Author: frierlevitt

Three Reasons State Government Matters to Your Business

state government

State government policy matters to your business. Just paying attention to federal policy will not cover all that your business needs to know in order to avoid possible policy pitfalls. There are three reasons state government matters to your business.

Regulations: States make regulatory decisions every day that could affect your business and how it operates. There could be up to 20 to 30 proposed new regulations a week in any given state. Most state governments work the same way in that they first propose new regulations and publish the proposals for public comment. After the public comment period many states make changes to their proposals or make the proposal permanent. Once a proposal for regulation is permanent your business must start to comply. Some states may propose an emergency regulation that will eventually become permanent without public comments.

States can regulate almost every part of your business from how much you have to pay your employees to what basic training needs to be done in your industry. You must follow these changes in order to avoid fines and other serious consequences that may come from non-compliance. The best place to start is by watching for regulatory changes in the state agency that regulates any licenses that your business may require to operate.

Licences: This brings us to the second reason that state government policy matters to your business. In order to operate as a business in any state you will need a license. You may need multiple licenses based on the type of business you operate. For instance, many business that operate in the healthcare industry may be required to keep at least five licenses up to date from several state agencies. It is important to watch these agencies that control these licenses as they may make changes that could prevent your business from operating in the state.

Taxes: The final reason state policy matters to your business is taxes. Many states these days have overrun their budgets and are running at a deficit. They may choose to make up the difference by placing special taxes on your operation. For instance, some states have proposed gross receipts taxes in the past. Any taxes on your business will have an effect, though if you have a very small margin of profit, a gross receipt tax may affect you in a more negative manner than other businesses. This is why we always recommend that clients watch their state’s budget negotiations every year as this may offer clues as to what the state may tax next.

Regulations, licenses and taxes are some of the most important reasons why state governments matter to your business and its operations. Following all of these policies may be challenging on top of day to day operations. Having a government affairs team may help with these issues. Frier Levitt Government Affairs offers several solutions to help figure out how state policies are affecting your business. One of the best places to start is our Insight Sessions. With just two hours and a memorandum Frier Levitt Government Affairs can explain confusing state policy issues for your team. Contact us today or sign up for more information.

How to Keep Up with Your Legislative and Regulatory Priorities

priorities

Keeping up with all the changes in government policy can be a daunting task even for a seasoned professional. There are federal and state priorities plus any proposed changes that need attention. Not to mention all of the policies that may go unnoticed as they are “recommendations” only. Sometimes with all of the industry chatter it is impossible to know which issues can affect your company and how.

Frier Levitt Government Affairs has created a system that helps our clients keep up with their legislative and regulatory priorities. It is a simple rating system that allows them to track each issue. We rate each issue with a 1-5 system. Rating each client’s priority by a set of proprietary factors allows Frier Levitt Government Affairs to offer each client a “burn factor” for each issue. For example, a client may be watching a specific bill in Congress or a state legislature. As the bill moves forward we tell the client whether the policy is helping or harming them through the rating system. This gives the client a chance to make their own decisions as the bill is moving through the process. Once the rating has reached a 5 it is “burning the client.”

The Burn Factor is based on the client’s specific goals and risk factors. When the client first starts out the rating system is focused on conversations with the client. As time moves on each issue will move up or down in rating based on outside factors such as a legislative vote, regulatory moves or even market indicators. Watching each issue this way gives the client an overview of each priority and the ability to see which issues are actually affecting them. Each rating is specific to the client’s goals giving our clients an edge over the competition. Frier Levitt Government Affairs also adds to the priority list as needed whether by request of the client or if a new policy trend has emerged.

With the Burn Factor our clients rest easy and can focus on actions instead of reacting to policy later when it is too late. Contact us today to learn more.

Doctors in Disaster: Another Use for Telehealth

priorities

The recent hurricanes, Harvey and Irma, have left thousands of people without power, homes, and the necessities of life. Hospitals and doctor’s offices have also experienced devastation with many closing their doors. This leaves patients vulnerable and without proper care.

Recently, several companies have offered a new type of patient care service to those affected by the hurricanes in the form of telehealth. Telehealth allows patients to receive long-distance clinical care as well as health education, and consultations from virtually anywhere an internet or phone connection is present.

The Florida based company MDLive recently offered free telehealth consultations for those affected by the recent storms. Other companies such as DoctorOnDemand, HealthTap, and Teledoc are offering similar services. Telehealth companies aren’t restricted to physical care. Many offer mental health services as well such as American Well, a Boston company, which has offered free telehealth counseling.

The free services from most telehealth companies are on a limited time basis. However, some companies are giving extended free trials specifically for storm victims. LiveHealth will be offering non-emergency telehealth services, including services for mental health, through December 31st. As with most other telehealth services, LiveHealth is available 24/7 at the need and convenience of the patient.

Electricity and internet are still down for many in the storm ridden areas, but luckily most telehealth companies offer cell phone apps that can be accessed if the patient has service and data on their phone.

Cuts, bruises, and common ailments as well as prescription refills and mental health care are some of the more general needs patients seek on telehealth services and considering the widespread damage of the recent hurricanes, telehealth may be the quickest and most efficient way for patients to seek care.

Unfortunately, natural disasters will continue to take place. It seems telehealth companies are realizing how important their services can be in times of turmoil. The next step for these companies will likely consist of expanding the awareness of their existence as well as the services they offer to better assist those in need.

Companies offering discounts and free services are offering further information on their respective websites with details on terms and conditions.

Contact us today to find out more about telehealth.

Pharmacy from the Machine: CVS Launches a New Type of Vending Machine

pharmacy vending machine

America has been called a “fast food society” with a reputation for wanting things quick and easy as if we were driving through our local fast food chain for lunch. However, the desire and focus on achieving healthier lifestyles has also become a topic of discussion in recent years. How does one balance a healthy lifestyle without sacrificing our love for the drive through type of accessibility? CVS believes they have the answer.

CVS recently announced they will be offering retail vending machines that will offer healthy snacks, personal care products, and even health products and over-the-counter medication. The vending machines will offer over 70 different products that will aim to provide a convenient way to purchase popular everyday items.

It is expected the majority of the items featured will be from the CVS brand and CVS family of products, meaning other brands may be left out and thus unavailable for purchase in the vending machine format.

Medication for colds, allergies, coughs, digestive health, and pain relievers will be available for purchase at the touch of a button and without a pharmacist on duty. Unlike a standard CVS or other retail pharmacy facility, the consumer won’t have a pharmacist on duty to inquire about medication questions such as suggested dosage and proper use, potentially dangerous medication interactions, or questions about the ingredients.

Replacing the pharmacist is a touch screen feature that will offer product information. Unfortunately, the touch screen has no way of knowing the individual needs of each person and will be providing preset information that is not specific to the purchaser.

The impact of the CVS vending machine is unclear but it does point to a new avenue in pharmacy sales. For instance, one can imagine the local college student suffering from an afternoon headache and stopping by the CVS vending machine between classes. Will this student understand how to use the medication correctly? Is he taking any other medication that may interact negatively? Will this student be aware of any of the side effects from this medication? Pharmacists by no means guarantee safety in medication use but their presence does offer a way for patients to take their care a step further. Nobody can be certain what the effects of these vending machines will be but their debut will prove to be another step away from traditional pharmacy.

The first 25 CVS vending machines will be dispersed in the northeast throughout October and include places such as parks, airports, and college campuses. Dependent on consumer response, CVS is expected to expand these vending machines to additional locations. For the latest information on policy and market trends, contact us today.

Medicare Part B: The Home Infusion Switch To ASP and What is Next

Part B

At the end of last year there was a significant switch for home infusion from AWP to ASP + 6 in Medicare Part B. This switch happened through the Cures Act which also created a mechanism for a special home infusion service payment. In order to pay for this new payment, CMS urged Congress to change the AWP payment for home infusion drugs to the industry standard of ASP +6. Doing so created smaller payments for home infusion and the switch was effective in 2017. The service payment will not be in effect until 2021. There is legislation currently in Congress that addresses the gap before the service payment is effective.

The House of Representatives has passed the Medicare Part B Improvement Act of 2017 (H.R. 3178) which would create a temporary transitional payment, beginning January 1, 2019, for services related to Medicare Part B Durable Medical Equipment (DME) infusion drugs before a permanent payment structure, that was part of the 21st Century Cures Act, is finalized in 2021. The bill is currently in the Senate.

H.R. 3163, introduced by Health Subcommittee Chairman Pat Tiberi (R-OH) and Rep. Bill Pascrell (D-NJ), creates a transition payment for home infusion therapies for Medicare beneficiaries to ensure there is no gap in care.

It is not clear when this legislation will take the next step forward. CMS may lag behind the 2021 deadline in creating regulations for the service payment. Additionally, Congress may be preoccupied with the debt ceiling debate that could further delay the legislation. If you have questions, contact us today.

The Opioid Crisis: The Benefits of an Emergency

opioids

The Commission on Combating Drug Addiction and the Opioid Crisis has released their recommendations. In their first briefing, they urged President Trump to declare a national public health emergency. The committee created an alarming visual of opioid related deaths, stating 142 Americans die each day which is like having the death toll of September 11th every three weeks.

From 2000-2015 there were over 500,000 drug related deaths with opioids leading in the drug of choice. “The average American would likely be shocked to know that drug overdoses now kill more people than gun homicides and car crashes combined,” the commission reported.

One of the goals of declaring a public emergency would be to create a sense of urgency in not only the government and public but also the health care field. In addition, if an emergency is declared, HIPPA regulations would temporarily relax in order to collect additional data which could lead to further information on opioid trends, user demographics, and ways to help fight the crisis.

The emergency would also allow the government to waive regulation that limits the number of Medicaid and Medicare recipients who can receive residential treatment for their addiction with an additional measure to expand access to medication that helps treat opioid addiction, such as naloxone which is used to reverse overdoses.

The Commission suggested funds for the emergency could be available by enacting the Stafford Disaster Relief and Emergency Assistance Act or the Public Health Service Act, with approximately $1.2 million available through the Disaster Relief Fund and $57,00 from the Public Health Emergency Fund. Whether these assets would be enough to create an impact on opioid abuse would remain to be seen.

The Affordable Care Act (ACA) has expanded treatment to Americans and with Trump adamantly against the ACA and the Better Care Reconciliation Act (BCRA) uncertain there is cause for concern.  An emergency was declared on August 10th by Trump. It will provide avenues for treatment but also create further questions regarding health insurance coverage for those in the private sector and those not covered by Medicaid or Medicare. Regardless, the administration will still need to tackle the issue of treatment coverage, something that has been and continues to be an ongoing issue. For more information, contact us today.

Is Amazon Primed to Disrupt Specialty Pharmacy?

The following is an excerpt from our cover story printed in Specialty Pharmacy Times. Republished with persmission.

Co-Written by Ron Lanton, III, ESQ, Frier Levitt Government Affairs, and Victor Morrison, Next IT Healthcare

July 28, 2017

WHAT IF YOU AWOKE TO THIS HEADLINE? “Amazon Acquires Specialty Pharmacy”

Graduate pharmacy class: circa 2030.

“Good morning, class! Today, we will be doing a case study on specialty pharmacies, starting with their early success introducing a disruptive new service model to accommodate the influx of biologics in the 1990s and early 2000s and then moving on to how, like Kodak, Blockbuster Video, and countless others, they didn’t recognize the implications of emerging digital technologies and were made obsolete by 2025. Let’s get started. Alexa, please project case study 124 onto the center screen.”

This scenario is real, and other industries offer many examples of the dire consequences of digital disruption. With shrinking margins, a dated focus on incremental platform improvements, the increasing desire of consumers for digital self-service, and heavy strategic reliance on human resource–dependent call centers, specialty pharmacies are facing significant and likely fatal disruptions as they enter the crosshairs of technology.

Clinging to a strategy that dictates that high-touch models are the only way to remain viable, most specialty pharmacies have no strategic clarity to support the critical move to digital and mobile health (mHealth) engagement.

A quick survey of the current specialty pharmacy digital landscape indicates that most websites are still glorified business cards and mHealth is the elephant in the room, getting little more than lip service. With a glaring lack of digital engagement options for consumers, specialty pharmacies are still spending significant organizational energy utilizing unscalable call center resources to chase down patients for onboarding, adherence interventions, refills, etc.

Enter Amazon, the most technologically advanced, consumer-centric digital retail distribution organization in the world. With Amazon, you have an entity in prime (pun intended) position to disrupt the specialty and/or retail pharmacy industry.

How difficult would it be for Amazon to buy a small specialty pharmacy licensed in all 50 states and leverage their advanced distribution system and consumer relationship platforms to create an unprecedented ability to deliver specialty pharmacy services and therapies at scale?

Their Alexa, Echo, and Dot conversational user interfaces, synchronized with their ubiquitous Kindle smart devices, could very effectively engage patients, answer questions 24/7, enable the collection of real-time clinical insights, and drive adherence/refills with real-time interventions.

With traditional call center costs dramatically reduced by Amazon’s ability to deliver a pervasive front-end engagement channel for millions of patient relationships by using technology, the ability to compete for payer contracts and deliver more lucrative pharma services at a lower cost would be unprecedented.

By disrupting the current limited-scale high-touch model with an infinitely scalable smart-touch technology-dependent model, Amazon could leverage remote-monintoring devices, artificial intelligence-powered conversational user interfaces, behavior-based real-time virtual coaching, and a low-cost optimized call center to deliver personalized and holistic daily engagement at any point during the patient’s clinical journey at an extremely low price point.

The smart touch approach would trigger a transformative move from traditional call centers that support adherence to a monthly therapy to an unlimited digital engagement platform that will uncover unprecedented real-time data insights and enable optimized adherence to the right therapy.

Biosimilars: Sandoz v. Amgen

biosimilars

Biosimilars, which are “highly similar” to already approved biological products, are becoming more important in the market because they enable patients to access more treatment options, particularly more expensive options, at prices that are more affordable. Obviously, the makers of the brand-name biologics are not in favor of biosimilars of their top-selling products. Recently, however, the Supreme Court of the United States gave biosimilars a win against brand biologics in the case of Sandoz v. Amgen. What does this mean for the specialty pharmacy market?

There are two issues that were answered by the Court in this case, which revolved around Amgen’s approved biologic, Neupogen.

– Did Sandoz, makers of the biosimilar product in question, give proper notice to Amgen of its intent to market a biosimilar of Neupogen?
– Is Amgen entitled to an injunction, stopping Sandoz’s application to the FDA until Sandoz gives Amgen its research and FDA application?

The court’s ruling in this case has now opened the door for biosimilars to enter the market faster, which gives specialty pharmacy patients more options for treatment.

The market for biosimilars was created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which was part of the Affordable Care Act, a.k.a. Obamacare. This act allowed for the creation of biosimilars and created a mechanism within the FDA for their approval. The Court, in Sandoz v. Amgen, looked to the BPCIA in establishing a decision in this case.

Sandoz and its biosimilar clearly won out on the first question. The court stated that the biosimilar manufacturer could simultaneously enter its application to the FDA and give notice of its intent to market to Amgen. This part is the most important part as it allows the biosimilar to reach the market faster. Amgen wanted the court to rule that the FDA application had to be approved before the notice of intent would be allowed. In ruling for the biosimilar, the Court denied Amgen more time to exclusively market Neupogen without biosimilar competition.

On the second question of the injunction, the biosimilar won again because the Court ruled that the question did not need an answer. Amgen had received the application and research information from Sandoz in discovery. Here, the Court intended to be cautious as the BPCIA did not bar the makers of brand-name biologics from obtaining relief in state court, which could have opened the door for more litigation in the states regarding patents for biologics.

These recent decisions have major consequences for the makers of brand biologics, who are trying to protect their patents. With the required notice of intent to market being 180 days, it’s possible that, if the FDA takes 180 days to approve a biosimilar application, the biosimilar can immediately start to market its treatment. This means more options. It also means that, as more biosimilars go to market, the higher the chances that the FDA will approve interchangeability of the various brands’ treatments.

Currently, no biosimilars are considered interchangeable. Also, theoretically, as there are more biosimilars introduced, it is hoped that biological pricing will go down even more. All of this means that there will be greater access to different treatments for specialty pharmacy providers to help their patients. True North offers solutions for healthcare providers who want to stay ahead.

This post can be originally seen on Mediware’s Blog.