Author: WorkCompAcademy

In medicine, compliance describes the degree to which a patient correctly follows medical advice. Most commonly, it refers to medication or drug compliance, but it can also apply to other situations such as medical device use, self care, self-directed exercises, or therapy sessions.

Poor compliance with drug regimens is a common problem in many disease areas, especially when patients suffer from chronic conditions. In particular, low rates of adherence to therapies for asthma, diabetes, and hypertension are thought to contribute substantially to the human and economic burden of those conditions. Estimates from the World Health Organization indicate that only about 50% of patients with chronic diseases living in developed countries follow treatment recommendations.

But new technology may help improve compliance statistics. The FDA has approved the first digital pill with an embedded sensor to track if patients are taking their medication properly, marking a significant step forward in the convergence of healthcare and technology.

The medicine is a version of Otsuka Pharmaceutical Co Ltd’s established drug Abilify for schizophrenia, bipolar disorder and depression, containing a tracking device developed by California based Proteus Digital Health.

The system offers doctors an objective way to measure if patients are swallowing their pills on schedule, opening up a new avenue for monitoring medicine compliance that could be applied in other therapeutic areas.

The system works by sending a message from the pill’s sensor to a wearable patch, which then transmits the information to a mobile application so that patients can track the ingestion of the medication on their smartphone. The underlying technology is Proteus Discover which is comprised of ingestible sensors, a small wearable sensor patch, an application on a mobile device and a provider portal.

About the size of a grain of salt, the sensor has no battery or antenna and is activated when it gets wet from stomach juices. That completes a circuit between coatings of copper and magnesium on either side, generating a tiny electric charge.

In the longer term, such digital pills could also be used to manage patients with other complicated medicine routines, such as those suffering from diabetes or heart conditions.

Proteus has been working on the pill tracking system for many years and the sensor used in Abilify MyCite was first cleared for use by the FDA in 2012.

The California company has attracted investments from several large healthcare companies, including Novartis AG, Medtronic Inc and St. Jude Medical Inc, as well as Otsuka.

In workers’ compensation claims, it is not uncommon for claim administrators to encounter claimants who assert that they are profoundly disabled from the effects of what seems like a trivial injury. A minor hand injury can end up a multi-body part claim of disability basically from head to toe.

But not everyone succumbs to the effects of injury, even a catastrophic injury. The events of this Veteran’s day weekend offered a good example.

Ask Rob Jones. He braved the cold weather on Veterans Day to complete his mission: running 31 marathons in 31 days. This challenge was after losing both his legs to an improvised explosive device in Afghanistan in 2010, Jones has shown endurance that few can rival and certainly would not be seen by many as “disabled.”

“I’m pretty sore, but overall I am feeling pretty good,” Jones told Stars and Stripes as the sun rose over the Lincoln Memorial. Jones’ final run was on the National Mall in Washington, where he ran 26.2 miles to support his fellow veterans and raise money for charity.

Jones was laid out on a couch before setting out for his final run shortly after 7 a.m., bandages being taken of his back after falling during a race in Atlanta. He sat up, his artificial legs off, and clearly thought about this last race while he spoke.

Jones began his quest Oct. 12 in London, then flew to the States to race in Philadelphia, New York and Boston. He has raced in nearly every major city since then, running the equivalent of a marathon each day.

There was an air of exhaustion and pain about him, but he seemed determined. “I’m feeling good. I’m excited about this last one. It is going to be painful,” he said.

Or ask Brian Shul. He flew 212 combat missions in Vietnam and was shot down near the Cambodian border in an AT-28 Air Force jet near the end of the war. He was so badly burned that he was given next to no chance to live.

Barely surviving 2 months of intensive care, he was flown to the Institute of Surgical Research at Fort Sam Houston, Texas in 1974. During the following year, he underwent 15 major operations. During this time he was told by physicians that he’d never fly again and was lucky to be alive.

Months of physical therapy followed, enabling Shul to eventually pass a flight physical and return to active flight duty. Two days after being released from the hospital, Shul was back flying Air Force fighter jet aircraft. He flew the the A10, A7 and the F5. As a final assignment in his career, Shul volunteered for and was selected to fly the SR-71. This assignment required an astronaut type physical just to qualify, and Shul passed with no waivers.

Shul said after the rigorous physical “I did very well, passed the physical. The guy said, ‘wow, you’ve got one of the highest scores we’ve ever seen.’ I was very strong internally, even if I looked like hell on the outside.” He became a member of a small, select group of men who had the privilege of flying the SR-71.

He ended up flying the SR-71 Blackbird for four years. The SR-71 was the world’s fastest and highest-flying operational manned aircraft throughout its career. It broke an “absolute altitude record” of 85,069 feet. That same day it set an absolute speed record of 2,193.2 mph approximately Mach 3.3. It has flown from Los Angeles to Washington, D.C., at an average speed 2,144.8 miles per hour with an elapsed time of 64 minutes 20 seconds to cross the continent.

Shul’s comeback story from lying near dead in the jungle of Southeast Asia, to later flying the world’s fastest, highest flying jet, seems to suggest that the will to overcome “disability” is a major component to the healing process after what would otherwise be a catastrophic injury.

He spoke at the Lawrence Livermore National Laboratory last December, and this  YouTube video of his return to the flight line is humorous, inspiring, and perhaps a way to see a much different outcome to having had a so called “catastrophic Injury.”

Shul just refused to see himself as disabled, despite what dozens of doctors had to say about his prospects of recovery.

Chronic pain affects up to 20% of people in developed countries, and represents not only a profound impact on individuals and their families but also a sizeable burden on employers, health care systems, and society in general.

Management of chronic pain varies greatly between nations and even within nations. Literature supports a multidisciplinary approach as the standard of care, although various health care systems may not always support this concept consistently.

A new study published in the Journal of Pain Research evaluates another safe and effective drug-free treatment option for chronic pain sufferers — spinal cord stimulation (SCS).

Spinal cord stimulation, also known as dorsal column stimulation, uses low-voltage electrical stimulation to the spine to block the feeling of pain, via a small device implanted in the body. The field of neuromodulation for the treatment of pain has developed rapidly since the seminal paper on the electrical inhibition of pain by the stimulation of the dorsal column almost 50 years ago. (Shealy CN, Mortimer JT, Reswick JB. Electrical inhibition of pain by stimulation of the dorsal columns: preliminary clinical report. Anesth Analg. 1967;46(4):489-491)

Patients typically undergo a trial of neuromodulation with an externalized power source and if this trial proves to be positive and compelling, they subsequently have a subcutaneously implantable pulse generator for the long-term therapy.

Spinal cord stimulation technologies are fast advancing, and an update of the literature was much needed. The newest study, authored by an Australian team, looks at recent evidence for safety, efficacy and cost-effectiveness of spinal cord stimulation in back and limb pain.

In recent years, the next phase in the evolution of neuromodulation has become available with the development of dorsal root ganglion (DRG) SCS and the emerging use of two novel advances in stimulation frequencies, being high-frequency SCS (at 10,000 Hz) and burst SCS.14-19 These recent advances have improved the efficacy and expanded the applicability of SCS.

The authors reviewed the scientific evidence from three studies looking at the different routes of spinal cord stimulation: dorsal root ganglion SCS, burst wave form SCS and high frequency 10 (HF10) SCS. They found that the literature supports the use of traditional SCS for chronic pain, and provides high-quality evidence that dorsal root ganglion SCS and HF10 SCS are safe and effective for back and leg chronic pain.

Lead author Paul Verrills from the Metro Pain Group in Melbourne, Australia, thinks the study findings represent “unheralded evidence that we can safely treat back and leg pain using spinal cord stimulation techniques.” Most importantly, spinal cord stimulation has relatively few side effects compared to other chronic pain therapies, and reduces the risks of complications.

Verrills goes on to say, “Spinal cord stimulation should now be considered earlier in the treatment continuum and not simply as an end-stage salvage therapy.”

In May 2011, Sim Carlisle Hoffman M.D. was indicted on 884 felony counts alleging healthcare insurance fraud in violation of section 550. Hoffman was the owner of Advanced Professional Imaging (API), Advanced Management Services (AMS), and Better Sleeping Medical Center (BSMC) in Buena Park, and prosecutors accused him of running a “medical mill” for the sole purpose of insurance over-billing without providing any legitimate treatment to patients.

Orange County District Attorney Tony Rackauckas and California Insurance Commissioner Dave Jones originally announced the hundreds and hundreds of charges against Hoffman, BSMC neurologist Dr. Michael Heric of Malibu, Hoffman’s administrator Beverly Mitchell of Westlake Village and API billing collector Louis Santillan of Chino Hills.

The 2011 indictment was ultimately dismissed in 2013 on the ground that the prosecution had failed to provide exculpatory evidence to the grand jury.

Rather than proceed by indictment, in January 2014, the prosecutors filed a felony complaint against Hoffman. The complaint alleged 159 counts of insurance fraud. One year and one-half later – after four amendments and two demurrers – the people filed a fifth amended complaint, alleging violations of section 550, subdivision (a)(5) (33 counts), subdivision (a)(6) (135 counts), and subdivision (a)(7) (one count).

The preliminary hearing began on September 1, 2015, and ended on November 23 of that year. The resulting transcript spanned over 2,300 pages. Over 53,000 pages of documentary evidence was submitted. During the preliminary hearing, the complaint was amended again. This final amendment contained 102 counts alleging a violation of section 550, subdivision (a)(6), and one count alleging a violation of subdivision (a)(5). Defendant was held to answer on all 103 counts.

Following the preliminary hearing, prosecutors filed an amended information containing 121 counts: 120 counts of violating section 550, subdivision (a)(6), and one count of violating subdivision (a)(5). the amended information, for each count, included both patient names and references to the preliminary hearing exhibit numbers containing the evidence relevant to the particular offense.

The court overruled a demurrer to several counts, finding notice to be adequate, and concluded the People were permitted to allege multiple acts that form the basis of each count. It cautioned, however, that there was still work to be done before setting a trial date to ensure the defendant had clarity on what he would need to defend against at trial.

In response, Hoffman filed the present petition for a writ of mandate directing the court to sustain the demurrer. The Court of Appeal initially summarily denied the petition. But the California Supreme Court granted review and instructed the Court of Appeal to issue an order to show cause.

The issue is whether an information may allege a single offense in a single count, but describe within that count multiple discrete acts, each of which constitute the charged offense.

The Court of Appeal just concluded this month that the information was proper and denied the writ petition in the published case of Sim Carlisle Hoffman v The Superior Court of Orange County.

Each count alleges a single offense. Any complications, or undue prejudice to defendant, arising from the fact that multiple discrete acts may constitute the charged offense in each count are adequately dealt with by a unanimity instruction at trial, or by other tools at the court’s disposal, such as a severance of counts, or trial continuances where appropriate. A demurrer on these grounds is not the proper vehicle to address defendant’s concerns.

The court correctly overruled the demurrer.

A total of 14.4 million beneficiaries of Medicare Part D, which offers Medicare recipients the opportunity to get federally subsidized prescription drug coverage, received at least one prescription for an opioid in 2016 while the Medicare Part D program paid about $4.1 billion to provide them with those drugs, according to a study by the inspector general for the Department of Health and Human Services.

Nationwide, 33 percent of all Medicare Part D beneficiaries got federally funded opioids in 2016. In Alabama, it went as high as 46 percent; in Mississippi, it was 45 percent; and, in Arkansas, it was 44 percent.

The IG’s discovery that 14.4 million Medicare Part D beneficiaries got an opioid prescription in 2016 was cited in a Government Accountability Office report.

‘The Centers for Disease Control and Prevention (CDC), reported that from 1999 to 2014 the rate of drug poisoning deaths from prescription opioids nearly quadrupled from 1.4 to 5.1 per 100,000 people,’ said the GAO report. ‘In addition, the Department of Health and Human Services (HHS) Office of Inspector General (HHS-OIG) reported that 14.4 million people (about one-third) who participate in Medicare Part D received at least one prescription for opioids in 2016, and that Part D spending for opioids in 2016 was almost $4.1 billion.”

The inspector general’s report – “Opioids in Medicare Part D: Concerns about Extreme Use and Questionable Prescribing” – was completed in July. “In 2016,” said the IG report, “one out of every three beneficiaries received at least one prescription opioid through Medicare Part D.”

Some of the Medicare Part D beneficiaries received an opioid prescription only for a short period of time. But others received an opioid on what the IG called “a regular basis” – and some received “high” or “extreme” amounts.Some beneficiaries also appeared to be “doctor shopping” in pursuit of opioids. The IG report stated:

— “Specifically, 5 million beneficiaries received opioids for 3 months or more in 2016.”
— “A total of 501,008 beneficiaries received high amounts of opioids through Medicare Part D in 2016. This does not include beneficiaries who had cancer or were in hospice care.”
— “A total of 69,563 beneficiaries received extreme amounts of opioids for the entire year, putting them at serious risk of opioid misuse or overdose. Each of these beneficiaries had an average daily MED [morphine equivalent dose] that exceeded 240 mg for the entire year, This extreme amount is more than two and a half times the dose the CDC recommends avoiding for chronic pain patients.”
— “A total of 22,308 beneficiaries appear to be doctor shopping. Each of these beneficiaries received a high amount of opioids – an average daily MED that exceeded 120 mg for at least 3 months – and have four or more prescribers and four or more pharmacies in 2016. Typically, beneficiaries who receive opioids have just one prescriber and one pharmacy.”

The IG also report noted that a number of prescribers – including doctors, nurses and physician assistants – also exhibited extraordinary patterns in the opioid prescription they issued to Medicare Part D beneficiaries:

The report recommended that the Centers for Medicare and Medicaid Services: “(1) gather information on the full number of at-risk beneficiaries receiving high doses of opioids, (2) identify providers who prescribe high amounts of opioids, and (3) require plan sponsors to report to CMS on actions related to providers who inappropriately prescribe opioids.”