What Is a Serious Adverse Event (SAE)?

By Hari Nath

Introduction

Drugs and medicines are released to the public after passing through several testing phases which are closely monitored by regulatory and governmental authorities. Over and above this, all expected and noted side effects are examined and highlighted in the medicine's packaging or brochure material. However, if a new reaction to a medicine occurs, which is not mentioned in the packaging material, this reaction is defined as a `side effect'. A side effect can be symptomatic, like a headache or nausea or it can be severe and result in death or require hospitalization. Such reactions to medicines are called 'Serious Adverse Reactions' or SAE's.

Serious adverse event is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, results in congenital anomalies/birth defects, or in the opinion of the investigators represents other significant hazards or potentially serious harm to research subjects or others.

Understanding SAE's:

The FDA describes serious adverse reactions as, 'any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, results in congenital anomalies/birth defects, or in the opinion of the investigators represents other significant hazards or potentially serious harm to research subjects or others.'

The keyword in the above description to be noted is `untoward'. This essentially means that the reaction is totally unexpected involving unmitigated risk. Such reactions should be immediately reported to the FDA. Serious adverse effects can be classified by their end results, which are:

Death: If a person's death is the outcome of an adverse reaction to a medicine.

Life threatening: If the patient develops serious symptoms which may result in death, and the cause of this illness can only be attributed to a medicine and not to any existing ailments.

Hospitalization: If a patient requires immediate hospitalization or a prolonged stay to cure the ailment which is a result of a serious adverse reaction to a medicine.

Permanent Damage: If the person's normal ability to control and conduct life functions is hampered or disrupted and the end result is a permanent, incurable damage to the person's physical function or structure.

Congenital: A medical product consumed during pregnancy results in a serious ailment or affliction in the child.

Steps involved in reporting an SAE

Protocol requires that all serious adverse reactions are reported within 48 hours of their occurrence to the FDA. Grading the reaction: This is the first step in evaluating and reporting a serious adverse reaction, where the concerned healthcare professional grades or categorizes the reaction as serious or not serious.

3 Types of HIPAA Certification

By Greg Garner

If you work in any field related to healthcare you have certainly come across the Health Insurance Portability and Accountability Act (HIPAA) in your job. Depending on your responsibilities and your access to personal health information, a HIPAA certification may be a good idea for your job. If you have any kind of direct access to personal health information, it is likely that your employee even requires certification.

If your employer does not require certification, it does not mean it is not relevant to your position. The HIPAA laws are quite complicated and affect a great deal of areas in health care. Non-compliance with HIPAA regulations can result in costly fines and potentially civil lawsuits from patients. Truly, anyone employed in the healthcare industry could benefit from a certification.

There are three main types of HIPAA certifications you can complete. Each is targeted towards a certain aspect of healthcare professional or information technology professional. You may find it useful to become certified in all three HIPAA certifications or just one, depending on your position. Below are the three types of certifications and their definitions, uses, and applications.

• Certified HIPAA Professional (CHP). CHP certification is a Level 1 HIPAA certification. It covers mostly just the basics of HIPAA and does not require any certain education or prerequisites. This is a great certification for all employees in any organization that has access to personal health information. In CHP certification, employees will gain an overview of HIPAA and why it was implemented. Health care executives, risk supervisors, privacy and security employees, nurses, and physicians can all benefit from a CHP certification.

• Certified HIPAA Administrator (CHA). The CHA certification is most applicable to end-users like nurses and hospital administrators who deal directly with the delivery of health care services. The CHA certification focuses heavily on the privacy aspects of HIPAA legislation. The CHA certification is also very patient centric, covering how HIPAA will affect patients in regards to their personal health information and medical records. With CHA certification, end-users will have a solid grasp on patient privacy and HIPAA compliance on a daily basis.

• Certified HIPAA Security Specialist (CHSS). CHSS is a Level 2 HIPAA certification. To qualify for the CHSS certification, participants must already have completed the CHP certification. The CHSS focusing on electronic medical records and the information technology aspects of HIPAA compliance. Graduates will have a deep understanding of security standards and practices surrounding electronic medical records and how it applies to HIPAA. All healthcare information technology employees should complete CHSS certification.

It can be a very costly decision not to have employees to gain HIPAA certification. Costs of non-compliance from fines and civil lawsuits far outweigh the costs of HIPAA certification programs for employees. The more employees in an organization with HIPAA certification, the lower the risk of security breaches or violations of HIPAA laws. To ensure your professional success and the overall success and safety of your organization and the patients it serves, HIPAA certification is a requirement.

For more information, please visit our HIPAA Certification website.

Reasons Why Healthcare Employees Need HIPAA Certification: 3 Points

By Greg Garner

HIPAA (Health Insurance Portability and Accountability Act) training can be undertaken in two ways; through the local medium or through the web-based medium. Choosing how your employees undertake this training depends on your personal preference. HIPAA training includes various rules and regulations about healthcare that all healthcare employees need to know. This knowledge is not only needed to help them serve the patients better but also to protect themselves. All the professions who deal with personal records of people require their employees to know the rules and regulations laid down by HIPAA. For e.g. lawyers, HR personnel, and healthcare professionals are some professionals who need this training.

Employees become more confident and efficient when dealing with patients when they have been trained. This is becausethey can now take adequate measures to ensure that they do not cause a HIPAA violation because they are ignorant of the HIPAA rules.

HIPAA training is of different types and varies with the employee's role in the healthcare organization. Security and privacy are two topics that are covered at all the levels. The aim of HIPAA training is to help employees become aware of the rules and understand them so they can serve the patients in a better way. Once your employees have been trained, they will be working in compliance with the federal laws and you, your organization and your employees will be protected from heavy fines and other punishments that occur as a result of non-compliance. You can be relieved that your employees understand the rules and will do their best to adhere to them.

The three main reasons why healthcare employees need HIPAA training are mentioned below:

• The Health Insurance Portability and Accountability act is a federal law and therefore it is important that all your employees are aware of it. The law requires you to have this training as healthcare organizations deal directly with health records of patients. It will not only benefit your employees but your patients as well. Patients can rest assured that their sensitive information in the hands of employees who will protect it, as the training will teach your employees to protect and safeguard patient information.

• Medical records are confidential and should not be taken lightly. Every patient wants to be certain that their hospital keeps their information confidential. When your employees are HIPAA certified, patients are comfortable choosing your organization over others because they know you take privacy and security very seriously, as stipulated by HIPAA.

• There is a big difference between 'knowledge' and 'practice'. As an employer you need to make sure that your employees not only know the HIPAA rules but implement them as well. HIPAA training will teach them how to implement the rules through real life scenarios.

As a healthcare employer, you want to do your best to make sure your organization does its best to serve the patients better. Online HIPAA training is convenient and you will be able to get all your employees trained in no time. Once they are certified, your employees will have a whole new perspective about patient privacy and security.

For more information, please visit our HIPAA Certification website.

The Future of Behavioral Health Outcome Measurement and Reimbursement

By Sean B Jones

Does your organization track the effectiveness and quality of Behavioral Health care How do you measure effectiveness and quality of behavioral health? Are your measurements of behavioral health linked or correlated with claims data? Are your providers providing quality services? Are your providers effective? Are your providers receiving continuous feedback from their patients on the outcomes of treatment?

These are critical questions Managed Care and Provider Organizations should be asking in today's changing health care environment. The trends in health care are moving toward the measurement of the effectiveness of health care and linking the outcomes to performance based reimbursement strategies.

The Effectiveness of Treatment

Behavioral health treatment is very effective, especially when combined with medication and psychotherapy. However, the history of measuring the effectiveness of treatment is marked with tremendous variability in outcomes from one patient to the next.

This variability in outcome measures has somewhat lead the behavioral health field to be reimbursed differently from other specialties. Consequently, the reimbursement of behavioral health services has differed in reimbursement method and in the amount or value of reimbursement relative to other like specialties. The field of behavioral health continues to struggle on how to measure the outcomes of treatment.

The Value of Treatment

Behavioral Health providers have de-valued the outcomes and significance of treatment by accepting lower reimbursements and agreeing to static reimbursement strategies.

In the dawn of healthcare reform, payors are recognizing the billions of dollars spent on behavioral health every year. Psychotropic medicines are usually one of the top medication spends for health plans every quarter. The effectiveness of hospitalization, outpatient treatment and, psychological testing are constantly in question by payors.

The Mental Health Parity Act has not served providers at the same level as it is serving patients. In the dawn of data analytical driven healthcare reform, BH providers are subjected to the same analysis as medical providers. Many providers challenge the measurement methodologies being applied to determine the effectiveness of treatment. Regardless, soon pay-for-performance relative to quality and outcome measures will be commonplace within the behavioral health industry.

Whether the BH provider community agrees or not, the payors have more data on treatment than any academic institution. The data analytic capabilities of multi-billion dollar payors will drive how care is delivered and reimbursed.

Providers that embrace outcome measures and pay-for-performance will have significant opportunities. Provider organizations have the ability to reclaim recognition for the significance and value of behavioral health treatment.

Outcome Measurement = Better Outcomes

Meta-analysis indicate that individual doctors and clinicians are the key to the variance of behavioral health outcomes. The past decade of research supports that the routine measurement of outcomes leads to improved outcomes, especially for patients identified to be at the greatest risks!

Doctors and clinicians that measure the outcomes of their patients, improve. Outcome informed doctors and clinicians recognize the importance of clinical skill in providing effective treatment. These providers support the desire to improve outcomes by actively evaluating themselves and applying the feedback to the treatment.

"Providers interested in measuring the outcomes of their patients are better providers."

Reimbursement and Outcomes

In the future, providers will receive reimbursement for collecting data and achieving established outcomes measures.

In network provider fee-for-service will be connected to outcomes measurement. Fee-for-service fee schedules will be adjusted to reflect three types of three or four types of providers.

1. Providers not measuring outcomes will receive a relatively low standard fee schedule.
2. Providers measuring outcomes will be provided a higher fee schedule or bonus over the standard fee schedule.
3. Providers maintaining statistically significant outcome measures will receive an even higher reimbursement.
4. Provider groups or integrated behavioral and medical groups that maintain statistically significant outcome measures may receive an even higher reimbursement.

Out of network providers will receive lower reimbursement than the in-network providers on the standard fee schedule. Out of network usual and customary or maximum allowable fees will be based on a percentage of the already low standard fee schedule.

Next Steps

There are many organizations that can help your organization develop and implement an outcome measurement strategy and a process that will bring value to your patients/members and your organization.

Sean B. Jones, MS, MBA, LPC, SAC, CEAP
Consultant