or rectal walls. Dietary changes and antimotility medications are used to treat the condition, but once these fail, patients may have another treatment option: Solesta, a biocompatible tissue-bulking gel that is injected into the layer of tissue underneath the anus. Approved by the FDA on May 27, 2011 to treat fecal incontinence, the
sterile gel is made of dextranomer and sodium hyaluronate, both naturally made materials. Treatment with Solesta requires a series of four shots to narrow the opening of the anus in an effort to reduce uncontrolled bowel movements.
Solesta was clinically tested in approximately 200 patients across the United States and Europe. Patients were randomly selected to receive either Solesta or a placebo over a period of 6 months. Just over 50% of the patients receiving Solesta saw an improvement in the number of incontinence episodes, compared with about 30% of the patients receiving the placebo. Those on Solesta had a smaller risk of abdominal pain, constipation, diarrhea, and fever. Based on this trial, it was recognized that Solesta can provide symptom relief to some patients, but it is not a cure.
Possible side effects of Solesta include pain or discomfort in the rectum/anus, possible light rectal bleeding after the procedure, and a rare risk of infection or inflammation around the anus. Solesta is contraindicated in persons who have received radiation treatment in the pelvic area, have rectal or anal problems (such as tumors), have an active inflammation of the bowels, have trouble fighting off infections, or have had a device/material already placed in their rectum or anus. For more information about Solesta, visit www.solestainfo.com.
Integrated Wall System Saves Time and Space in Clinical Care Settings
Efficiency and accuracy are key qualities of patient care and clinical decision-making. When time with patients is lost searching for pieces of equipment, untangling cumbersome cords, and digging through files for patient data, it is time to upgrade your system. The Connex Integrated Wall System by Welch Allyn organizes the tools needed for physical assessment and vitals management into one central location. With this all-in-one system, patient data is collected quickly and accurately, allowing the physician to immediately view results and send them directly to an electronic medical records system, reducing the risk of recording errors via manual transcription. The wall system saves valuable floor space and includes a large graphic display touchscreen and four USB ports for users to customize and expand the system features as the need arises. Its features include integrated otoscope and opthalmoscope, ear thermometry, pulse oximetry, blood pressure test, and programmable visual and audible alarms. For a complete list of features and purchasing information for the Connex Integrated Wall System, visit www.welchallyn.com/promotions/connex-evd/connex-iws.
Ask the Expert
Tetrabenazine in the Treatment of Movement Disorders
Nationwide, an estimated 30,000 individuals have Huntington’s chorea, an incurable neurodegenerative disease. There is no known way to stop progression of the disease, thus the goal of treatment is to slow down the symptoms and employ palliative care. In 2008, the FDA approved Xenazine (tetrabenazine), the first medication to treat patients with chorea associated with Huntington’s disease. There has been much research evaluating the efficacy of tetrabenazine in the treatment of other movement disorders as well. Jack Chen, PharmD, and colleagues at the Movement Disorders Clinic, Loma Linda University, Loma Linda, CA, recently published a comprehensive review of the literature on tetrabenazine (Clin Ther. 2012;34:1487-1504.). Annals of Long-Term Care® (ALTC) had the opportunity to interview Dr. Chen about the risks and benefits of tetrabenazine in the treatment of Huntington’s chorea and other movement disorders.
ALTC: You recently reviewed the medical literature on tetrabenazine. Can you briefly summarize your findings?
Dr. Chen: Tetrabenazine was FDA-approved based on efficacy and safety data for chorea associated with Huntington’s disease, but tetrabenazine is also useful for a variety of other hyperkinetic movement disorders that are also considered “rare” or “orphan” diseases. Examples include tardive dyskinesia, dystonias, and tic disorders. The symptoms and functional outcomes of these movement disorders can be very distressing to patients and a challenge for clinicians to treat. My coauthors and I wrote the article to help clinicians better understand the role and use of tetrabenazine, not only in Huntington’s chorea, but also in these other movement disorders.
Tetrabenazine has been used worldwide for decades, but it was only approved in the United States as a treatment for Huntington’s chorea in August 2008. Why do you think it took so long for the FDA to approve it?
Prior to FDA approval, physicians were able to prescribe tetrabenazine and patients were able to purchase and import the drug from other countries provided they had a prescription for an approved Investigational New Drug. For example, the Movement Disorders program at Baylor College of Medicine accumulated and published much of the outcomes data for tetrabenazine in various hyperkinetic movement disorders.
Basically, there are many conditions (eg, Huntington’s disease, Tourette syndrome), which affect such small numbers of individuals residing in the United States that these conditions are considered rare here, and adequate drugs for many of these conditions have not been developed. Drugs for these conditions are commonly referred to as “orphan drugs.” Since so few individuals are affected by any one rare condition, a pharmaceutical company that develops an orphan drug may reasonably expect the drug to generate relatively small sales in comparison to the cost of developing the drug and consequently to incur a financial loss. With the Congressional passage in 1983 of the Orphan Drug Act, changes in federal laws provided incentives for pharmaceutical companies to develop promising orphan drugs. Tetrabenazine is an example of an orphan drug that was FDA-approved as a result of the Orphan Drug Act.
Can you briefly explain tetrabenazine’s mechanism of action?
The primary pharmacological action of tetrabenazine is to inhibit the human vesicular monoamine transporter 2 (VMAT2). Inhibition of VMAT2 prevents translocation of neurotransmitter monoamines (eg, dopamine, norepinephrine, serotonin) from the cytoplasm into synaptic vesicles; therefore, the monoamines are exposed to premature degradation and cannot be stored for synaptic release. Pharmacological reduction of monoamines in brain regions, such as the striatum, is believed to contribute to attenuation of hyperkinetic movements. The drug also has metabolites that possess similar pharmacologic activity.
Tetrabenazine can be used for multiple movement disorders; in your review of the literature, did you find that one disorder responded better to tetrabenazine than others?
Tetrabenazine should be considered a first agent to treat chorea of Huntington’s disease.
Are there any major side effects in patients using tetrabenazine? If so, were they common among all patients or specific to age, sex, or dosage?
Common side effects include somnolence, depression, and Parkinsonism. These side effects are dose-related and can be managed by dose reduction. Elderly patients may be at greater risk for experiencing tetrabenazine-induced Parkinsonism, and patients with a history of depression are at greater risk of tetrabenazine-induced depression.
How do outcomes and quality of life of patients taking tetrabenazine compare with those of patients who do not take treatment for their involuntary movement disorders?
Tetrabenazine can improve functional outcomes, particularly for those with severe involuntary movements, and with improvement of functional outcomes, quality of life is also improved. Many of these involuntary movements can also be stigmatizing to patients, and improvement of symptoms can enhance personal and social well-being.