Technological and scientific advancements have dramatically altered the treatment landscape in several disease states. These include orphan diseases and conditions that previously had no disease-modifying treatment options. These innovative therapies have also come with unprecedented costs, with some agents introduced at a price exceeding one million dollars for a single patient. Value-based purchasing arrangements (VBPs) have attempted to manage the initial cost of these agents. In a VBP, which is sometimes referred to as an outcome-based arrangement, the ultimate price that is paid for the drug is dependent on the clinical outcome. In addition to a plan’s traditional utilization management initiatives to maintain sustainability, this strategy aims to hold pharmaceutical manufacturers responsible for the result of their product. This is similar to other healthcare environments, such as when readmissions impact hospital reimbursement. Under VBPs, a pharmaceutical manufacturer would issue a reimbursement if their product failed to produce the desired clinical outcome. In addition, this strategy incentivizes the development of unique therapies that are more likely to have a clinically significant impact. Novel medications that improve outcomes would provide a greater healthcare value and could be priced higher in the market. Currently, volume is a large driver of cost, with discounts from pharmaceutical manufacturers often tied to the number of units dispensed. This is less helpful for niche-area pharmaceuticals and genuinely innovative treatments used for uncommon conditions.

Practical considerations of VBPs, such as a higher administrative burden (e.g., paperwork, electronic database access, automated retrieval of data), limit their application to all products. Since it can be expensive to measure outcomes in order to assess the worth of a product to an individual patient or plan, VBP concepts are most commonly applied only to the costliest medications. For instance, VBPs can have a significant impact on the pricing of agents like gene therapy or select oncology agents. Some of these agents can have a large clinical impact on disease progression, survival, or quality of life, but a drug may not have the same results in all patients. However, value-based or outcome-based pricing may provide an increased incentive to payers by decreasing their initial risk and providing more sustainable treatment coverage.

While there has been an increase in the use of VBPs by states, manufacturers, and other payers in order to control drug spending and tie patient outcomes to cost, uncertainty remains in developing novel VBPs. The Medicaid Drug Rebate Program (MDRP) created by Congress under the Omnibus Budget Reconciliation Act of 1990 ensures that Medicaid receives the lowest net price for a single source drug or innovator multiple source drug during the rebate period charged to any payer. Simply put, pricing net of all discounts, must be reported to Medicaid, and the best price would have to be offered to Medicaid as well. It is critical that Medicaid programs continue to receive the lowest price available for a single source drug or innovator multiple source drug.

On June 19, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule that is aimed at promoting VBP flexibility for a variety of payers, including Medicaid, with a goal of maintaining a best price for Medicaid. CMS notes that best price creates challenges related to the availability of VBP arrangements. For example, under existing best price rules, if an individual fails to achieve the specified clinical outcome under the VBP arrangement, the drug manufacturer may be required to provide a discount or otherwise may not be entitled to payment for that patient. Thus, the best price of that drug for purposes of the MDRP could become zero. This possibility has stunted the development and proliferation of VBPs. This new proposal from CMS, which includes other regulatory revisions as well (e.g., minimum standards for Drug Utilization Review [DUR] programs), could ultimately lower healthcare costs and potentially limit spending on treatments with limited value over time.

The ultimate goal of a VBP is for all parties to have a vested interest in the outcomes of drug therapy and to share the risk related to healthcare costs. Specifically, it calls on manufacturers to have more “skin in the game.” Moreover, the change to the Medicaid market could have potential savings applicable to a variety of market segments, impacting all Americans. Regardless of the final outcome or any changes made to the current draft prior to its possible rollout, the proposal demonstrates readiness from CMS to pivot prior strategies to mitigate rising drug prices.

As our country continues to navigate the coronavirus pandemic and social distancing, a new concern has emerged – avoiding and delaying medical help when necessary, also known as medical distancing. Maintaining physical and mental health during the current pandemic is essential. If you are feeling ill, need a routine medical check-up, or have severe feelings of anxiety or depression, please seek medical attention.

Stop Medical Distancing 

It’s important that you feel safe and get the care that you need, when you need it. Here are some helpful tips to safely receive medical attention while social distancing:

1.  Mask Up– The Centers for Disease Control and Prevention have asked all Americans to wear a cloth face covering to help prevent the spread of the coronavirus. Medical facilities require patients, staff, and providers to wear a mask to protect you and your community. Take part in the fight against the coronavirus by complying and wearing a mask, too.

2.  Distance Yourself– When you are waiting to be seen by your physician, ask if you can wait outside or in your car. If you have to stay inside, do your best to distance yourself from other patients, visitors, and staff. When returning home, avoid being in the presence of those most vulnerable to coronavirus.

3.  Sanitize– Medical facilities are regularly cleaning waiting areas and exam rooms between each patient. Hand washing and sanitizing your hands before and after your visit is a must to protect yourself and your family from getting sick. Keep hand sanitizer in easy-to-reach places so you don’t forget, such as your bag, purse, pocket, or in your car.

4.  Limit Visitors– To create a safe environment, many medical facilities have implemented restrictions and limitations on visitors. This helps protect you and other patients who are vulnerable to the coronavirus. Going to the doctor alone can be scary and intimidating – but it’s essential to limit friends of family members from going with you when it can be avoided.

5.  Go Digital– If you’re still not comfortable with face-to-face visits or don’t need to be physically seen by a doctor, you should optimize telemedicine or telehealth services. These are appropriate and efficient means of connecting with your provider in the comfort of your own home.

6.   Trust– Finally, trust your doctor and know that your safety is their number one priority. As the pandemic continues, medical facilities are adjusting the way they deliver health and enhancing their procedures and protocols.

Protecting yourself from the coronavirus does not need to get in the way of your overall health and well being. #Stopmedicaldistancing

There are an estimated 1.2 million people in the US living with HIV, and roughly 1 in 8 people are undiagnosed. The virus attacks your body’s immune system and weakens its ability to fight infections. When HIV is untreated, it can lead to acquired immunodeficiency syndrome (AIDS), and the body becomes even more at risk for opportunistic infections.

While antiretroviral therapy has been available to treat HIV-positive patients for some time now, certain antiretroviral medications are also FDA-approved to be taken daily to prevent the risk of becoming infected with HIV. This treatment, known as pre-exposure prophylaxis (PrEP), is intended for people who do not currently have HIV but are at risk for contracting HIV. Overall, PrEP has shown to reduce the risk of contracting HIV through sexual contact and injecting drugs by 99% and 74%.

The main goal of any PrEP treatment is to prevent the transmission of HIV to an uninfected person. There are multiple treatments available to help reduce the risk. Regardless of which medication a patient takes, these medications must be taken consistently every day as prescribed. It is also crucial to not skip or miss doses. Possible side effects from PrEP medications primarily include nausea, but in general, these medications are well-tolerated. Despite this, it is still important to tell a healthcare provider about any side effects experienced.

Advances in antiretroviral treatments have made it possible for patients to live healthy, vibrant lives. That said, patient management programs are very valuable to patients whose ability to take their medications as prescribed has direct impact on the long-term success of their treatment.

This month, we are sharing thoughts and insights on the importance of peer support services in healthcare, as well as other systems where peer supporters can be integrated. As the impact of the COVID-19 pandemic continues to be felt across the U.S. and around the world and folks struggle with the fallout, we are seeing an increased need for mental health and substance use disorder services and supports.

COVID-19 mental health impacts  

For many, the virus has taken a terrible toll. Family and friends have been lost. Millions of jobs have been lost. Our collective and individual sense of what is “normal” has been lost.

In a May 14, 2020 news release, the United Nations called for a substantial investment in mental health services to avoid a “massive increase in mental health conditions in the coming months.”

World Health Organization Director-General Dr. Tedros Adhanom Ghebreyesus said this:

“It is now crystal clear that mental health needs must be treated as a core element of our response to and recovery from the COVID-19 pandemic. This is a collective responsibility of governments and civil society, with the support of the whole United Nations System. A failure to take people’s emotional well-being seriously will lead to long-term social and economic costs to society.”

Focus on prevention

Public health experts, media and a growing number of policy makers are urgently emphasizing the critical necessity to take a preventive approach to this crisis, urging people to wear masks in public, practice physical distancing and increase testing. If we don’t embrace prevention, we will not beat this disease.

It’s not just infectious diseases like COVID-19 that require a robust, full court press preventive public health response. We need to get serious about prevention in mental health. A 2015 research article, Preventing Mental Illness: Closing the Evidence-Practice Gap Through Workforce and Service Planning stated:

Despite advances in treatment, there is little evidence that prevalence rates of mental illness are falling. While the prevention of cardiovascular disease and cancers are common in policy dialogue and service delivery, the prevention of mental illness remains a neglected area.

Note the reference to “evidence-practice gap” in the article title. What does that mean? Here’s a great, succinct description from a 2014 article published in PLOS Medicine.

Health research promises societal benefit by making better health possible. However, there has always been a gap between research findings (what is known) and health care practice (what is done), described as the “evidence-practice” or “know-do” gap.

Peer support contributions

So, what are the implications to the peer support workforce I mentioned at the beginning of this article? How does prevention apply to this discussion? Why is there still an “evidence-practice” gap with regard to peer support?

There are 200+ articles published in the literature on peer support. Peer support has long been recognized as an evidence-based practice. In fact, there are several peer-developed, peer-delivered models grounded firmly in the principles of recovery and resiliency, choice and self-determination, and an understanding of a holistic approach to wellness. And these models have been shown to have a positive impact on traditional outcomes, predominantly measured in behavioral health, including significant reductions in hospital admissions, fewer re-admissions and decreased spending on high-cost, restrictive settings like psychiatric inpatient. While peer support is not a clinical service, it has been shown to impact clinical outcomes. Beyond this, folks receiving peer support services express very high degrees of satisfaction with those services and report improved quality of life.

This is an excerpt from the Magellan Healthcare eMpowered for Wellness July newsletter. To read the full article, go here.

Telehealth services have been available for years to help remove geographical and other boundaries for people in rural and medically under-served areas; however, use has been limited. Driven by the COVID-19 pandemic, including shelter-in-place orders, social distancing, and federal agencies mandating use for certain programs, telehealth has grown exponentially since March.

While companies like Teladoc and MD Live have been operating telehealth platforms for nearly two decades, many platforms are dedicated only to physical health. Magellan Healthcare has maintained a telehealth network for behavioral health since 2014 and helps:

• Health plans offer a cost-effective alternative to traditional doctor visits, urgent care and the emergency room; provide access to valuable care that is convenient and available anytime and anywhere; expand existing programs and services focused on health and wellness; and attract new members by offering the modern convenience of an on-demand service.
• Employers improve employee access to healthcare; reduce tardiness and absenteeism; increase employee productivity; offer a competitive benefits package; improve employee satisfaction; and retain and attract the best employees.
• Members have more privacy; access a deep and specialized network; receive treatment before work, after work or on weekends; have more frequent touch points to improve compliance with treatment and avoid unnecessary hospitalizations; and avoid travel, lost time from work and weeks of waiting for an appointment.
• Providers reach out to members in remote areas or where specialties are needed; provide care to homebound members; provide behavioral health services from home, office or while traveling; reduce no-shows and cancellations; offer additional and/or non-standard appointment times; and expand the patient base and improve relationships with existing patients.

Although the benefits of telehealth are many, people may feel uncomfortable using services. That’s why Magellan Healthcare created a video called Telehealth: Get Care and Treatment Wherever You Are. This video can help people understand:

• How to schedule a telehealth visit
• What to do once a telehealth visit is scheduled
• How to get the most from telehealth

The more comfortable people are using telehealth for their behavioral healthcare, the more options they have available to them. This can lead to improved compliance and better health outcomes.

Watch the video here.

Prescription drug prices can be expensive. How can the average person save money on prescriptions in a quick, easy way? Pharmacy discount cards are available widely, but what are they and why should people use them? Here are five important things to know about pharmacy discount cards.

1. They can save you money!
   Pharmacy discount cards can be used to lower your costs on medications you need to fill that may not be covered by your employer’s health insurance plan. Using a discount card can save up to 80% off the cash price when you need to fill a non-covered drug. Comparing prices between your insurance and discount card is important to make sure you are not overpaying for your prescription. You should also check other pharmacies as prices do vary from chain to chain as well as independent pharmacy locations.

2. Using them won’t count toward insurance plan deductibles.
   Prescriptions filled using a discount card do not count toward your deductible or out-of-pocket maximum amounts. Discount card transactions fall outside of your health plan policy and should be used when a drug is not covered or if you are uninsured. Discount cards cannot be used in combination with insurance.

3. They are free to use.
   Most pharmacy discount cards do not require membership fees to use their cards, but some programs do require you to provide personal information. Make sure you review their privacy policy to ensure you are comfortable sharing information before using their services. The privacy policy is typically posted on their website.
4. No paperwork necessary.
   With pharmacy discount cards, there are no forms to fill out and no paperwork. When you present your discount card at the pharmacy, you are given the discounted prescription price at the counter and you pay the balance. There is no further obligation on your part to the discount card. You can use the card for future transactions, but typically there is no requirement to do so.

5. They work for pets, too!
   If you have pets, many discount cards extend their benefits to them as well. Many people fill their prescriptions at their veterinary office without realizing they may be overpaying. There are some prescriptions for your dog or cat that can only be filled by a vet, but many can be filled by your local pharmacy and usually at a much lower cost. You can ask your vet to write a prescription for your pet and have it filled at your neighborhood pharmacy. Make sure the vet includes their DEA number as most discount cards require this information to process the prescription.

There are many companies offering to save you money on your prescription drugs, which can sound too good to be true. Pharmacy discount card providers are only compensated when you fill a prescription using their card and the pharmacy benefits from your business. You get to save money on your prescription and improve or maintain your health of you or your loved ones.

In contrast to the conventional drug approval pathway in which drugs are reviewed under a New Drug Application (NDA), approval of a biological product is done under a separate pathway known as the Biologics License Application (BLA). Examples of biologics include therapeutic proteins such as insulin, monoclonal antibodies, vaccines, and blood-derived products. While the NDA and BLA processes are similar, they are not identical. The typical generic drug provisions (e.g., same active ingredient, bioequivalence) do not apply to BLAs. Instead, the single biological product already approved by the United States (US) Food and Drug Administration (FDA) is referred to as the reference product; the new potential biosimilar is then compared to the reference product. For approval as a biosimilar, the manufacturer must demonstrate that the agent is highly similar with no clinically meaningful differences.

In July 2018, the FDA released their Biosimilar Action Plan, described by then FDA Commissioner Dr. Scott Gottlieb, as “aimed at promoting competition and affordability.” Then, in December 2018, the FDA announced the plan to transition biological products that were historically regulated as drugs and approved via NDAs to the biologics pathway, taking effect in March 2020. These products include insulin, human growth hormone, and glucagon, among others. This change was mandated by Congress in the 2009 Biologics Price Competition and Innovation Act, which allowed 10 years for the transition. When considered as drugs under the NDA pathway, it was virtually impossible to develop a generic equivalent due to the nature and the inherent variation in the manufacturing process of these products. On March 23, 2020, the FDA issued a statement noting that this change is now in effect.

However, in the US, even if an agent is determined to be biosimilar, it is not automatically interchangeable (a process by which a product can be substituted for another without the approval of the prescriber). For a biosimilar to be considered interchangeable by the FDA, it must meet even more rigorous requirements and be approved as interchangeable. For products that are biosimilar but not interchangeable, the prescriber still needs to write for the specific product. In addition, even if determined to be interchangeable by the FDA, state pharmacy laws may further regulate what substitutions may be made at the pharmacy level without the approval of the prescriber. Just as a listing of generic equivalents is available through the FDA in their Orange Book, the FDA lists biologics and any respective biosimilars in their Purple Book. Recently converted to an online database format, the Purple Book provides details on reference products, their corresponding approved biosimilars, and whether or not the biosimilar is interchangeable. To date, no biosimilar has been designated as interchangeable.

As described in a previous blog post, the cost of insulin has risen substantially, leading patients to take desperate measures. At a time of economic instability and health uncertainty, these access concerns are even larger. Now that these products have transitioned to the biologic approval pathway, once patent exclusivity has passed, biosimilars can be developed, evaluated, and approved. Moreover, biosimilars can be reviewed further and may be classified as interchangeable, which can further alleviate the burden by allowing substitution at the retail level depending on local laws. This landmark change can promote market competition, potentially driving increased availability and decreased cost. The FDA reports that even having one generic drug on the market can decrease prices to approximately two-thirds of the price without competition. Generally, initial list prices of launched biosimilars have been 15% to 35% lower than their reference products. Most importantly, in their announcement of this change on March 23, the FDA pledged that they are ready to review eligible applications to ensure efficient approval. Ultimately, this revised process will provide an opportunity for other manufacturers to introduce safe and effective product competition without clinically meaningful differences. While this may be challenging in light of the ongoing global pandemic, this change, 10 years in the making, offers hope for patients who use these medications.

When your workplace is disrupted by a tragic event, employees may feel overwhelmed, anxious, insecure, and distracted. Everyone reacts differently to stress events, but tragic workplace events are serious and can cause significant physical, cognitive, and emotional reactions. A team of experienced mental health consultants can help reduce the negative impact of the event and its long-term impact on the organization, speed recovery, and return people to everyday life. Critical event interventions can also prevent post-traumatic stress disorder (PTSD).

Types of traumatic events

Tragedies come in many forms. Typical traumatic events include the unexpected death of an employee, a chronic illness of an employee, an injury at work, robberies, shootings and other acts of violence, criminal attacks, industrial or natural disasters, or even organizational restructuring or dismissal. People who have witnessed the event or know the people affected can experience a number of symptoms of the stress response, such as:

• Insomnia, nausea, dizziness, fatigue, racing heart, headache and loss of appetite
• Nightmares, hyper vigilance, panic attacks, intrusive images and poor concentration
• Feelings of anxiety, guilt, depression, irritability, anger and fear
• Social withdrawal and self-medication with alcohol or other drugs [1]

Critical events can also trigger memories of previous intense stressors.

How Magellan’s Employee Assistance Program Can Help

Magellan’s Critical Incident Response (CIR) team consists of specially trained clinical staff who are available 24 hours a day, 365 days a year. CIR Consultants help employees process and manage the emotional and physical effects of a traumatic event.

The first step is to consult with you about what has happened and assess the situation. Once the situation is assessed and an action plan is developed, we will send a CIR consultant to your workplace within a reasonable and agreed time frame. The CIR consultant will carry out a structured intervention on site to help deal with the incident, if necessary, and will also be available to managers and individual employees if needed. Services are confidential and provide employees with the resources and support they need to cope with the stress and anxiety caused by the event and return to normal life.

Our broad spectrum of CIR services includes management consultancy, telephone crisis support, group and individual support for affected employees, as well as follow-up care.

Critical incidents and tragic events occur in all types of companies and industries. Preparation with an existing CIR program is key to effectively managing the aftermath and associated risks.

[1] https: //www.osha.gov / SLTC/emergencypreparedness/guides/critical.html