Investigational medicines are drugs or treatments not approved by the U.S. Food and Drug Administration (FDA) for use in the general population. For many patients, especially those with serious illnesses or conditions, these investigational medicines can offer hope when other treatments have failed or are unavailable. However, navigating the process of requesting an investigational medicine can be complicated and intimidating, but it doesn’t have to be. Here is a step-by-step guide to help you understand what you need to know before submitting an application for an investigational medicine.
Understand Your Rights as a Patient
According to the FDA, every patient has the right to access experimental treatments if they meet certain criteria and their doctor agrees it is appropriate for them. It is important to note that while your doctor may agree that an investigational medicine may benefit you, they may not be able to get it approved by the FDA or insurance company due to medical necessity criteria or budget constraints. As such, you need to understand your options before deciding whether or not to pursue investigational medicines.
Research Clinical Trials and Compassionate Use Programs
The most important step is to research clinical trials and compassionate use programs that might be available to you. Many websites, such as ClinicalTrials.gov or Drugs@FDA, provide information on current and upcoming clinical trials related to your condition. If you qualify for a clinical trial, contact the study coordinator on the website to inquire further.
Suppose there are no suitable clinical trials available. In that case, you should explore compassionate use programs offered by pharmaceutical companies or doctors approved by the FDA to give expanded access to drugs outside of clinical trials. Contacting these entities directly is often necessary to gain access if no other options are available.
By Isaac Smith, healthcare content strategist, Medcare MSO.
If you are involved in the healthcare industry, you must be familiar with the terms “ASC Coding and Billing” and “Physician Medical Billing.” These two concepts are important to understand if you are a healthcare provider or if you run a healthcare facility. In this article, we will discuss the differences between ASC Coding and Billing and Physician Medical Billing.
Medical billing and coding are critical components of the healthcare industry. They are the processes that ensure that healthcare providers get paid for their services. Medical billing and coding can be complex and challenging, especially if you are not familiar with the terminologies involved. In this article, we will simplify the concepts of ASC Coding and Billing and Physician Medical Billing.
Starting January 1, 2008, the CMS publishes annual updates to the list of procedures an ASC can be paid for. To establish payment indicators and rates for newly created Level II HCPCS and Category III CPT Codes, CMS updates the lists of covered surgical procedures and ancillary services quarterly. ASC billing and coding are explained below.
On the CMS website, you can find the complete lists of ASC-covered surgical procedures and ancillary services, the applicable payment indicators, payment rates before regional wage adjustments, wage-adjusted payment rates, and wage indices.
ASC certification and a CMS agreement are required for this provision. ASCs must accept Medicare’s full payment for ASC services. Physicians and anesthesiologists can bill and be paid for professional services.
Lab services and non-implantable DME can be billed using the correct certified provider/supplier UPIN/NPI. The basics of ambulatory surgery center billing are simple, but physician and facility requirements differ. Physician and facility billing are different from ASC billing. ASC billing and coding don’t focus on a medical specialty like physician medical billing, which must follow a few highly specialized guidelines to get reimbursed.
ASC Coding and Billing
ASC stands for Ambulatory Surgical Center. An ASC is a healthcare facility where surgeries that do not require an overnight stay are performed. ASCs are becoming increasingly popular because they are less expensive and more convenient than traditional hospital settings. ASCs have their own set of codes and regulations that are different from those of physician medical billing.
ASCs are reimbursed for their services based on a fee schedule set by Medicare. The fee schedule is based on the geographic location of the ASC, and the complexity of the surgical procedure. The fee schedule is also updated annually to reflect changes in the costs of providing healthcare services.
ASCs have their own set of codes that are used to bill for their services. These codes are different from those used in physician medical billing. ASC codes are more specific and detailed, as they are designed to describe the unique services provided in the ASC setting.
Running a healthcare facility, whether a hospital, clinic, or medical practice, requires efficient management to ensure the highest level of patient care while controlling costs. In today’s fast-paced healthcare industry, healthcare leaders face unique challenges that can impact the efficiency and effectiveness of their facilities.
Therefore, this blog explores practical tips to help healthcare facility managers streamline operations, optimize workflows, and enhance patient outcomes. Whether you are a seasoned healthcare professional or new to the industry, these tips will provide valuable insights on running a healthcare facility efficiently.
1) Focus on Staff Development
Providing ongoing training and development opportunities for staff is essential to ensure that they have the knowledge, skills, and ability to deliver quality care. Staff development programs can increase staff engagement, job satisfaction, and retention rates, improving patient outcomes and reducing recruitment and turnover costs.
You should also deliver staff development programs such as the following.
Cross-training can be particularly effective in healthcare, as it allows staff to develop new skills and work in different areas of the facility.
Leadership training is also essential, as it can help to develop strong, influential leaders who can motivate staff, improve processes, and drive innovation.
Continuing education is critical to ensure that staff stays updated on the latest trends and best practices.
Mentorship programs can provide staff guidance, support, and career advancement opportunities.
2) Use Technology
One of the most significant technological advancements in healthcare is healthcare artificial intelligence (AI), which has proved to be a powerful tool in improving patient outcomes and reducing costs.
There are several ways to use healthcare AI to improve the efficiency of healthcare facilities, as listed below.
Implementing electronic health records (EHRs) allows healthcare providers to access patient information quickly and easily, reducing the need for manual data entry and paper-based records. EHRs also enable providers to track patient progress, monitor medication adherence, and identify potential health risks.
Telemedicine allows patients to receive care remotely via video conferencing, chatbots, or other digital platforms. Telemedicine is particularly useful in rural areas or for patients with mobility issues, reducing the need for travel and wait times.
Machine learning algorithms can analyze large datasets to identify patterns and correlations that humans may miss, leading to an earlier and more accurate diagnosis. AI-powered diagnostic tools are already used for conditions such as skin cancer, retinopathy, and pneumonia.
Wearable devices and remote monitoring systems can continuously monitor vital signs and other health metrics, alerting healthcare providers to potential issues before they become serious.
3) Establish Clear Communication
Effective communication channels among staff, patients, and their families to ensure everyone is informed and up-to-date. With clear communication, patients can be more involved in their care, staff can work together more effectively, and potential issues can be addressed before they become significant problems. You can foster clear communication through regular meetings, training, messaging systems, and other communication tools.
4) Monitor Performance
Monitoring performance is vital to measure key performance indicators (KPIs) such as patient satisfaction, wait times, and staff turnover to identify problem areas and track progress over time. Regularly monitoring these KPIs will help healthcare facility managers make informed decisions and take necessary actions to improve the quality of care provided.
You must also set achievable performance targets and align them with the overall mission and goals of the facility. You can track these targets with a dashboard or scorecard to visually represent the facility’s performance in different areas.
Comparing your facility’s performance with others can also provide valuable insights into best practices and areas for improvement.
Staff should also be involved in the performance monitoring process by providing regular feedback and suggestions for improvement. This step can create a continuous culture of improvement and accountability, leading to better patient outcomes and higher staff morale.
5) Manage Finances
Financial management can help healthcare providers streamline operations, improve patient care, and maintain profitability. Below are a few tips for managing finances in a healthcare facility.
Develop a budget and stick to it. So, forecast expenses and revenues and identify areas where you can reduce costs.
Negotiate with vendors and suppliers to obtain the best prices for equipment and supplies and explore bulk discounts.
Healthcare providers should establish effective revenue cycle management (RCM) processes to ensure timely and accurate billing and collections. RCM involves monitoring key performance indicators such as days in accounts receivable, denial rates, and net collections and implementing strategies to improve these metrics.
Healthcare providers should regularly review their financial performance and adjust their strategies accordingly. Thus, you must analyze financial statements and reports, identify trends and patterns, and develop action plans to address any issues.
6) Implement Infection Prevention Aand Control Measures
Infections acquired in healthcare settings can have severe consequences for patients, including prolonged hospital stays, increased morbidity and mortality, and increased healthcare costs. Below are some effective infection prevention and control measures.
Promote proper hand hygiene through education, and provide hand sanitizers and hand washing stations.
You can improve environmental cleaning and disinfection by using effective cleaning agents, standardized cleaning protocols, and routine auditing.
The appropriate use of PPE, such as gloves, masks, and gowns, can be reinforced through education and training programs, and by ensuring that PPE is readily available and properly fitted for staff.
Conclusion
Running a healthcare facility efficiently requires careful planning, effective communication, and a commitment to continuous improvement. By implementing the tips discussed in this article, healthcare providers can improve patient outcomes, reduce costs, and stay competitive in a rapidly changing industry. Ultimately, success in healthcare requires a dedication to excellence, a willingness to adapt to new challenges, and a steadfast commitment to providing high-quality care to those who need it most.
My father was diagnosed with diabetes when he was very young and lived his entire life maneuvering various healthcare systems. He had multiple eye surgeries, which is common for diabetes patients. He had pancreatic issues, open heart surgery, and two kidney transplants. It was a lot and, as his daughter, one of the most difficult parts of it all was watching my mother be his primary caregiver, managing doctor appointments, medication prescriptions, treatment plans and insurance claims.
At the time, there was little to no technology on the practice management side of healthcare. Until the internet connected us all, EHR systems were contained to inpatient and outpatient facilities, primarily used as data interchange platforms for claims processing with scanning capabilities to create images of documents. I remember my mother carrying a binder from doctor’s office to doctor’s office – the most effective way for her to keep an easily accessible list of my father’s ailments, healthcare conditions, medications, and all the other details needed by the countless doctors across my father’s continuum of care.
How AI is creating more meaningful patient experiences
Fast-forward two decades and we’re now in an entirely new reality with an ever-expanding healthcare technology ecosystem. Medical office software platforms do so much more than claims processing and digital document storage. Interoperable EHR systems let physicians share treatment plans and easily access medical histories and lab results anywhere and anytime. Patients can schedule appointments online and login to patient portals to get test results in real time. Telehealth has ushered in brand new healthcare delivery models and helped drive greater adoption of behavioral health services. Remote patient monitoring (RPM) technologies have been a game-changer for so many, helping patients better manage chronic illnesses.
And now, with the integration of artificial intelligence (AI), we’re seeing the next wave of healthtech – an advancement that is bringing our entire industry closer to the promise of fully connected or interoperable healthcare systems. AI is having a massive impact on medical practice workflow processes, empowering healthcare providers and medical office staff. AI applications are making it possible to automate tedious and redundant tasks so that medical professionals can focus their time on valuable work that greatly improves the patient experience and outcomes – and that’s just on the business side of things.
The healthcare sector is predicated on protecting all sensitive information for a practice and its patients. Threats come from every direction, whether through email, an attachment, a malicious link, or simply the penetration of a security system.
Solutions are aplenty but with various degrees of effectiveness and durability, not to mention complexity and quality of protection for the practice, all are important factors when measuring benefits versus risk. As healthcare practice leaders attempt to mitigate their continuous onslaughts of threats, possible breaches, and potential bad actors, automating security measures can alleviate trouble, distractions, and chaos caused by a breach or other malicious activity.
While most in healthcare don’t like to discuss the ugly but open secret, email is a significant factor in many data breaches. Therefore, advanced levels of protection for Outlook and other email servers are essential, and add-on solutions solve the problem of misaddressed emails and prevent data leakage.
Technology that scans for sensitive keywords, personally identifiable information (PII), or data patterns inside the email body or attachments can provide practices with a critical layer of security.
Confirm External Recipients and Attachments
Using data loss awareness (DLA) technology, users can confirm the practice’s external recipients (those receiving a message from the practice) before messages are sent. Such an integrated solution “asks” whether everyone on an email recipient list should be seeing the sensitive information contained, so the message is not sent to someone by mistake. Likewise, this prevents misaddressed emails or inadvertent auto-fill email mistakes.
Email breaches from accidental data loss can result in fines, regulatory non-compliance notices, and even litigation for a medical practice. Additionally, medical practices can (and should) seek solutions that proactively help users to prevent accidental data loss and keeps all sensitive information from leaving the organization
In such environments, all settings should be configurable and specified on a per-user or per-group basis. In addition, healthcare organizations should automate activity logs for all potential occurrences with a complete audit trail stored locally or centrally and supporting Outlook local languages, as these are often needed should you be audited.
It’s the 21st century, and 78% of hospitals still “often or sometimes” receive their medical records via mail or fax, according to a 2021 report from the Office of the National Coordinator for Health Information Technology.
This isn’t just an inconvenience, it’s a massive expense and time commitment for providers. It’s also dangerous for patients; when a provider doesn’t have an up-to-date, readable medical history, it can delay vital diagnoses and prevent patients from receiving timely, potentially life-saving care.
If there is one problem we can solve in healthcare that will positively impact patients, providers and payers alike, this is it. And thanks to some important regulatory and technological advances — including artificial intelligence — we’re starting to see a large group of leaders and innovators come together to tackle this challenge head on.
Has our investment in electronic health records paid off?
The U.S. government has spent more than $30 billion on incentivizing the use of EHRs since the passage of the HITECH Act of 2009. Unfortunately, focusing only on implementation and not on standardization created a new problem to solve.
Without a standard format or structure for records, we ended up with hundreds of thousands of systems exchanging unstructured data — it wasn’t until 2014 that the first official Fast Healthcare Interoperability Resources standards were published.
In addition to the issues around interoperability, we’ve also lacked a standard process for inputting the physician progress note into the EHR. An enormous amount of clinical value is found in that unstructured note, and without a readable format, that information goes to waste.
Because of these problems — along with slow adoption of new technologies among clinicians — healthcare is still faxing billions of pages of medical records every year.
New regulations and standards can help solve the interoperability problem
Recent advances in regulation and standardization are laying the groundwork for important progress in the coming years. Over the past decade, the implementation of standards like FHIR has created a standardized format for medical record data.
And with the 21st Century Cures Act, we’ll soon see the emergence of a regulated, mandated, and interoperable national network under the Trusted Exchange Framework and Common Agreement.
It will take an enormous amount of effort and collaboration to implement these changes at scale. But with the lessons learned since 2009 in mind, these regulations provide a vital foundation that was missing from previous legislation.
Artificial intelligence and machine learning have a vital role to play
Advancements in artificial intelligence and machine learning offer an unprecedented opportunity to synthesize medical record data into a readable, structured form.
Consider the volume of care a patient receives throughout their entire lifetime. Especially for an individual with one or more chronic conditions, one patient’s entire history is often spread across hundreds of pages of documents, with no means to connect them into a structured narrative.
Today, when we pull data on a patient digitally, we get an average of 43 clinical documents per patient. These can be in any format — HL7, FHIR, CCDA, or even a JPEG or TIFF. And then within each file, there’s an enormous amount of unstructured clinical narrative.
Artificial intelligence can play a key role in synthesizing these records — extracting diagnoses, lab results, medications, procedure history, and more — into a finely-tuned, digital record that’s fully searchable and comparable.
These records will reduce both the cost of treatment and time to treatment, making it easier for clinicians to provide the care patients need, when they need it.
Using existing technologies to build a scalable, user-friendly solution for medical records is not just a useful innovation. It is a vital step we must take if we want to solve the $125 billion problem of medical record retrieval and analysis.
By Dan Leibu, co-founder and chief operating officer, League.
In the wake of the COVID-19 pandemic, the healthcare industry rapidly adopted new technologies and processes to improve care delivery and keep patients and staff safe. The adoption of telemedicine and digital front doors has allowed healthcare providers to continue delivering care to patients while minimizing the risk of spreading COVID-19 and making care more accessible to patients. Yet, the pandemic exposed gaps in our healthcare system, including the need for an underlying platform that connects all aspects of patients’ health journeys.
As we move into the endemic stage of COVID, with President Biden set to end all COVID-19 emergency declarations in May 2023, we have the chance to reflect on the successes and shortcomings of our national pandemic response and apply those lessons to make our healthcare system even more resilient and prepared for future pandemics and crises.
A platform approach to contact tracing
When the pandemic reached full force in Spring 2020, it generated a rush to implement solutions for contact tracing to stem the rapid spread of the virus. By December 2020, at least 74 countries had launched apps to automate and assist contact tracing. In the U.S., companies including Apple and Google rushed to provide aid by rolling out their own contact-tracing technology, but these solutions ultimately proved too disjointed and did not gain the necessary traction to be fully effective.
A platform approach to healthcare would allow for much more efficient and widespread contact tracing during the next pandemic. Healthcare platformization could facilitate the wide-spread implementation of a single, unified contract tracing solution that would provide a streamlined and accessible user experience.
Expanding care access
During spikes of the COVID-19 pandemic, overburdened providers, high patient loads, and limited hospital beds necessitated hospitals to triage care. Likewise, many patients avoided visiting hospitals and doctors’ offices to protect themselves or were turned away. A study by the Center for Disease Control found that by June 30, 2020, an estimated 41% of U.S. adults had delayed or avoided seeking medical care because of COVID-19, including emergency care (12%) and routine care (32%). Avoidance of emergency care was more prevalent among those with underlying medical conditions and disabilities, unpaid caregivers for adults, and Black and Hispanic adults, demonstrating the effect of social determinants of health on care access.
In addition to the obvious risks associated with delaying emergency care, persistent difficulty accessing routine and preventive care can lead to serious medical conditions going undiagnosed or unchecked. Many patients with chronic conditions such as diabetes, heart disease, and autoimmune disorders were forced to manage their health at home.
For most people, going to the doctor for a quick check-up usually just means driving to the hospital. However, some people either don’t have the means to travel or they might require special equipment or arrangements when being transported. But while their need to access medical services can be considered an essential need, these patients don’t typically require ambulance because they’re not experiencing a medical emergency.
This is where non-emergency medical transportation (NEMT) comes in. For an affordable fee, patients can book NEMTs that will transport them to their destination hospitals or healthcare facilities. Unlike most private vehicles and modes of public transport, NEMTs are designed to carry patients that need special equipment or assistance. NEMTs can smoothly transport people in wheelchairs and stretchers which regular taxi cabs and buses are unable to easily accommodate, if at all.
If you’re thinking about using non-emergency transport services or just curious about how they work, here are a few things about NEMTs that you should keep in mind.
NEMT Providers Use Software to Connect with Patients
NEMT providers and brokers typically take advantage of software solutions to ensure that patients connect quickly with an available NEMT service. By using a custom-made platform, transportation providers can easily schedule the deployment of NEMTs for patients in need. Similar to emergency dispatch in EMS, non emergency medical services software allows NEMT providers to dispatch transports to users who are requesting transports.
NEMT software solutions assess the available vehicles based on their capacity to accommodate equipment such as walkers, gurneys, wheelchairs, and mobility scooters. Upon booking, the NEMT software will also provide billing information with a breakdown of accumulated costs.
