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VA Promotes Telehealth, and E-Record Systems

The VA Mission Act of 2018 was designed to greatly improve veteran access to VA healthcare. This legislation’s formal name is the VA Maintaining Systems and Strengthening Integrated Outside Networks Act. The Act strengthens VA’s ability to deliver trusted, easy to access, high quality care at VA facilities, virtually through telehealth.

In the past, among of the chief complaints about VA healthcare involved timely scheduling of appointments, care and services. Under the VA Mission Act, the Department of Veterans Affairs is required to coordinate timely care including help for those who need VA medical services outside their region of residence.

The Act authorizes VA providers to use telehealth technologies to deliver care over state lines and into Veteran’s home, allowing VA to enhance the accessibility, capacity, and quality of VA health care. It also directs VA to implement a pilot program to establish mobile deployment teams to address and improve care in underserved areas.

As part of this process, VA is establishing access standards and standards for quality that will apply to VA facilities and community providers. The proposed access standards were announced January 30. They are based on analysis of best practices in government and the private sector and tailored to the needs of Veterans.

Veterans who access community care can expect a familiar process with several improvements through a new urgent care benefit, expanded eligibility criteria, and improved quality of care. Community providers can expect their interaction with VA will get easier with new IT systems, better communications, and more timely payments.

The VA says it is leading the health care industry in transparency by enabling Veterans to compare data across VA and the private sector so they can make informed decisions when selecting a provider. As Secretary Wilkie said in a recent statement, “we are giving Veterans the power to choose the care they trust, and more Veterans are choosing VA for their health care than ever before.”

Dr. Melissa Glynn serves as the assistant secretary for Enterprise Integration (OEI) and is responsible for leading efforts to continuously improve VA operations. Her office focuses on enhancing Veterans and employee experiences through effective enterprise integration and execution support of people, processes, technology, innovations and maturing management capabilities.

Another Opioid Manufacturer Pleads Guilty to Kickbacks

Opioid manufacturer Insys Therapeutics agreed with the government to a global resolution to settle the government’s separate criminal and civil investigations.

As part of the criminal resolution, Insys will enter into a deferred prosecution agreement with the government, Insys’s operating subsidiary will plead guilty to five counts of mail fraud, and the company will pay a $2 million fine and $28 million in forfeiture.  As part of the civil resolution, Insys agreed to pay $195 million to settle allegations that it violated the False Claims Act.

Both the criminal and civil investigations stemmed from Insys’s payment of kickbacks and other unlawful marketing practices in connection with the marketing of Subsys. Insys’s drug Subsys is a sublingual fentanyl spray, a powerful, but highly addictive, opioid painkiller.

In April 2018, the United States intervened in five qui tam lawsuits accusing Insys of violating the civil False Claims Act. In its Complaint, the United States alleged that Insys, headquartered in Arizona, paid kickbacks to induce physicians and nurse practitioners to prescribe Subsys for their patients.

In addition to payments for sham speaker program speeches, the kickbacks also allegedly took the form of jobs for the prescribers’ relatives and friends, and lavish meals and entertainment.

The United States also alleged that Insys improperly encouraged physicians to prescribe Subsys for patients who did not have cancer, and lied to insurers about patients’ diagnoses in order to obtain reimbursement for Subsys prescriptions that had been written for Medicare and TRICARE beneficiaries.

One practitioner targeted by Insys was a physician’s assistant who practiced with a pain clinic in Somersworth, New Hampshire. During the first year that Subsys was on the market, the physician’s assistant did not write any Subsys prescriptions for his patients. In May 2013, the physician’s assistant joined Insys’s sham speaker program knowing that it was a way to receive kickbacks for writing Subsys prescriptions. After joining the sham speaker program, the physician’s assistant wrote approximately 672 Subsys prescriptions for his patients – many of which were medically unnecessary – and in turn, received $44,000 in kickbacks from Insys.

As part of the criminal resolution, Insys agreed to a detailed statement of facts outlining its criminal conduct with respect to the illegal marketing of Subsys. Insys will enter into a five-year deferred prosecution agreement with the government, while Insys’s operating subsidiary will plead guilty to five counts of mail fraud pursuant to the plea agreement that will be filed in the District of Massachusetts.

The allegations resolved by the settlement stem from five lawsuits that were filed under the qui tam, or whistleblower, provisions of the False Claims Act, which permit private citizens to bring suit on behalf of the United States for false claims and share in any recovery.

HHS Publishes Pain Management Best Practices

The Pain Management Best Practices Inter-Agency Task Force was established to propose updates to best practices and issue recommendations that address gaps or inconsistencies for managing chronic and acute pain. The U.S. Department of Health and Human Services is overseeing this effort with the U.S. Department of Veterans Affairs and U.S. Department of Defense.

The Task Force has now just published its Final 116 Page Report.

50 million adults in the United States have chronic daily pain, with 19.6 million adults experiencing high-impact chronic pain that interferes with daily life or work activities. However, the Task Force emphasizes the importance of individualized patient-centered care in the diagnosis and treatment of acute and chronic pain.

This report is therefore “broad and deep and will have sections that are relevant to different groups of stakeholders regarding best practices.” It emphasizes the development of an effective pain treatment plan after proper evaluation to establish a diagnosis, with measurable outcomes that focus on improvements, including quality of life (QOL), improved functionality, and activities of daily living (ADLs).

A multidisciplinary approach for chronic pain across various disciplines, using one or more treatment modalities, is encouraged when clinically indicated to improve outcomes. These include the following five broad treatment categories, which have been reviewed with an identification of gaps/inconsistencies and recommendations for best practices:

Medications: Various classes of medications, including non-opioids and opioids, should be considered for use. The choice of medication should be based on the pain diagnosis, the mechanisms of pain, and related co-morbidities following a thorough history, physical exam, other relevant diagnostic procedures and a risk-benefit assessment that demonstrates that the benefits of a medication outweigh the risks. The goal is to limit adverse outcomes while ensuring that patients have access to medication-based treatment that can enable a better QOL and function. Ensuring safe medication storage and appropriate disposal of excess medications is important to ensure best clinical outcomes and to protect the public health.
Restorative Therapies, including those implemented by physical therapists and occupational therapists (e.g., physiotherapy, therapeutic exercise, and other movement modalities) are valuable components of multidisciplinary, multimodal acute and chronic pain care.
Interventional Approaches, including image-guided and minimally invasive procedures, are available as diagnostic and therapeutic treatment modalities for acute, acute on chronic, and chronic pain when clinically indicated. A list of various types of procedures, including trigger point injections, radio-frequency ablation, cryo-neuroablation, neuromodulation, and other procedures are reviewed.
Behavioral Approaches for psychological, cognitive, emotional, behavioral, and social aspects of pain can have a significant impact on treatment outcomes. Patients with pain and behavioral health comorbidities face challenges that can exacerbate painful conditions as well as function, QOL, and ADLs.
Complementary and Integrative Health, including treatment modalities such as acupuncture, massage, movement therapies (e.g., yoga, tai chi), and spirituality, should be considered when clinically indicated.

Continued medical and scientific research is critical to understanding the mechanisms underlying the transition from acute to chronic pain; to translating promising scientific advances into new and effective diagnostic, preventive and therapeutic approaches for patients; and to implementing these approaches effectively in health systems.

June 3, 2019 News Podcast


Rene Thomas Folse, JD, Ph.D. is the host for this edition which reports on the following news stories: Apportionment Limits Passed by CA Senate, One Defendant Remains in First Opioid Trial, Oklahoma Opioid Trial Highlights Marketing, School Officials Convicted for SJDB Voucher Fraud, ABC Test Proposed Law Adds Exemptions, Wellness Program Regulations Delayed – Again!, FDA Approves World’s Most Expensive Drug, Money Does Not Buy Better Comp Outcomes.

Ohio BWC Drops Oxycontin from Formulary

A plan by the Ohio Bureau of Workers’ Compensation (BWC) to phase out coverage for Oxycontin and its generic form by the end of the year began Saturday.

Given their potential for abuse, misuse, addiction, and dependence, BWC will no longer pay for Oxycontin or generic sustained-release oxycodone tablets for workers who suffer on-the-job injuries on or after June 1. Injured workers currently on those medications will have until Dec. 31 to discontinue their use or switch to a different product on the agency’s formulary.

“We are encouraging injured workers to discuss with their physicians other effective painkillers on our formulary and to explore non-medication treatment options for chronic pain,” said BWC Administrator/CEO Stephanie McCloud. “Our priority remains the health and safety of our injured workers, which can be more challenging when an addiction enters the mix.”

McCloud added that workers who want to discontinue opioid use altogether should talk to their physician or BWC-contracted managed care organization. BWC will reimburse for certain services.

Ohio Governor Mike DeWine lauded the agency’s new rule.

We want to prevent addiction, and I believe that this change will make an impact on Ohio’s opioid epidemic by promoting the safest possible treatments for injured workers with painful conditions,” said Governor DeWine.

The rule does not apply to immediate-release oxycodone, a medication used for acute pain.

Approved by BWC’s board of directors in February, the rule follows a thorough study over the last year by BWC’s pharmacy and therapeutics committee, which is comprised of physicians and pharmacists in the workers’ compensation system. It also follows a series of actions in recent years to mitigate the opioid epidemic’s impact on Ohio’s workforce.

The agency’s 2016 Opioid Rule, for instance, requires physicians follow specific best practices when prescribing opioids to injured workers.

So. Cal. Contractors Cited for $600K Wage Theft

The Labor Commissioner’s Office has issued citations totaling $597,933 in unpaid wages and penalties to Universal Structural Building Corp. of Chatsworth after 62 construction workers were never paid for weeks of work on two projects in Hollywood and Ventura.

J.H McCormick Inc., a general contractor for one project, was named jointly and severally responsible for $68,657 of the citations pursuant to a section of the labor code added last year by Assembly Bill 1701 that holds general contractors liable for their subcontractor’s wage theft violations.

Universal Structural Building is a subcontractor that provides concrete building services for residential and mixed-use developments at jobsites in Los Angeles and Ventura. J.H McCormick and Universal signed a contract in February 2018 for a residential and commercial project, the Essex Hollywood. A large group of Universal’s employees came to the Labor Commissioner’s Office last November after working five to six days a week for eight to 14 hours a day without pay for the final weeks of that project. Investigators filed a mechanic’s lien in December to secure $110,000 for 39 of the 42 workers affected by the wage theft on this project.

Investigators also received reports of wage theft at the Portside Ventura Harbor project when another group of Universal’s workers came to the Labor Commissioner’s Office in January. Workers said when they asked for their final pay they were told the company had no money, and the general contractor was supposed to pay them. The Labor Commissioner’s Office filed another mechanic’s lien against Universal to secure $26,464 in wages for the 20 workers. The project’s general contractor could not be held liable in the citations as the contract began prior to January 1, 2018.

The investigation into both projects determined that Universal Structural Building employees are owed $477,533 in unpaid wages and penalties, with an additional $49,220 for contract wages due. The citations issued include:

— $62,207 in unpaid minimum wages and $64,131 in liquidated damages for 62 employees
— $4,900 in unpaid overtime for 37 employees
— $15,950 for wage statement violations owed to 62 employees
— $330,345 in waiting time penalties owed to 62 employees
— $120,400 in civil penalties, including $15,000 for misclassifying a foreman as an exempt employee

The Labor Commissioner’s Office has filed a civil action with the Los Angeles Superior Court against J.H McCormick to help secure funds to pay back wages.

The mechanic’s lien is an important collection tool for construction laborers who have suffered wage theft. California’s Constitution has guaranteed the right of construction workers since 1879 to obtain a court-ordered sale of property that they have worked on in order to recover unpaid wages, even if hired by a subcontractor. Workers should exercise their mechanic’s lien rights within 90 days of the work being completed or they may lose their right to file.

CA AG Belatedly Files Limited Opioid Litigation

The California Attorney General announced that California is suing Purdue Pharma L.P., Purdue Pharma Inc., certain of its affiliates, and Dr. Richard S. Sackler, former President and board member of Purdue, for unlawful practices in the marketing, sale, and distribution of opioids. The 56 page complaint was filed in Los Angeles Superior Court on June 3.

In addition to the lawsuit filed by the California Attorney General, the District of Columbia, Hawaii, and Maine each filed individual suits against Purdue the same day.

These states join more than 40 others, including hard-hit Ohio and West Virginia, and about 2,000 local and tribal governments, that have already filed lawsuits against Purdue for fueling the opioid epidemic.

However, these newest states seem to be way behind the litigation curve, as other states have been in litigation for years, and one is currently in one of the first trials.

Oklahoma was the first state to announce major settlements this year, and kicked off the first trial in May against remaining defendants. In March, Purdue Pharma, the maker of OxyContin, agreed to a $270 million settlement with the state.

And then Teva announced an $85 million settlement with the state of Oklahoma over its alleged role in fueling the opioid crisis. Trial is currently in progress against a remaining defendant Johnson & Johnson.

The California lawsuit alleges that Purdue’s illegal and misleading marketing and sales practices played a major role in contributing to the nationwide opioid crisis. It further alleges that Purdue created a public nuisance through its marketing and sale of opioids and misled healthcare professionals and patients about the addictive nature of opioids and their potential for abuse and diversion.

What is missing from the California suit are the other traditional defendants. Most other suits include other opioid manufacturers such as Endo Pharmaceuticals, and Johnson & Johnson’s Janssen Pharmaceuticals, among others,

Also missing from the California litigation are distributors – including Amerisource Bergen, McKesson Corp., and Cardinal Health (known as the “Big Three”) – who allegedly distributed more than 80 percent of the opioids at issue and failed to monitor, investigate, refuse, or report suspicious orders of prescription opioids, flooding states with the drugs.

Mild Brain Injury Can Cause Lasting Effects

People who have mild traumatic brain injuries may be more likely to have lasting functional deficits that get in the way of daily activities than patients who experience other types of injuries, a U.S. study published in JAMA Neurology and summarized by Reuters Health suggests.

The new study involved 1,154 patients with mild traumatic brain injuries and 299 patients with orthopedic injuries but no head trauma.

Two weeks after their injuries, 87 percent of brain injury patients and 93 percent of the other trauma patients reported functional limitations, a difference that was too small to rule out the possibility that it was due to chance. The groups remained on a similar trajectory until six months after their injuries.

After one year, however, brain injury patients fared worse. By this point, 53 percent of them still had functional limitations, compared with 38 percent of the other trauma patients.

“Unfortunately, many patients with mild traumatic brain injuries do not get any follow-up care after being discharged from the hospital,” said study leader Lindsay Nelson of the Medical College of Wisconsin in Milwaukee. While patients with moderate to severe brain injuries are almost always admitted to a hospital or intensive care unit, there’s less consensus about the best way to manage people with milder injuries.

Even when brain injuries are called “mild,” they can still lead to persistent physical, psychiatric and cognitive problems that result in lasting impairments and disability, especially when people go untreated.

Car crashes were the most common cause of brain injury in the study, accounting for 36 percent of cases, followed by falls at 24 percent.

The study wasn’t a controlled experiment designed to prove whether or how different types of traumatic injury might directly cause distinct functional deficits over time.

One limitation of the analysis is that researchers only included patients treated at level 1 trauma centers – hospitals that see the most serious cases, the study team notes. And, they only looked at patients who had head CT scans to confirm whether they had brain injuries.

SCIF Launches Real-Time UR Approval

The State Compensation Insurance Fund will test out new software that lets them provide authorizations for patient treatments in real-time – through their electronic medical records – rather than waiting several days for decisions to come via fax.

The article in the Sacramento Bee reports that Dr. Dinesh Govindarao, chief medical officer for the State Compensation Insurance Fund, said his agency decided to fund development of the software because leaders wanted to get care approved faster for injured workers.

Although State Fund developed the new software, known as UR Connected, Govindarao said, it is something they believe could benefit any workers’ comp insurer, and he is hoping that other insurers will want to adopt it.

UR Connected integrates with and leverages existing information systems in the medical providers’ offices, so neither the providers nor their staff have to go offline and fill out paperwork to request approvals for patient treatment, said J.R. Long, an executive with Conexia, the software company that developed UR Connected for State Fund.

“If the system is more efficient and patient care is rendered faster, then folks are hopefully getting back to work sooner, and that will then really reduce indemnity cost (for disability pay),” Govindarao said, “and also if care is not being delayed, hopefully even medical costs will go down because they’re getting care faster and there’s maybe less risk of complications.”

Govindarao said: “What we wanted to do was change that up, so in real time, the physician who is requesting that, they would right then and there get a response: Either yes, go ahead and treat, or we need to escalate this for utilization review.”

With UR Connected, Govindarao said, evidenced-based medical procedures would get approved while patients are still in the exam room if State Fund covers them, and requests that require utilization review will be sent to the appropriate personnel more quickly.

Long added: “You’re able to manage by exception, so the things you need to get involved in, you can put your resources toward that as opposed to the events or activities that today are happening in this…manual fashion. You can redirect those staff to more value-added activities both for the insurer and ultimately for the provider and the patient.”

Stuart Sweetser, who works in State Fund’s medical claims division, said that, as the technology gets more widely adopted, some of State Fund’s staff will get different assignments but that State Fund does not foresee any layoffs.

Govindarao said that “the manual tasks probably will never go away. For that to happen, we’d have to have 100 percent adoption with every provider out there, which I think is probably not going to happen. But I think, if we have over 70-80 percent as a target, down the road.”

State Fund is paying Conexia to help ensure the UR Connected system can be smoothly adapted to the various information systems that doctors, hospitals and other types of medical practitioners use, Govindarao said, and they hope to get large groups and high-volume practitioners set up with the system soon.

If providers aren’t ready to integrate their information systems with UR Connected, Govindarao said, they have the option of going through a website portal to request approvals for treatments. The plan, he added, is to also integrate with bill payment to try and get practitioners paid faster.

Quest Diagnostics Records Hacked

Medical testing giant Quest Diagnostics has confirmed a third-party billing company has been hit by a data breach affecting 11.9 million patients.

The laboratory testing company revealed the data breach in a filing on Monday with the Securities and Exchange Commission.

According to the filing, the breach was a result of malicious activity on the payment pages of the American Medical Collection Agency, a third-party collections vendor for Quest. The “unauthorized user” siphoned off information from the website, like credit card numbers, as well as medical information and personal data from the site.

But laboratory tests were not included in the stolen data, Quest said.

The breach dated back to August 1, 2018 until May 31, 2019, said Quest, but noted that it has “not been able to verify the accuracy of the information” from the AMCA.

Quest had been informed of the breach by American Medical Collection Agency, an Elmsford, New York-based collections firm. For eight months, an unauthorized user had access to personal information including credit card numbers and bank accounts, medical information, and personal information such as Social Security numbers.

Quest said it has suspended sending collections requests to AMCA and is working with law enforcement and with UnitedHealth on the effects of the breach.

Quest said it was informed of the incident on May 14. Several other companies have been hit in recent months by attacks on their websites.Highly targeted credit card skimming attacks hit Ticketmaster, British Airways, and consumer electronics giant Newegg in the past year, affecting millions of customers.

The so-called Magecart group of hackers would break into vulnerable websites and install the malicious code to skim and send data back to the hacker-controlled servers.

It’s the second breach affecting Quest customers in three years.