clinical Archives - Medical Association of the State of Alabama

Posts Tagged clinical

A New Anti-Kickback Law Targets Clinical Lab Marketing Arrangements

Posted by admin on February 6, 2019

Some very important and potentially game-changing legislation was recently passed. On Oct. 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (or EKRA) – a statute that potentially eliminates legal protections (i.e., “safe harbors”) used by clinical laboratories to market their services. EKRA is part of the “Support for Patients and Communities Act,” comprehensive legislation designed to address the opioid crisis. The Act is clearly aimed at the use/abuse of opioids and the business practices of recovery centers.

EKRA has several potentially game-changing provisions. The first big development is EKRA’s definition of “clinical labs.” The definition of clinical labs used by EKRA is the extremely broad definition contained in 42 USC 263a. Rather than confining the definition of “clinical lab” to toxicology labs, which would satisfy the legislative purpose of the opioid crisis and business practices of recovery centers, the definition covers ALL clinical labs. Consequently, the reach of the definition of “laboratory” is significantly broader than the purpose of the Support for Patients and Communities Act.

Another important provision of EKRA is the statute is an “all-payor” statute. This means it applies to services that are paid by commercial insurers in addition to services paid by Medicare and Medicaid. Unlike the Anti-Kickback Statute (“AKS”) that only applies to federal payors, EKRA applies to commercial payors as well. This is obviously more expansive than the AKS and may require many clinical labs to examine their business practices as they relate to commercial payors if the labs have carved out arrangements specifically to commercial payors.

Finally and most substantively, EKRA prohibits certain business practices that some clinical labs currently use. EKRA defines payment practices that violate the statute to include compensation to employees or contractors that is based on: the number of individuals referred to a particular recovery home, clinical treatment facility or laboratory; the number of tests or procedures performed; or the amount billed to or received from, in part or in whole, the health care benefit program from the individuals referred to a particular recovery home, clinical treatment facility or laboratory.

This change is important because under the AKS, clinical laboratories and other providers are permitted to pay bona fide employees compensation based on revenues generated from their marketing activities. The OIG has even indicated in several Advisory Opinions that providers could pay independently-contracted sales agents percentage-based compensation so long as the arrangement contained adequate safeguards to address so-called “suspect factors.” The prohibition of paying an employee based on some type of formula that takes into account the amount of business generated by the employee should cause laboratories to review their compensation practices because these compensation arrangements used by any clinical laboratory may no longer be protected.

While there is a possibility the definition of clinical lab will be interpreted to apply only to toxicology labs, it is far from certain. Consequently, any/every clinical laboratory needs to be aware of the new legislation and examine its business practices immediately.

Jim Hoover is a partner at Burr & Forman LLP practicing in the Health Care Industry Group. Burr & Forman LLP is an official partner of the Medical Association.

Tags: clinical, commercial, ekra, kickback, lab, marketing, payor, statute

Posted in: Legal Watch

Protecting One of Your Most Valuable Assets – Your Employees

Posted by admin on November 8, 2018

Several studies show that the total cost of losing an employee can range from tens of thousands of dollars to 150 percent of the employee’s annual salary. There are also the “soft costs” of losing an employee, including lost productivity and lower employee morale if the practice incurs high turnover rates. According to a survey by the Medical Group Management Association, 50 percent of respondents reported that clinical support staff positions, such as nurses and clinical assistants, had the most turnover. When these employees leave a medical practice, they may also take with them valuable, confidential information, including patient lists, fee schedules and vendor contracts.

From a legal (and practical) standpoint, it is very difficult to prevent an employee from leaving a medical practice, but you can implement several strategies to limit the adverse impact.

First, for certain “high-level” employees, the practice can require each employee to sign a non-compete agreement. A typical non-compete agreement would prevent the departing employee from working in a competing business for a certain period of time within a designated area. For a non-compete to be enforceable in Alabama it must be reasonable as to geographic scope (e.g., the service area of the medical practice) and as to duration (e.g., up to two years is presumed reasonable). Further, the non-compete must serve to protect the practice’s “protectable interests,” which includes the practice’s confidential information (e.g., pricing and patient lists and vendor information) and specialized training provided by the practice to its employees. A non-compete should only be used for employees that hold a position “uniquely essential” to the management, organization or service of the practice. Accordingly, a properly drafted non-compete for an administrator or other high-level employees should be enforceable, but a non-compete should not be used, for example, with a receptionist. Further, in Alabama non-compete agreements cannot be used with professionals, which have been defined by the courts to include physicians and physical therapists. Other clinicians that exercise independent, clinical judgment may also fall within this “professional exemption.”

Second, each employee (or at least the physicians and other “high-level” employees) of the practice can be asked to sign a non-solicitation agreement restricting the employee from “hiring away” other practice employees upon their departure. Non-solicitation agreements are common in physician employment agreements, but can also be used for other employees. A typical non-solicitation provision would read: “Employee agrees that, during the term of his/her employment with the Medical Practice and for a period of one year following termination of employment, regardless of the cause of such termination, Employee shall not, directly or indirectly, through any individual, person or entity, without the prior written consent of the Medical Practice: (a) solicit, induce or attempt to solicit or induce away, or aid, assist or abet any other party or person in soliciting, inducing or attempting to solicit or induce away any employee of the Medical Practice, or (b) employ, hire or contract for services with any employee of the Medical Practice, or any person who was an employee of the Medical Practice during the six (6) month period immediately prior to termination of the Employee’s employment with the Medical Practice.”

The final option to consider is a confidentiality agreement with employees. This type of agreement prevents a departing employee from retaining or using any of the practice’s confidential information after leaving the practice. Confidential information can be defined broadly to mean any sensitive or proprietary information of the practice, including all business or management studies, patient lists and records, financial information, trade secrets, fee schedules, and employee and operating manuals. A strong confidentiality agreement will become especially important if an employee leaves a medical practice to work for a competitor.

Howard Bogard is an attorney with Burr & Forman LLP and is the Chair of the firm’s Health Care Industry Group. Burr & Forman LLP is an official partner with the Medical Association.

Tags: assistant, burr, clinical, employee, nurse, staff, support, team, turnover

Posted in: Management

NIH’s All of Us Research Program Kicks Off in Birmingham on May 6

Posted by admin on May 3, 2018

On May 6, the National Institutes of Health will open national enrollment for the All of Us Research Program, a momentous effort to advance individualized prevention, treatment and care for people of all backgrounds. People ages 18 and older, regardless of health status, will be able to enroll. The official launch date will be marked by community events in seven cities across the country, including Birmingham, as well as an online event. Volunteers will join more than 25,000 participants already enrolled in All of Us as part of a year-long beta test to prepare for the program’s national launch. The overall aim is to enroll 1 million or more volunteers and oversample communities that have been underrepresented in research to make the program the largest, most diverse resource of its kind.

“All of Us is an ambitious project that has the potential to revolutionize how we study disease and medicine,” Health and Human Services Secretary Alex Azar said. “NIH’s unprecedented effort will lay the scientific foundation for a new era of personalized, highly effective health care. We look forward to working with people of all backgrounds to take this major step forward for our nation’s health.”

Precision medicine is an emerging approach to disease treatment and prevention that considers differences in people’s lifestyles, environments and biological makeup, including genes. With eyeglasses and hearing aids, we have long had customized solutions to individual needs. More recently, treating certain types of cancer is now possible with therapies targeted to patients’ DNA. Still, there are many unanswered questions leaving individuals, their families, their communities and the health care community without good options.

“The All of Us Research Program is an opportunity for individuals from all walks of life to be represented in research and pioneer the next era of medicine,” said NIH Director Francis S. Collins, M.D., Ph.D. “The time is now to transform how we conduct research — with participants as partners — to shed new light on how to stay healthy and manage disease in more personalized ways. This is what we can accomplish through All of Us.”

By partnering with 1 million diverse people who share information about themselves over many years, the All of Us Research Program will enable research to more precisely prevent and treat a variety of health conditions.

“All of us are unique, but today we live mostly in an era of ‘one-size-fits-all’ medicine,” said Eric Dishman, director of the All of Us Research Program. “I’m alive today because of precision medicine, and I think everyone deserves that same opportunity no matter the color of your skin, your economic status, your age or your sex or gender. In other words, it will truly take all of us.”

All of Us seeks to transform the relationship between researchers and participants, bringing them together as partners to inform the program’s directions, goals and responsible return of research information. These efforts include building trust among populations historically underrepresented in research. Participants will be able to access their own health information, summary data about the entire participant community and information about studies and findings that come from All of Us.

“Building a diverse participant community will be vital to the success of All of Us, so we can address the many pressing health conditions that disproportionately affect underrepresented communities,” said Dara Richardson-Heron, M.D., chief engagement officer of the All of Us Research Program. “The All of Us Research Program has the potential to help researchers better understand and begin chipping away at health disparities so that everyone can benefit from better health, better health care and exciting new breakthroughs.”

Participants are asked to share different types of health and lifestyle information, including online surveys and data from electronic health records, which will continue to be collected over the course of the program.

The surveys will cover a range of topics to learn more about participants’ overall health and habits and where they live and work. The EHR data will offer useful information related to medical histories, side effects and treatment effectiveness. At different times over the coming months and years, some participants will be asked to visit a local partner site to provide blood and urine samples and to have basic physical measurements taken, such as height and weight. To ensure that the program gathers information from all types of people, especially those who have been underrepresented in research, not everyone will be asked to give physical measures and samples. In the future, participants may be invited to share data through wearable devices and to join follow-up research studies, including clinical trials.

NIH has funded more than 100 organizations from community groups to health centers, academic medical centers and private companies to carry out the program. These organizations have collaborated to develop the program’s protocol and technology systems, to engage diverse communities, to enroll participants and to securely gather and store participants’ information and biological samples for use in research.

In future phases of the program, children will be able to enroll and the program will add more data types, such as genetic data. In addition, data from the program will be broadly accessible for research purposes. Ultimately, the All of Us Research Program will be a rich and open data resource for traditional academic researchers as well as citizen scientists — and everyone in between.

Community-based launch events

On the program’s May 6 launch date, the All of Us Research Program will host special events in diverse communities around the country, including:

Birmingham, Alabama
Chicago
Detroit
Kansas City, Missouri
Nashville, Tennessee
New York City
Pasco, Washington

People also may take part in social media activities (#JoinAllofUs) or tune in at https://Launch.JoinAllofUs.org to watch speakers across the country talk about precision medicine and the power of volunteering for research.

To learn more about the program and how to join, please visit www.JoinAllofUs.org.

“All of Us” is a registered service mark of the U.S. Department of Health & Human Services (HHS).

About the All of Us Research Program: The mission of the All of Us Research Program is to accelerate health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us. The program will partner with one million or more people across the United States to build the most diverse biomedical data resource of its kind, to help researchers gain better insights into the biological, environmental, and behavioral factors that influence health. For more information, visit www.JoinAllofUs.org and www.allofus.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Tags: clinical, data, diverse, health, lifestyle, medicine, NIH, precise, precision, research, trial

Posted in: Health