Partner of the Month: LDN

June 2, 2020

Chronic Pain and Low Dose Naltrexone

Naltrexone is a class of drug known as an opiate antagonist. It is licensed for use in treating opiate and alcohol dependence at doses of between 50 mg and 300 mg daily. At these doses, the opioid receptors are blocked for an extended period, thus suppressing the cravings for opiates or alcohol.

The first clinician to record immunological effects of Low Dose Naltrexone (LDN) was Dr Bernard Bihari in 1985. His primary line of research at that time was with HIV/AIDS. He was trying to improve the survival rate of seriously immune-compromised patients.

Dr Bihari knew from previous research that endorphins were significantly involved in the regulation of the immune system, it was an ingenious step to try treatment with LDN. On finding that giving LDN daily to his patients improved their outcomes dramatically, it inspired a plethora of research on the importance of endorphins and opiate antagonists to the regulation of the immune system.

Over the next 29 years, Dr Ian Zagon championed the fundamental research into endorphins and LDN. He published almost 300 papers on the subject and it was confirmed, without doubt, that the endorphin/opiate receptor system is involved in virtually every biological system that regulates immune response.

The Mechanism of Action of LDN

The first thing to understand about the mechanism of action is that Naltrexone – the drug in LDN – comes in a 50:50 mixture of 2 different forms (called isomers). It has recently been discovered that one form binds to immune cells, while the other variant binds to opioid receptors. Although consisting of precisely the same components, the two isomers appear to have different biological activity.

Levo-Naltrexone (the left-handed version) is an antagonist for the opiate/endorphin receptors

o This causes increased endorphin release

o Increased endorphins modulate the immune response

o This reduces cell proliferation via endorphins

Dextro-Naltrexone (the right-handed version) is an antagonist for at least one, if not more, immune cells and is reported to:

o Antagonise “TLR,” suppressing cytokine modulated immune system

o Antagonise TLR-mediated production of NF-kB – reducing inflammation, potentially downregulating oncogenes

How LDN Works for Pain

It was found that low doses of naltrexone, at 1/10th of the dose used for opiate dependence, has beneficial effects on those suffering from many autoimmune disorders.

For chronic pain patients, the central nervous system gets overwhelmed; pain signals become out of control and drown the body’s natural pain-relieving systems. Temporary blockage of the opiate receptors prompts the body to upregulate endogenous opioids and receptors. This rebound effect restores balance to the opioid system.

The main goal of LDN is to slow or halt the progression of the disease. When LDN normalises the immune system, it halts the further progression of autoimmune disease, relieving inflammation and pain and consequently stress, which often leads to exacerbations of a wide variety of autoimmune conditions. Aside from better pain control, benefits derived from the use of LDN include decreased fatigue, improved mood, reduced sleep disturbances, and enhanced cognitive function.

Trials and Studies

There are many clinical trials for the use of LDN for the treatment of autoimmune conditions such as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Fibromyalgia (FM), Complex Regional Pain Syndrome (CRPS), Sjogren’s Syndrome, Stiff Person Syndrome, Neuropathic Corneal Pain and LDN for Cancer. Past papers for these conditions and more are on the LDN Research Trust website.¹ The list of illnesses that have shown benefit from LDN is long, but most are the result of just one thing – a dysfunctional immune system.

Sjogren’s Syndrome

Is a chronic autoimmune disorder that causes inflammation of the lacrimal and salivary glands that results in dry eyes and mouth as well as fatigue and musculoskeletal pain. A case study conducted by Scott Zashin describes a 47-year-old female who had no improvement on standard therapy for five years from diagnosis. After that time, the lady sought a second opinion from Scott Zashin and she elected to try LDN therapy. After two weeks she reported feeling “Terrific” and her lab work showed normal for ESR, CRP and ALT. After some adjustments to dosage over time, the patient noted significant benefit with her fatigue and pain. While her symptoms improved, what was most interesting about the case was that her clinical improvement was associated with an improvement in her inflammatory markers.²

ME/CFS

Is a medical condition that limits physical and cognitive functions, and there is no known effective treatment. One retrospective open-label study concluded that a study should be initiated to confirm the feasibility of LDN to alleviate the symptoms of ME/CFS.³ In this study, 46% of the group experienced no adverse side effects, 54% reported mild and temporary adverse effects (commonly transient insomnia, vivid dreams and headaches). In comparison, almost 74% reported varying degrees of symptomatic relief during LDN therapy.

Kent Holtorf, MD, authored a chapter in “The LDN Book – How a Little-Known Generic Drug – Low Dose Naltrexone – Could Revolutionize Treatment for Autoimmune Diseases, Cancer, Autism, Depression and More”, Edited by Linda Elsegood. In his chapter, he describes treating Chronic Fatigue and Fibromyalgia patients with LDN. Dr Holtorf’s treatment plan is to

Stabilise the patient
Enhance mitochondrial function
Balance the hormones
Treat the immune dysfunction
Treat any infections/immune components
Address any unique etiologies
Adjust treatment as needed

Of all of these steps, he declares that step 4 is possibly the most important aspect of the treatment and a therapeutic trial of LDN should be considered in the majority of these patients not on narcotic pain medication. Now that the use of uLDN (ultra Low Dose Naltrexone) is known to help increase the efficacy of opioids while weaning patients off it, LDN may possibly be used in that circumstance too.

In a peer reviewed and published analysis of over five hundred CFS and FM patients, on Dr Holtorf’s treatment plan, 94% of patients had overall improvement at the fourth visit, 75% noted a significant overall improvement, 62% reported substantial overall improvement and the average energy level and sense of well-being for patients doubled by the fourth visit.⁴ Standard treatment for these conditions involves drugs with unpleasant side effects such as muscle relaxants, antidepressants, NSAIDS and some physiotherapy – these only minimally addressed the symptoms and ignored the cause entirely.

A review published by Joyce et al found that “Of 26 studies identified, four studied fatigue in children, and found that 54-94% of children recovered over the periods of follow-up. Another five studies operationally defined chronic fatigue syndrome in adults and found that less than 10% of subjects return to pre-morbid levels of functioning, and the majority remain significantly impaired”.⁵ Compare these results to Dr Holtorf’s analysis, and there is a clear case for his method and the use of LDN in cases of ME/CFS and FM.

Complex Regional Pain Syndrome (CRPS)

CRPS is predominantly nerve pain that usually starts after some form of trauma. CRPS is said to be the most painful condition known to exist and is quite common. A case study by Pradeep Chopra, MD, of a 15-year-old girl who developed CRPS after she sprained her left ankle: the pain suffered by this patient got steadily worse over a three-year period despite many tests that appeared normal, extensive physical therapy, spinal injections and medications. The pain started to mirror in her right leg, and the condition worsened to the point where she was confined to a wheelchair suffering constant pain. At the age of 18, after one attempted suicide and other complications arising such as muscle atrophy, dystonia to the left ankle and postural orthostatic tachycardia syndrome, the patient was started on a treatment of low dose IV ketamine and LDN. She showed a good initial response to ketamine and the ketamine was reduced and stopped after three months just leaving her on the LDN with significant improvement in pain and function. Within a year, along with physiotherapy, she was able to get rid of her wheelchair and now walks unaided.⁶

Rheumatic and Arthritic Pain

Clinical research on LDN in rheumatic disease and arthritis, in general, is limited; however, one pharmacoepidemiologic study tested the hypothesis that the use of LDN reduced the use of conventional rheumatic disease medications. In a controlled before and after study, prescriptions were looked at a year before and a year after the patients commenced LDN and the outcomes showed the differences in the drugs dispensed. The results of the study suggested that the compliant use of LDN reduced the dispensing of several medications used in rheumatoid and seropositive arthritis, drugs such as DMARDS, NSAIDs and Opiates. In conclusion, the authors state that “The results support the hypothesis that persistent use of LDN reduces the need for medication used in the treatment of rheumatic and seropositive arthritis. Randomised clinical trials on LDN in rheumatic disease are warranted.”⁷

Dosing Guide – LDN and uLDN

The prescribing regimen for LDN depends on the condition being treated and of course on the individual as each can be different regarding toleration, lifestyle, other drugs prescribed etc. In general, the guide is to start low and slowly work up from 0.1mg to 4.5 mg over a period of weeks or months. If side effects occur, then the advice is to halve the dose and build up slowly again – this usually resolves the issue with side effects.

Because LDN is a potent opioid antagonist, the use of LDN for patients on opioid pain medication is not recommended for fear of triggering an opioid withdrawal reaction. However, ultra Low Dose Naltrexone (uLDN) can be used in micro doses alongside opioids to help wean patients off opioids without going through withdrawal symptoms and still controlling pain. After a few weeks, patients take Low Dose Naltrexone (LDN) to control the pain or use LDN alongside other medication.

The LDN Research Trust has recently released a documentary regarding Opioids and Pain Management and how LDN can assist with treatment, this documentary can be found here: https://www.ldnresearchtrust.org/ldn-documentaries-english or on YouTube https://www.youtube.com/watch?v=3mZX77vSY1w&t=2128s

Conditions where LDN could be of benefit

Go to https://www.ldnresearchtrust.org/conditions

The LDN Book Volume 2 Launch and Tour

Starting October 14^th 2020 https://www.ldnresearchtrust.org/ldn-book-2-launch-and-tour

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https://www.ldnresearchtrust.org/ldn-clinical-trials
Scott Zashin, “Sjogren’s Syndrome: Clinical Benefits of Low Dose Naltrexone Therapy”, Cureus, 11, 3 (March 2019), e4225, https://doi:10.7759/cureus.4225
Olli Polo, Pia Pesonen & Essi Tuominen, (2019) “Low-Dose Naltrexone in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)”, Fatigue: Biomedicine, Health & Behavior, 7, 4 (2019), 207-217: https://doi:10.1080/21641846.2019.1692770
Power point presentation, Kent Holtorf, MD https://www.ldnresearchtrust.org/sites/default/files/Dr%20Kent%20Holtorf%20LDN%20and%20CFS-FM_0.pdf
J. Joyce, M. Hotopf and S. Wessely, “The Prognosis of Chronic Fatigue and Chronic Fatigue Syndrome: a Systemic Review”, QJM: An International Journal of Medicine, 90, 3 (March 1997) 223-33. https://doi.org/10.1093/qjmed/90.3.223
Pradeep Chopra, MD, https://www.ldnresearchtrust.org/sites/default/files/Manangement%20of%20chronic%20pain%20with%20LDN%20-%20Chopra%202017.pdf
Guttorm Raknes and Lars Småbrekke, “Low Dose Naltrexone: Effects on Medication in Rheumatoid and Seropositive Arthritis. A Nationwide Register-Based Controlled Quasi-Experimental Before-After Study”, Plos One, Research Article (February 2014), https://doi.org/10.1371/journal.pone.0212460

Telehealth IT Security: What Clinicians Need to Know & Tips to Keep Your Practice Secure

May 27, 2020

While the surge in online medicine has increased accessibility, allowed greater flexibility, and helped medical practices remain operational at this time, the rapid expansion of telemedicine presents its own set of risks. Data privacy, online patient safety concerns, and other cybersecurity threats are on the rise, as the pandemic has many emerging telemedicine solutions entering the market before proper vetting and without proven safety records.

As new technologies are introduced to meet increasing patient demand and a growing number of medical professionals switch to digital care delivery, protecting online patient data and ensuring compliance with federal regulations are paramount. Telemedicine has been shrouded in security and privacy concerns since its inception, with several large-scale, high-profile data breaches threatening to diminish patients’ and providers’ willingness to trust emerging solutions. In addition, more patients are now readily exchanging their privacy online for the benefit of immediate care and to avoid the public healthcare setting due to virus-related fears.

“Telehealth was trending upward before the pandemic, and there were already privacy and security concerns,” Dr. Stephen Hyduchak, CEO of the identity-verification service Aver, told Managed Healthcare Executive “But those are heightened now as people want the immediacy of care and are ready to accept the exchange of privacy to receive that.”

Data Privacy and Regulations

To ease the implementation of telehealth solutions, federal regulations have lessened the enforcement of HIPAA restrictions throughout the pandemic to ensure patients can access the care they need while curbing the spread of COVID-19. Practitioners are now able to utilize popular telecommunications services, such as Zoom and Skype, which allow for easy patient-provider communication but present potential data privacy concerns.

In recent weeks, a growing number of hacker attacks have been reported on Zoom domains and other similar platforms used in telemedicine, underscoring possible threats associated with these popular services. There has also been an increase in COVID-19 fraud schemes and supply chain attacks as cyber criminals take advantage of increased online activity.

Telehealth IT Security Best Practices

Threats to IT security in the clinical setting can range from phishing attacks and ransomware to loss of equipment and accidental data loss. While the risks depend on the type of service being provided, virtually all telehealth interactions are susceptible to cybersecurity breaches.

The increased cybersecurity risks affecting digital health services result from expanded lists of users accessing networks and software from different locations as well as a surge in untested solutions brought to market – all of which exacerbate online security, data privacy, and regulation compliance threats.

Healthcare professionals and organizations must remain aware of and alert to the multitude of cybersecurity concerns threatening their online practice; following some of the telehealth IT security best practices below can help practitioners better protect themselves and their patients.

Invest in Cybersecurity Insurance

Prior to adopting a telemedicine practice, healthcare providers should consult their malpractice insurance company to ensure digital services are covered by their current policy. It may be a good idea to purchase cyber protection insurance along with the standard business insurance package to help cover any potential repercussions associated with a data breach. These can include the costs of forensics, notification and call center costs, credit monitoring fees, as well as public relations and legal fees. Purchasing an effective cybersecurity policy can also help prevent data breaches as they provide protective software, employee training, and IT security support.

Ensure VPN Security

While establishing a telehealth practice, it is essential practitioners use virtual private networks (VPNs) as part of their protected communications while connecting remotely to enterprise networks. The use of these networks can help ensure sensitive data is encrypted and passes through appropriate corporate channels before being disseminated through internet-hosted software. Per recent data reported by Health IT Security, the use of VPNs has surged by 124% in the past several weeks alone leading to growing concerns over network safety.

Healthcare professionals and organizations must ensure their VPN software is functioning and up to date and to mitigate any potential system vulnerabilities in order to protect sensitive patient information.

Encrypt Mobile Devices

With lessened restrictions, practitioners can access protected health information and telemedical technologies from their personal devices allowing them to deliver virtual care easily and effectively. However, the use of non-corporate devices carries several potential cybersecurity risks and providers are urged to employ appropriate device management strategies to offer secure medical services. These include segregating personal devices and applications from healthcare applications and data – a solution that can significantly reduce the risk of data leaks – as well as encrypting all devices.

Lost or stolen devices – mobile phones, desktop computers, laptops, and USB drives – are the leading cause of data breaches. While HIPAA regulations provide some protection for the loss or theft of encrypted data, the vast majority of electronic breaches result from unauthorized access to unsecured devices. Medical practices and providers are urged to ensure that all mobile devices, software, communication systems, and stored data are encrypted and that telemedicine security policies are followed by all employees.

Establish Telehealth Guidelines

Telehealth cybersecurity guidelines are essential to protecting against potential breaches as employee access is one of the most challenging risk factors to manage. A recent IBM study reported that nearly 95% of all data breaches resulted from employee error – including the loss or theft of devices, accidental sharing of information with incorrect recipients, sending sensitive patient data in unencrypted formats, or falling victim to ransomware attacks.

Establishing and training staff on effective telehealth practice guidelines is necessary to ensure optimal cybersecurity at this time; all staff members should be aware of practice policies regarding online care, HIPAA compliance requirements, data handling procedures, and personal health information protection strategies.

Use Reputable Software

The sudden popularity of telehealth services has prompted the introduction of novel software technologies, many of which have yet to be adequately tested. Healthcare providers should only download applications from reputable sources and utilize only those which are approved and deemed safe. Organizations may already have telemedicine systems in place, however, practitioners are encouraged to double-check with their human resources department before connecting to new platforms.

Understand How Platforms Manage Data

Having a robust understanding of the data collection, storage, management, and destruction practices of your chosen telehealth platform is essential to ensuring compliance with regulations and patient data safety. The majority of reputable providers should feature codes of conduct and explicit information regarding their data use policies and HIPAA compliance.

“Look for telemedicine providers that explain their use of data that you share, usually doing this in writing with a code of conduct,” Dr. Hyudchak added. “You have to make sure the telehealth service is reputable and that it’s following all HIPPA rules. Also, only disclose relevant information that is absolutely essential.”

Protect Against Unauthorized Access

The use of identity authentication systems is a critical tool for online safety. To protect against unauthorized access to sensitive data, many healthcare organizations use multi-factor authentication which is reported to block up to 99.9% of all automated cyberattacks. This strategy allows users to log in only after they present two or more pieces of evidence confirming their identity, thereby significantly decreasing the risks of breaches.

A common method hackers use to obtain access to protected health information is by capturing or guessing passwords. This threat can be reduced via identity authentication and the use of strong passwords that are frequently changed to prevent against password theft. Systems should lock users out of their accounts after three failed attempts and limit user access to sensitive databases.

While telehealth is a necessary and beneficial solution during the COVID-19 crisis and beyond, its growing use can jeopardize the safety of sensitive patient data and their privacy. As the majority of non-emergency patient-provider encounters are now occurring in the digital space, cybersecurity threats have reached an all-time high. Many emerging technologies are still new to most users yet cyber criminals have already begun to exploit vulnerabilities in networks and software, leveraging the widespread expansion of telemedicine as a platform for attack. The number of telehealth interactions will continue to increase as the COVID-19 pandemic reshapes the healthcare system, prompting the need for medical professionals and organizations to prioritize personal and patient cybersecurity.

Medicare COVID-19 Telemedicine Factsheet

May 20, 2020

The COVID-19 outbreak has not only disrupted daily life across the globe, but the contemporary healthcare model as well, with an urgently needed shift to digital medical solutions. Federal regulations are changing continuously, insurance coverage has greatly expanded, and the use of telemedicine is growing at a tremendous rate assisted by new policies and a widespread loosening of restrictions previously impeding access to care.

As part of the battle against the novel coronavirus pandemic, the Centers for Medicare & Medicaid Services (CMS) have expanded access to Medicare telehealth services on a temporary and emergency basis and lessened HIPAA enforcement effective as of March 6, 2020. These updates offer Medicare beneficiaries – many of whom are at an increased risk for serious COVID-19 illness – a safe, alternative model of care in the form of a wider range of remote services. During the COVID-19 crisis, innovative uses of telemedicine technology are driving routine care, keeping vulnerable demographics safe, and expanding access to health care.

“The benefits are part of the broader effort by CMS and the White House Task Force to ensure that all Americans – particularly those at high-risk of complications from the virus that causes the disease COVID-19 – are aware of easy-to-use, accessible benefits that can help keep them healthy while helping to contain the community spread of this virus,” a statement from the CMS on the promotion of telemedicine reads. Further information about the newly implemented guidelines for patient care and their implications on telehealth services during the COVID-19 outbreak are outlined below.

Expansion of Telehealth Services

1135 Waiver

As part of the program, the 1135 waiver was introduced to lessen prior restrictions and promote wider access to remote care. Prior to the waiver, Medicare was only able to pay for telehealth on a limited basis, for example, when a patient was receiving care in a designated rural area or when received the service in a healthcare facility. Under this waiver, the following changes have taken effect:

• Office, hospital, and other telehealth visits will now be covered and reimbursed for the same amount as an in-person visit.

• A wide range of providers can offer telehealth services across the nation, including nurse practitioners, psychologists, and licensed social workers.

• Medicare beneficiaries are now be able to receive a wider variety of services through telemedicine – such as evaluation and management visits, mental health counseling, and preventative health screenings.

• The HHS Office of Inspector General is providing flexibility for healthcare providers to reduce or waive cost-sharing for telehealth visits paid by federal healthcare programs during this time.

Virtual Services

Medical professionals can provide their Medicare patients with a range of virtual services as part of the telehealth program, including Medicare telehealth visits, virtual check-ins, and e-visits. Specific requirements for each service are outlined below.

Medicare Telehealth Visits

Throughout the course of the COVID-19 outbreak, Medicare patients may use digital technology for office, hospital visits, and other services previously rendered in-person. The recent changes include:

• A wider range of practitioners is now able to get payment covered for telemedicine services – including physicians, nurse practitioners, physician assistants, midwives, anesthetists, psychologists, clinical social workers, registered dietitians, as well as nutritional professionals.

• Virtual visits will now be paid at the same rate as regular, in-person visits.

• Providers must use an interactive audio and video system permitting real-time communication during Medicare telehealth visits in order to be reimbursed appropriately.

• New CMS guidelines remove the requirement of an established patient-provider relationship for the duration of the public health emergency, further details below.

“The Department of Health and Human Services (HHS) is announcing a policy of enforcement discretion for Medicare telehealth services furnished pursuant to the waiver under section 1135(b)(8) of the Act. To the extent the waiver (section 1135(g)(3)) requires that the patient have a prior established relationship with a particular practitioner, HHS will not conduct audits to ensure that such a prior relationship existed for claims submitted during this public health emergency,” the CMS statement reads.

Virtual Check-ins

In all areas of the country, Medicare beneficiaries will be able to have brief online check-ins with practitioners – or brief communication technology-based services. Policy changes related to this include:

• Medicare will now pay for virtual check-ins for patients with established relationships with their physicians to prevent unnecessary travel and office visits.

• Brief virtual check-ins can be conducted using a broader range of communication methods than Medicare telehealth visits; medical practitioners may bill for virtual check-in services provided via several telecommunication technologies – including telephone, audio/video, secure text messaging, email, and patient portals.

• Services cannot be related to a medical visit within the previous 7 days or lead to a medical visit within the following 24 hours, or the soonest available appointment.

• Patients must verbally consent to receive virtual check-in services.

• Patients can submit video/images using store and forward methods to be interpreted by physicians within 24 business hours.

E-Visits

As part of the updated guidelines, established Medicare patients in all types of locations can have non-face-to-face patient-initiated communications with their providers using online patient portals. These services can only be rendered in accordance with the following guidelines:

• E-visit services can only be reported to Medicare if the billing practice has an established relationship with the patient.

• E-visits must be initiated by the patient although, practices may educate patients on the availability of these services prior to their initiation.

• Communications can occur over a 7-day period and only after the patient provides verbal consent to receive telehealth services.

• These services may be billed using CPT codes 99421-99423 and HCPCS codes G2061.

More information on relevant billing codes for e-visits and other virtual care services can be found on the CMS’ website.

Health Insurance Portability and Accountability Act (HIPAA) Updates

In addition to the amendments above, the HHS Office for Civil Rights will lessen restrictions and waive penalties in association with HIPAA compliance for health care providers that serve patients in good faith through virtual communication technologies during the COVID-19 outbreak. More information on the latest HIPAA updates can be accessed here.

Although Medicare already offers flexibility to states that wish to implement telehealth services, the most recent developments signal a major step forward in the direction of telemedicine, despite the temporary nature of federal guidelines. With the help of changes in regulations and the strategic expansion of telehealth, patients can now reach providers easily via a range of tele communication options from the comfort and safety of their homes, while medical professionals can readily provide care without reimbursement concerns. As the COVID-19 public health emergency continues to evolve rapidly, regulations and guidelines may change; clinicians are encouraged to stay up-to-date on the latest medical guidance.

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