There used to be a time when small business could remain on the sidelines while larger entities would engage government officials in order to drive their agendas. However, as the last 10 years have demonstrated, both state government and Congress are now more involved in the marketplace. For this reason, you need to get the government to work for your business.
Landmark laws such as Sarbanes-Oxley, the Dodd-Frank Wall Street Reform and Consumer Protection Act and the Patient Protection and Affordable Care Act have shown that small businesses are now being impacted by government more than ever before.
All small-business owners start with an expectation of expansion amid potential risks. It all starts with a dream followed by a business plan, and then gaining access to credit. While plans progress for a bigger store or for hiring more employees, many owners unfortunately don’t give much thought to how government impacts them. That alone creates a huge risk to growth.
For example, you have spent all this time planning for your new restaurant. However, because you have not been paying attention to the discussions at the state capitol, you didn’t know that a new tax will make it harder to open your business. Fast-forward to your grand opening, and now you have a larger tax bill than expected. You could have prevented, or at least planned for, this development. While it is hard enough to make your product or sell your service, there is some degree of certainty as to what your projected costs will be. Trying to project government’s next step is a lot harder.
I understand why a small-business owner may be hesitant to think about these issues. The political climate has gotten tougher as both sides of the aisle have dug in to their beliefs without as much compromise. While today’s media may have you believe that government is dysfunctional, I am confident that will improve over time. Regardless of today’s divisive partisanship, government is still open for business, and laws are still being passed. I guarantee that there is a law out there that has recently passed at either the state or federal level that will have some impact on your business.
Make connections
So how do you ensure that you can run your business efficiently and have an impact on your government? How do you get the government to work for your business?
First, stop believing that your business is too small in order to get a meeting with a politician. In Congress, you don’t need to speak directly to the legislator- his or her staff will do just fine. Most of the time staffers advise the legislator, and if you can make a good connection with them you’ve won half the battle. New Hampshire is unique because you can call legislators directly and speak them about your issue. It gives you a more personalized feel.
Second, you should find out what is going on. Most chambers of commerce have a government affairs professional on staff that can alert you to trends concerning small businesses.
Now that you know the issues and have spoken to your representative, how do you make sure that your concerns have been heard? Well, if after all of these steps you either still haven’t seen your issues addressed or you have an idea to change a law to improve your margins, you may want to consider finding a dedicated government affairs professional that will advocate for you.
Now you may be asking, “Why can’t I simply do this myself? Wouldn’t it be cheaper?” Think of engaging a government affairs professional as an investment. It is always worth being prepared for government activity with an experienced professional than having potential legislation erase your profit and dream completely.
The best government affairs professional should be able to evaluate your business, create both a short- and long-term strategy and be in constant communication with you to ensure that your profits are being protected. Contact Frier Levitt Government Affairs today for more information.
Mobile health is an emerging area where we hear about the increasing possibilities of reducing costs and achieving greater patient engagement. Right now, there are over 97,000 health and wellness mHealth apps, as the projected revenue for mHealth in 2017 is $26 billion. Additionally, 93% of physicians believe mHealth apps can improve patient health. However, with fitness apps, electronic health records and the of greater utilization of telemedicine, the question that many are asking is what is mobile health?
To date, there is no standardized definition of mobile health or mHealth as its generally referred to. Organizations like the World Health Organization (WHO) has previously referenced mHealth “as an area of electronic health and it is the provision of health services and information via mobile technologies such as mobile phones and Personal Digital Assistants,” while the NIH Consensus Group referred to mHealth as “the use of mobile and wireless devices to improve health outcomes, healthcare services and health research.”” Having no clear definition usually creates a wild west regulatory scheme.
Currently mobile health is overseen by three regulatory agencies:
FDA: The FDA’s position on mobile health is that is it “taking a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of ‘device’ and that: are intended to be used as an accessory to a regulated medical devices, or transform a mobile platform into a regulated medical device. For many mobile apps that meet the regulatory definition of a ‘device’ but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretions and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. The FDA’s mobile medical apps policy does not regulate the sale or general consumer use of smartphones or tablets.”
FCC: “The Federal Communications Commission (FCC) regulates interstate and international communications by radio, television, wire, satellite and cable. The agency’s jurisdiction extends to non-Federal users of spectrum in the 50 states, the District of Columbia and U.S. possessions. The FCC manages Radio Frequency (RF) communications to ensure that RF devices operate efficiently and without interference. In the healthcare area, the FCC authorizes a wide variety of RF-based medical devices including both implanted devices and patient monitoring devices. It also authorizes carriers whose networks are used by a wide variety of mobile devices to access, store or transmit health information, and it establishes technical rules used by Wi-Fi and other similar networks.”
FTC: The Federal Trade Commission (FTC) protects consumers from fraudulent, unfair or deceptive acts or business practices. “The Federal Trade Commission has created a new web based tool for developers of health related mobile apps, which is designed to help the developers understand what federal laws and regulations might apply to their apps. The FTC developed the tool in conjunction with the Department of Health and Human Services’ Office of National Coordinator for Health Information Technology (ONC), Office for Civil Rights (OCR) and the Food and Drug Administration (FDA).
The guidance tool asks developers a series of high-level questions about the nature of their app, including about its function, the data it collects, and the services it provides to users. Based on the developer’s answers to those questions, the guidance will point the app developer toward detailed information about certain federal laws that might apply to the app. These include the FTC Act, the FTC’s Health Breach Notification Rule, the Health Insurance Portability and Accountability Act (HIPAA) and the Federal Food, Drug and Cosmetics Act (FD&C Act).
The guidance, which is maintained on the FTC’s website, links directly to each agency’s information about applicable laws. In addition, the FTC simultaneously released its own best practices guidance for compliance with the FTC Act, by building privacy and security into their apps.”
Where mHealth is concerned, it has focused on the claims companies have made about the effectiveness of their devices or apps. In late 2015 the FTC showed it becoming more aggressive in its oversight of mobile health that may cause confusion on who the lead regulator is in this field. The FTC settled with a California based app developer named Carrot Neurotechnology for $150,000. The company pledged that their Ultimeyes app improved visual acuity, but the FTC stated that the company’s “promoters did not have the scientific evidence to support their claims that the app could improve users’ vision. Health-related apps can offer benefits to consumers, but the FTC will not hesitate to act when health-related claims are not based on sound science.”
Why the FTC? This shows how there is a “wild west environment” that exists with no lead regulatory agency. There are many questions around why the FDA has remained silent. Some theories are that the FDA’s current regulatory structure has not caught up with a 21st century issue such as mobile health. Additionally, the FDA may not want to give the perception that it could stifle innovation. Whatever the case, we could get further clarity on who regulates mobile health with a new Administration.
On the legislative policy front Congress currently has a few bills on point.
S. 1101 titled the Medical Electronic Data Technology Enhancement for Consumers’ Health Act or the MEDTECH Act wants to exempt certain software that promotes healthy lifestyles from being classified as a medical device subject to FDA oversight.
H.R. 2396 titled the SOFTWARE Act sponsored by Congresswoman Blackburn (R-TN) is now part of the 21st Century CURES legislation. This bill seeks to define health software as software that does not acquire, process, or analyze data from an in vitro diagnostic device or signal acquisition system, is not an accessory or part of a medical device, is not used to prevent disease in the transfusion of blood and blood components. Health software is exempted from FDA oversight except for software that provides patient-specific recommendations and poses a significant risk to patient safety.
H.R. 5906 titled the Wi-Fi Capable Mobile Devices Act of 2016 directs the FCC to issue rules to ensure that providers of mobile broadband Internet access service supported through the Lifeline Assistance Program offer mobile devices that are capable of: (1) receiving Wi-Fi or other wireless broadband signals using unlicensed spectrum, and (2) sharing a mobile service connection with other compatible hardware or devices.
So, is mHealth something that specialty pharmacy can take advantage of? I believe so. First it would be best to be aware of some of the emerging mHealth technology to tell your patients as some approved products can have an immediate impact on their outcomes. For example, the Mount Sinai Health System in New York has launched an enterprise-wide platform for doctors to prescribe mobile health apps directly to patients. The platform called RxUniverse features a curated list of apps – pulled from the thousands of health apps available to consumers today – that have already been evaluated for their efficacy based on published literature. Israel-based medical device maker TytoCare has received FDA 510(k) clearance for its digital stethoscope, which pairs with a smartphone and allows users to examine the ears, throat, skin, heart, lungs and temperature. Data will be captured, stored and shared via a cloud-based telehealth platform with video conferencing. Examinations can be done in real time or in advance of a telehealth visit.
A second suggestion is to be aware of the continued emergence of telemedicine. Telemedicine is an area that has been grouped in with mobile health and has shown strong signs of momentum on both the state and federal level as policymakers recognize that telemedicine will help rural patients achieve greater access. Besides expanding the benefits of telemedicine to patients outside of rural areas and the eventual sorting out of licensure concerns, the only major roadblock that exists here is how are providers that engage in telemedicine going to be reimbursed?
Lastly, mobile health can help specialty pharmacies increase medication adherence. Per the Network for Excellence in Health Innovation, medication non-adherence costs our system $290 billion annually. We have seen patients today that are not only more tech savvy in that they own smartphones, tablets and other connected devices, but these patients are the more engaged than ever in trying to improve their own outcomes. By developing or utilizing apps, adherence tools or how to videos, you can help your patients achieve their personal goals but they key is to make sure that these digital resources are simple to use and provides the necessary incentives to keep your patients engaged long term. Contact us today for more information.
According to the Centers for Medicare and Medicaid Innovation (CMS Innovation Center) “cancer diagnoses comprise some of the most common and devastating diseases in the United States: more than 1.6 million people and diagnosed with cancer each year in this country.” Of this statistic, the American Cancer Society estimates 595,690 will die this year. While these trends show us that more work is needed to improve patient outcomes in this disease state, it is encouraging to see increased conversations in both the news and policy realm about the need to confront this challenge and arrive at a positive solution. In recognizing the Specialty Pharmacy Times’ annual oncology edition, I thought it would be appropriate to examine three of the latest policy conversations involving oncology.
The first conversation involves cost containment. CMS surprised the industry with its March announcement of its Medicare Part B Payment Model otherwise known as the Part B demo. In this demo, CMS proposed a “two phase model that would test whether alternative drug payment designs will lead to a reduction in Medicare expenditures, while preserving or enhancing the quality of care provided to Medicare beneficiaries. The first phase would involve changing the 6 percent add-on to Average Sales Price (ASP) that we use to make drug payments under Part B to 2.5 percent plus a flat fee. The second phase would implement value based purchasing tools similar to those employed by commercial health plans, pharmacy benefit managers, hospitals and other entities that manage health benefits and drug utilization.” Physicians in phase 1 will be placed in groups based on their zip codes and will receive a flat fee of $16.80. Phase 2 is expected to limit a patient’s out of pocket cost sharing; however; details on this needs to be expanded on. If finalized, the model is expected to last five years.
The demo was a result of discussions that stemmed from the Medicare Payment Advisory Commission’s (MedPAC) investigation into physician reimbursement for oncology drugs. The Commission who is a nonpartisan legislative agency that provides Congress with policy recommendations on Medicare examined the ASP plus 6% model and were skeptical as they believed physicians could make more money by administering the more expensive product that may or may not have an improved effect on the patient’s outcome over the lower-priced drug.
While many groups have come out in opposition to the demo, Avalere has published a report that finds that the proposed Medicare payment changes for physician-administered drugs would reduce reimbursement for those that cost more than $480 per day in 2016. The analysis also shows that seven of the 10 drugs that constitute the largest reduction in reimbursement are used to treat cancer. Meanwhile, some primary care physicians, who tend to use lower cost drugs, would be paid more. At this point, it is unclear whether prescribers will be incentivized to fall in line with the goals of the demoand how this CMS proposal will coincide with the agency’s own five-year Oncology Care Model that will invest in physician-led practices who care for patients receiving chemotherapy.
The second policy conversation centers on the impact of waste. According to a March 2016 study titled Overspending driven by oversized single dose vials of cancer drugs, researchers at Memorial Sloan Kettering Cancer Center estimate that there is nearly $3 billion in wasted oncology medications. The study which analyzed the profits of drug manufacturers, oncology physicians and hospitals, examined the top 20 drugs for multiple cancer types packaged in single dose vials and for which the dose is dependent on the patient’s weight. “Based on the available vial sizes in the U.S., the researchers estimated that makers of those 20 drugs this year will receive an extra $1.84 billion from charges for unused medicine, or about 10 percent of their expected U.S. sales. Insurers and cancer patients will pay at least another $1 billion on unused medicine in 2016, based on the markups hospitals and doctors charge over a vial’s price every time they infuse patients with those cancer drugs, the researchers concluded.” The problem lies in the packages oftentimes containing more medication than patients need. While the obvious call to many is to require manufacturers to produce cancer drugs in different vial sizes, policy concerns such as scheduling for distribution to patients, as well as storage and handling requirements for oncology drugs that are biologics (products engineered from living cells compared to a chemically composed pills) remain.
The aforementioned report did not go unnoticed in the policy realm. Shortly after the release of the report, Senators Amy Klobuchar (D-MN) and Jeanne Shaheen (D-NH) wrote a letter to Food and Drug (FDA) Commissioner Dr. Robert Califf urging the FDA to examine the dosage size of cancer drugs. On the state level, while several state legislatures have for years attempted to create drug return, reuse and recycling laws, Washington state this spring has enacted legislation which seems to find a workable solution to cancer drug waste. HB 2458 was recently enacted and effective January 1, 2017, will allow cancer patients to donate their unused drugs to people in need that may not be able to financially afford it. The legislation could simultaneously reduce costs and improve patient outcomes.
The last policy conversation centers on one of many innovative policy solutions. Vice President Joe Biden (D-DE) has been personally invested in finding a cure for cancer as during recent budget negotiations, he lobbied for an increase in appropriations in cancer research funding as part of his pledge to find a “moonshot” to end cancer. During President Obama’s last State of the Union address, the President officially tasked the Vice President with overseeing his moonshot goal. With his last year in office as Vice President, Mr. Biden will be working to find federal funding to help in gene sequencing as well as trying to develop a data sharing program for researchers to communicate on different therapies.
Moonshot 2020 whose official name is the National Immunotherapy Coalition is a coalition being led by Patrick Soon-Shiong who is bringing together academia, insurers and competing drug and biotech manufacturers together to combine several immunotherapy treatments to overwhelm cancer cells rather than having these companies work in isolation. The plan is to make 60 novel and approved cancer therapies and enable rapid testing of new combination protocols.
According to the Coalition, the initiative aims to explore a new paradigm in cancer care by initiating randomized Phase II trials in patients at all stages in 20 tumor types in 20,000 patients within the next 36 months. All 20,000 patients will have their tumors genetically sequenced, and the plan is to create a patient registry where drug makers can search for specific patients that fit their trial criteria. These findings will inform Phase III trials and the aspirational moonshot to develop an effective vaccine-based immunotherapy to combat cancer by 2020.
In conclusion, these aforementioned policy discussions are a sample of many that are occurring in the United States as we look for out of the box thinking to confront the growing challenges within oncology. The road ahead is never smooth, but I like many take solace in the fact that the answer lies in the continued and tireless cooperation of government, academia and private enterprise. Contact us for more information.
The biggest problem the United States healthcare system faces is preventable disease. We don’t have enough doctors, nurses, and health coaches to fix it. Yes, we have a doctor and nurse shortage. But the larger issue is that the treatment or prevention of these types of diseases requires significant behavior and lifestyle changes, which are achieved through extensive coaching, carefully timed intervention, and constant monitoring – all very hands-on, human activities. Even the best, most attentive healthcare providers simply can’t be there for a patient around the clock to catch every bad habit or reinforce every positive behavior.
Many make the argument that we need to increase federal funds and train more nurses, license more physicians, and/or deploy more health coaches. Yes, we need to do these things, but it’s not going to be enough, and increasingly people are becoming more comfortable interacting with machines than they are with humans. Traditional approaches, even if they are wildly successful, only ensure that more people get to see their doctor in a timely fashion. They don’t do anything to help doctors spend more time with each patient. It’s time to turn to technology to help us do what it does best – scale.
Artificial Intelligence (AI) has evolved to the point that it can significantly augment the work done by physicians, pharmacists, and health coaches. AI-powered technologies can fill in the gaps between appointments by reminding patients to take their medications according to their schedule, influencing and rewarding behavior change at exactly the right moment, and even intervening when something in the treatment plan is off. AI is capable of learning and growing with a patient too, so it can adapt and adjust based on the patient’s individual needs, schedule, and disease.
The preventable disease problem we’re facing in healthcare today can be solved by a deepening relationship between humans and AI.
If this sounds futuristic, it is… sort of. The technology already exists and is deployed in other arenas like finance and business intelligence. But in healthcare, there’s a human and psychological barrier – can we trust AI with our health? Our health data?
In a recent study conducted by Next IT Healthcare and Kaiser Permanente, researchers found that patients are increasingly comfortable with and trusting of AI-driven virtual health coaches. In fact, many patients who interacted with artificial intelligence-driven technology in a doctor’s office were inclined to disclose more information than they would otherwise tell their doctors.
What does this new human-to-machine bond make possible for our healthcare system? The implications for healthcare are profound.
Better data. When patients interact with a virtual health coach on their phone, desktop or tablet, human caregivers get new context that has heretofore been very difficult to obtain, particularly in real-time. Virtual health coaches are perhaps the best collection mechanism for data addressing patient medication questions, treatment plan adherence, and accessing how patients are feeling day to day. Consider what happens when we can correlate this data with other patient-generated data, like that from wearables, home monitors, scales, and environmental sensors.
Healthcare providers can use this data to better understand when to intervene, to predict and prevent relapses, and to create a custom treatment plan specific to a patient’s routine that also evolves with the patient. The value of high-fidelity and real-time patient generated data is immense and will be transformative.
System-wide cost benefits. 24/7 access to what is essentially a nurse-less hotline can reduce the burden on doctors and other care providers. They can ensure that when human interactions are needed, they are as impactful as possible.
Imagine a patient needs help understanding the side effects of a drug she is taking. A virtual health coach can walk a patient through the known side effects and identify if the patient is experiencing any of those effects. If she is, the virtual health coach can determine the severity of the side effects by asking a series of questions. The technology can then triage and rout the resulting information to a live healthcare provider, who can intervene immediately if needed, and help the patient determine if she needs a trip to the emergency room, or can treat the symptoms at home.
Early detection prevents potentially costly complications while patients would otherwise be waiting for an office visit. But the technology can also reduce the occurrence of unnecessary office visits. Whether there’s a problem or not, this technology can drive efficiency.
Personalized treatment. “Doctor’s orders,” treatment plans and standards of care are rooted in sound science and studies involving hundreds and thousands of subjects, but are rarely tailored to the individual – eat vegetables 3-4 times a day, exercise 3-5 days a week, take your pills twice a day for 2 weeks. Yet adherence to these kinds of recommendations is dismal because there is no guidance on how a patient can achieve those goals and why, particularly given their existing lifestyle and behaviors.
A virtual health assistant is able to spend more time with patients than even the best and most attentive healthcare providers, and using motivational interviewing it can collect valuable information and insights passively and proactively. It can therefore learn a patient’s preferences, habits, and routines, and adapt treatment plans to match.
For example, instead of prescribing a medication and saying a patient needs to take it twice a day, 12 hours apart with food, a virtual health coach can learn when you generally eat breakfast and dinner, and when you wake up and go to bed and help you determine a specific schedule that fits your lifestyle and improves the outcome.
Regulation & Policy Implications
The human benefits that virtual health assistants can bestow on the patient population are clear. But are there relevant policy issues that VHAs can help address too? First it should come as no surprise that the debate around healthcare has centered on its fiscal impact. For example:
According to the Centers for Disease Control and Prevention, the World Health Organization has estimated that by 2020 the number of Americans affected by at least one chronic condition requiring medication therapy will grow to 157 million. Additionally, the direct economic cost associated with non-adherence to medication is estimated at $100 billion to $289 billion.
Chronic diseases are responsible for 7 of 10 deaths each year, and treating people with chronic disease accounts for 86% of our nation’s healthcare costs.
From 2015-2025, health spending is projected to grow at an average rate of 5.8% per year and will grow 1.3 percentage points faster than the Gross Domestic Product per year over this period.
Only recently have policymakers begun to examine the benefits of how integrating healthcare professional services can create an improved outlook on cost containment and patient outcomes.
Prior to the enactment of the Affordable Care Act (ACA), patients would receive siloed treatment as there would be no coordination of care for a patient that transitioned from acute to post-acute care settings. It is during this vital time that patient questions go unanswered and the risk of non-adherence rises thus driving up healthcare cost. However; to tackle this problem, the ACA has created alternative payment models such as bundled payments that are forcing providers to share more risks in an effort to receive a greater piece of now “shared” reimbursement. Now providers must work together to demonstrate how they have affected a patient’s positive outcome and thus created value for the healthcare system. The best way to do this is through data sharing. That is one area where virtual health coaches have the greatest opportunity.
The origins of data sharing as a way to tame healthcare spending can be seen through the enactment of the Health Information Technology for Economic and Clinical Health (HITECH) Act. The law’s enactment in 2009 along with the solidification of the importance of electronic health records in the ACA, set the stage for physicians and hospital providers to receive a reimbursement incentive from the Centers for Medicare and Medicaid Services (CMS) for those who are successful in becoming “meaningful users” of electronic health records. If providers have not found a way to do this by 2015, they would soon find themselves subjected to penalties under Medicare.
As providers continue to struggle with how to implement electronic health records into their practices, perhaps they are overlooking the simplicity of AI-powered solutions. More than ever consumers are becoming more involved with maintaining a healthy lifestyle using technology such as fitness apps and telehealth. Interestingly, about 35% of U.S. adults say they have used the Internet to figure out what medical condition they or someone else might have, demonstrating a need for on-demand convenience. Utilizing a virtual health coach can not only give healthcare providers a better look into what works for a patient, but also satisfies policymaker goals. First, healthcare costs can be reduced since a virtual health coach serves as another powerful tool a provider can use in monitoring a patient; records created by the VHA could be shown by the provider community that they are meeting the “meaningful use” requirements set the by HITECH Act, and by putting patients in control of their own outcomes by utilizing a tool that can adapt to their lifestyle would more likely than not create a potent recipe for cost containment success.
Integrating AI into everyday chronic disease management has the potential to solve some of the most burdensome problems facing the U.S. healthcare system. AI-powered solutions improve engagement with patients, earn their trust in the process, and offer a comprehensive holistic one-stop-shop ecosystem from which the patient can manage their health, something the previous generation of health technologies could not accomplish. The human-to-machine bond makes it possible for this new generation of technologies to directly address rising costs while improving quality of life and patient outcomes.
Though we’re still in the early stages, and we certainly don’t have all of the answers, we need to pursue this area of innovation with urgency. Imagine a healthcare system aided by artificial intelligence that is a trusted partner in a patient’s lifelong healthcare journey.
That day, we believe, is just around the corner. Contact us for more information.
