Saliva Test Predicts Prolonged Concussion Symptoms in Children

According to the American Academy of Pediatrics, although the majority of concussions that are diagnosed annually occur in children, clinical guidelines are usually based on adult concussion sufferers. The lack of guidelines may limit the ability of pediatricians to accurately predict the duration of a child’s symptoms, including headaches, fatigue, and concentration problems — which can interfere with school and other activities.

In many concussion cases, concussion symptoms last only a few days. However, up to 25 percent of children have prolonged concussion symptoms which can last for months.

Concussion Symptom Saliva Test Study Presented at Annual Meeting

New research presented at the 2017 Pediatric Academic Societies (PAS) Meeting suggests that a saliva test for children may offer answers as to how long concussion symptoms will last. Researchers presented an abstract of the study, “Peripheral microRNA patterns predict prolonged concussion symptoms in pediatric patients.” The PAS Meeting is produced through a partnership of four organizations: Academic Pediatric Association, American Academy of Pediatrics, American Pediatric Society, and Society for Pediatric Research.

Results of Concussion Symptom Saliva Test Study

Following a concussion, injured brain cells release fragments of genetic material (microRNAs) which show up in blood and saliva. Studies have found altered micro ribonucleic acids (miRNA) levels in the saliva of children with mild concussions. Similar miRNA changes have been found in cerebrospinal fluid of patients with severe brain injury.

Researchers at Penn State College of Medicine studied 50 children, ages 7 to 18 years old who experienced mild traumatic brain injury. Spit samples from each child were tested for miRNA levels. Concussion symptoms were evaluated through the parent and child Sports Concussion Assessment Tool (SCAT-3) surveys.

Researchers found that salivary miRNA levels were more effective than SCAT-3 surveys in predicting which children would continue to experience concussion symptoms that lasted longer than four weeks. The SCAT-3 surveys were less than 70 percent accurate in identifying children who would have prolonged concussion symptoms. The miRNA saliva test correctly predicted whether concussion symptoms would last for at least a month nearly 90 percent of the time.

The saliva-based RNA testing indicates the potential for an accurate and non-invasive method to evaluate pediatric concussions and provide a more accurate prognosis.

This post was written by Bruce H. Stern of STARK & STARK., COPYRIGHT © 2017
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Mild Traumatic Brain Injury and the Pupillary Light Reflex

According to a recent review study of Pubmed Central/National Library of Medicine databases, the pupillary light reflex provides an optimal opportunity to investigate mild traumatic brain injury (mTBI).

Based on the findings of the review, the pupillary system may provide a noninvasive “window” to mTBI, in terms of documenting its existence and the often-accompanying symptom of photosensitivity. When an individual experiences mTBI, visual dysfunction may occur, and the pupillary light reflex may be affected. Pupils are routinely assessed for abnormal size and responsivity to determine the neural integrity of the visual system. Investigating pupillary light reflex in the mTBI population, researchers found that pupillary response was significantly delayed, slowed, and reduced, symmetrically, with a smaller baseline diameter. These findings may indicate dysfunction of the pupillary pathway.

Several objective biomarkers for the presence of mTBI and photosensitivity provide further insight into neurological dysfunction. In mTBI, photosensitivity may be due to dysfunction in the baseline neural sensor. Photosensitivity as a perceptual phenomenon can be confirmed through objective, noninvasive, rapid, vision-based, pupillary biomarkers.

Pupillary light reflex in mTBI may be investigated with pupillometers to assess subtle abnormalities in pupil size as well as pupillary responses. The resulting information can provide diagnostic or prognostic indicators relating to the extent of the injury, and neurophysiological linkages. Pupillometers offer precise and extensive pupillary testing for the mTBI population, especially those individuals who experience photosensitivity. The major drawback is cost. Development of a more inexpensive hand-held pupillometer would help with diagnosis of mTBI and improve patient care.

With such instrumentation, pupillary light reflex could be used to investigate the possibility of a very early, acute-stage mTBI/concussion in emergency rooms, in the workplace, and even on the sideline of sports games. Such information can be relevant to a worker’s compensation determinations, social security disability determinations, and return-to-play/work/learn standards for both adults and children.

This post was written by Bruce H. Stern of STARK & STARK., COPYRIGHT © 2017
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Elder Abuse: Are Granny Cams a Solution, a Compliance Burden, or Both?

In Minnesota, 97% of the 25,226 allegations of elder abuse (neglect, physical abuse, unexplained serious injuries and thefts) in state-licensed senior facilities in 2016 were never investigated. This prompted Minnesota Governor, Mark Dayton, to announce plans last week to form a task force to find out why. As one might expect, Minnesota is not alone. A studypublished in 2011 found that an estimated 260,000 (1 in 13) older adults in New York had been victims of one form of abuse or another during a 12-month period between 2008 and 2009, with “a dramatic gap” between elder abuse events reported and the number of cases referred to formal elder abuse services. Clearly, states are struggling to protect a vulnerable and growing group of residents from abuse. Technologies such as hidden cameras may help to address the problem, but their use raises privacy, security, compliance, and other concerns.

With governmental agencies apparently lacking the resources to identify, investigate, and respond to mounting cases of elder abuse in the long-term care services industry, and the number of persons in need of long-term care services on the rise, this problem is likely to get worse before it gets better. According to a 2016 CDC report concerning users of long-term care services, more than 9 million people in the United States receive regulated long-term care services. These numbers are only expected to increase. The Family Caregiver Alliance reports that

by 2050, the number of individuals using paid long-term care services in any setting (e.g., at home, residential care such as assisted living, or skilled nursing facilities) will likely double from the 13 million using services in 2000, to 27 million people.

However, technologies such as hidden cameras are making it easier for families and others to step in and help protect their loved ones. In fact, some states are implementing measures to leverage these technologies to help address the problem of elder abuse. For example, New Jersey’s Attorney General recently expanded the “Safe Care Cam” program which lends cameras and memory cards to Garden State residents who suspect their loved ones may be victims of abuse by an in-home caregiver.

Common known as “granny cams,” these easy-to-hide devices which can record video and sometimes audio are being strategically placed in nursing homes, long-term care, and residential care facilities. For example, the “Charge Cam” (pictured above) is designed to look like and actually function as a plug used to charge smartphone devices. Once plugged in, it is able to record eight hours of video and sound. For a nursing home resident’s family concerned about the treatment of the resident, use of a “Charge Cam” or similar device could be a very helpful way of getting answers to their suspicions of abuse. However, for the unsuspecting nursing home or other residential or long-term care facility, as well as for the well-meaning family members, the use of these devices can pose a number of issues and potential risks. Here are just some questions that should be considered:

  • Is there a state law that specifically addresses “granny cams”? Note that at least five states (Illinois, New Mexico, Oklahoma, Texas, and Washington) have laws specifically addressing the use of cameras in this context. In Illinois, for example, the resident and the resident’s roommate must consent to the camera, and notice must be posted outside the resident’s room to alert those entering the room about the recording.
  • Is consent required from all of the parties to conversations that are recorded by the device?
  • Do the HIPAA privacy and security regulations apply to the video and audio recordings that contain individually identifiable health information of the resident or other residents whose information is captured in the video or audio recorded?
  • How do the features of the device, such as camera placement and zoom capabilities, affect the analysis of the issues raised above?
  • How can the validity of a recording be confirmed?
  • What effects will there be on employee recruiting and employee retention?
  • If the organization permits the device to be installed, what rights and obligations does it have with respect to the scope, content, security, preservation, and other aspects of the recording?

Just as body cameras for police are viewed by some as a way to help address concerns over police brutality allegations, some believe granny cams can serve as a deterrent to abuse of residents at long-term care and similar facilities. However, families and facilities have to consider these technologies carefully.

This post was written by Joseph J. Lazzarotti  of Jackson Lewis P.C. © 2017
For more legal analysis, go to The National Law Review 

FDA Issues Final Regulations Easing the Path for Direct-to-Consumer Genetic Testing

New regulations issued on November 7, 2017 by FDA will make it easier for companies to offer certain types of genetic tests directly-to-consumers, without a health-care provider intermediary.

The first regulation finalizes a new medical device classification for “autosomal recessive carrier screening gene mutation detection systems.”  This regulation essentially codifies classification already established by FDA in response to a request by 23andMe, and  enables other laboratories to offer their DTC tests according to the criteria specified in the classification regulation.  These tests may be offered without the need for FDA premarket review.

Similarly, the second regulation finalizes a new medical device classification for  DTC “genetic health risk assessment” (GHR)  (i.e., predictive) tests.  The classification specifies the conditions under which these tests may be marketed, and includes the requirement for a 510(k) premarket notification to FDA. However, in a Federal Register Notice, also issued yesterday, FDA proposes to exempt GHR tests from the 510(k) premarket submission requirement after a lab has successfully obtained FDA clearance of its first GHR assay.  Comments to this proposed exemption are being accepted by FDA until January 8. 

This post was written by Gail H. Javitt of Epstein Becker & Green, P.C. All rights reserved., ©2017
For more Health Care legal analysis, go to The National Law Review

Telemedicine – Are There Increased Risks With Virtual Doctor Visits?

“Telemedicine” or “Telehealth” are the terms most often used when referring to clinical diagnosis and monitoring that is delivered by technology. Telemedicine encompasses healthcare provided via real time two-way video conferencing; file sharing, including transmission of health history, x-rays, films, or photos; remote patient monitoring; and consumer mobile health apps on smart phones, tablets, and devices that collect data and transmit it to a healthcare provider. Telemedicine is increasingly being used for everything from diagnosing common viruses to monitoring patients with serious long-term health issues.

The American Telemedicine Association reports that majority of hospitals now use some form of telemedicine. Two years ago, there were approximately 20 million telemedicine video consultations; that number is expected to increase to about 160 million by 2020. An estimated one-third of employer group plans already cover some type of telehealth.

Telemedicine implicates legal and regulatory issues as licensing, prescribing, credentialing, and cybersecurity. Pennsylvania recently passed legislation joining the Interstate Medical Licensing Compact, an agreement whereby licensed physicians can qualify to practice medicine across state lines within the Compact if they meet the eligibility requirements. The Compact enables physicians to obtain licenses to practice in multiple states, while strengthening public protection through the sharing of investigative and disciplinary information.

Federal and state laws and regulations may differ in their definitions and regulation of telemedicine. New Jersey recently passed legislation authorizing health care providers to engage in telemedicine and telehealth. The law establishes telemedicine practice standards, requirements for health care providers, and telehealth coverage requirements for various types of health insurance plans. Earlier this year, Texas became the last state to abolish the requirement that patient-physician relationships must first be established during an in-person patient/doctor visit before a telemedicine visit.

As telemedicine use increases, there will likely be an increase in related professional liability claims. One legal issue that arises in the context of telemedicine involves the standard of care that applies. The New Jersey statute states that the doctor is held to the same standard of care as applies to in-person settings. If that is not possible, the health care provider is required direct the patient to seek in-person care. However, the standard of care for telemedicine is neither clear nor uniform across the states.

Another issue that arises in the context of telemedicine is informed consent, especially in terms of communication, and keeping in mind that the Pennsylvania Supreme Court recently held that only the doctor, and not staff members, can obtain informed consent from patients. Miscommunication between a healthcare provider and patient is often an underlying cause of medical malpractice allegations in terms of whether informed consent was obtained.

In addition, equipment deficiencies or malfunctions can mask symptoms that would be evident during an in-person examination or result in the failure to transmit data accurately or timely, affecting the diagnosis or treatment of the patient.

Some of these issues will likely ultimately be addressed by legislative or regulatory bodies but others may end up in the courts. According to one medical malpractice insurer, claims relating to telemedicine have resulted from situations involving the remote reading of x-rays and fetal monitor strips by physicians, attempts to diagnose a patient via telemedicine, delays in treatment, and failure to order medication.

recent Pennsylvania case illustrates how telemedicine may also impact the way medical malpractice claims are treated in the courts. In Pennsylvania, a medical malpractice lawsuit must be filed in the county where the alleged malpractice occurred. Transferring venue back to Philadelphia County, the Superior Court in Pennsylvania found that alleged medical malpractice occurred in Philadelphia — where the physician and staff failed to timely transmit the physician’s interpretation of an infant’s echocardiogram to the hospital in another county where the infant was being treated.

The use of telemedicine will likely have wide-reaching implications for health care and health care law, including medical malpractice.

This post was written by Michael C. Ksiazek of STARK & STARK, COPYRIGHT ©
2017
For more Health Care legal analysis, go to The National Law Review 

Trump Administration Limits Affordable Care Act’s Contraceptive Coverage Mandate

On Friday October 6, 2017, the Trump administration released two interim final rules expanding the exemptions allowed under the Patient Protection and Affordable Care Act’s (the “ACA’s”) contraceptive coverage mandate. Under the ACA, employer group health plans generally are required to cover contraceptives, sterilization, and related patient education and counseling, with exemptions provided for religious houses of worship. The exemption was expanded by the Department of Health and Human Services (HHS) as a result of the Supreme Court’s decision in Burwell v. Hobby Lobby 34 S. Ct. 2751 (2014), which held health plans of closely held for-profit corporations are not required to cover contraceptives if doing so would contradict the owner’s religious beliefs under the Religious Freedom Restoration Act.

The interim final rules, released by the Treasury Department, Department of Labor (DOL), and HHS, are effective immediately and provide exemptions from the contraceptive coverage mandate to many employers with “sincerely held religious beliefs” or “sincerely held moral convictions”. The interim final rules limit the exemption for “sincerely held moral convictions” to houses of worship, tax-exempt entities, and closely held for-profit corporations, but permit publicly traded for-profit entities to use the exemption for “sincerely held religious beliefs.” According to the Trump administration, the United States has had a long history of providing protections in the regulation of health care for individuals and entities with objections based on religious beliefs or moral convictions. To take advantage of the new exemption, eligible employers must notify employees that they will no longer provide contraceptive coverage but need not inform the federal government. The Employee Retirement Income Security Act of 1974, as amended (ERISA) requires that a Summary of Material Modification (SMM) is provided within 60 days of a “material reduction” in covered services or benefits provided under a group health plan. A material reduction includes the elimination of benefits payable under a group health plan. According to an Obama administration report released last year, 55 million women have gained access to no-cost birth control as a result of the contraceptive coverage mandate. It is not clear how many entities may claim the exemptions, but HHS has predicted about 200 entities (affecting 120,000 women) may do so based on the number of entities that filed lawsuits.  Written comments on the interim final rules are due December 5, 2017.

This post was written by Cassandra Labbees of Epstein Becker & Green, P.C. All rights reserved., ©2017
For more legal analysis go to The National Law Review

Effects of Insurance Marketplace Uncertainty

Even as Senators continue to consider “Graham-Cassidy,” the latest Affordable Care Act (ACA) repeal legislation, insurance markets are already reacting to uncertainty and instability brought about by persistent GOP efforts to upend the post-ACA insurance landscape. Between the Trump Administration’s ongoing refusal to commit to long-term funding of the ACA’s cost-sharing reductions (CSRs) and legislative overtures to repeal key portions of the ACA, premiums have increased, insurers have exited state exchanges, and access to health care coverage has been compromised.

As the Congressional Budget Office (CBO) recently estimated, insurers are expected to “raise premiums for marketplace plans in 2018 by an average of roughly 15 percent, largely because of uncertainty about whether the federal government will continue to fund CSR payments and because of an increase in the percentage of the population living in areas with only one insurer.” Speaking to the latter factor, CBO notes that a number of insurers have withdrawn from healthcare exchanges established under the ACA, spurred, at least in part, by “uncertainty about the enforcement of the individual mandate, and uncertainty about the federal government’s future payments for [CSRs].” Although ACA proponents’ (and critics’) most dire predictions were narrowly avoided – that some counties would have no insurers offering marketplace plans – there is little doubt that insurer participation has been adversely impacted by market uncertainty, with pocketbook repercussions for policy-holders.

The turbulent political climate is also likely to reduce the number of insured individuals in 2018. CBO and the Joint Committee on Taxation anticipate lower insurance enrollment as a result of reductions in federal-sponsored advertising and outreach. Department of Health and Human Services officials recently indicated that the advertising budget for the open enrollment period commencing in November would be reduced to $10 million, amounting to a 90% reduction when compared to spending in the last year of the Obama Administration. Grants to “navigators” – nonprofit groups that assist people with marketplace insurance plan enrollment – will be reduced from approximately $63 million to $36 million.

Whether or not the worst is yet to come will hinge on the fate of Graham-Cassidy and the presently-stalled efforts to reach consensus on a bipartisan ACA stabilization bill. In what is turning out to be a recurring theme in 2017, we may have to wait several weeks for the dust to settle and reasoned prognostication to be possible.

This post was written by Matthew J. Goldman & Jordan E. Grushkin of Sheppard Mullin Richter & Hampton LLP., Copyright © 2017
For more legal analysis go to The National Law Review