EKRA Compliance

ekra law

The Eliminating Kickbacks in Recovery Act of 2018, or EKRA Law, was enacted by Congress as a part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as the Support Act.

The EKRA law makes up Section 1822 of the Support Act. It was designed to put a stop to the practice of accepting kickbacks for referring patients for treatment to inpatient rehab, outpatient treatment, and/or sober houses or recovery homes.

While EKRA targeted the addiction recovery industry, it is applicable across healthcare industries regardless of specialty. It further bolstered already existing laws prohibiting healthcare professionals from getting kickbacks for referring patients to government-funded or private healthcare options.

The price for violating this law and getting caught is steep. Currently, the penalty may include up to $200,000 in fines, up to 10 years in prison, or a combination of both.

EKRA Law: What Is It?

EKRA regulations provide for the protection of patients. It is no longer legally possible for a medical doctor to prescribe OxyContin to a patient and then make money for referring that patient to treatment when they developed an addiction within a year of regular use.

In Florida, this was an especially important law. By 2017, the opioid epidemic had reached such a crisis that then-Governor Scott declared a statewide public health emergency as a result. He addressed the fact that Floridians were suffering and that, in many cases, people with addictions were coming from out of state to take advantage of easy access to opioid painkillers through what were often called “pill mills.”

It was rarely this straightforward of a process and may not have always had malicious intent behind it when it did occur. Still, EKRA put a halt to the practice of giving remuneration of any kind in exchange for a referral for a new patient, not just in the addiction treatment world, but also among dentists, clinical labs, primary care physicians, and medical specialists of all kinds.

Is the EKRA Lab Law Different From the EKRA Law?

No, but the term EKRA lab law often specifically points to the impact of the EKRA law on clinical laboratories. The law defines “laboratory” as any facility that provides “biological, microbiological, serological, chemical, immuno-hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body.”

This means, for example, that if any lab that is providing copious blood tests, urine tests, or tests of any kind to a healthcare facility in which it may be deemed as fraudulent for the purposes of billing insurance, or any facility engaged in this behavior, they can be charged under the EKRA Lab Law.

How to Maintain EKRA Compliance

Maintaining EKRA compliance is relatively straightforward. Florida Healthcare Law Firm can help to ensure that your organization, clinic, or lab is staying well within bounds. Contact us today for a consultation.

Reducing Risks in CCCs with Personal Caregiver Handbooks

Developing a Personal Caregiver Handbook that spells out expectations and accountabilities of both the resident hiring the caregiver as well as the caregiver is one of the best defenses to issues of liability that may arise.  But where do you start in building out the Handbook?  Here are some key considerations as well as areas that should be covered in the Handbook:

Prior to Developing Handbook

Because the CCC’s relationship with its residents is governed by each resident’s agreement and any move-in documents that accompanied that agreement, it is important first to review those documents to determine if there are any barriers to implementation.  Because each resident contract might be different, this process might require review of all versions in effect for any current residents.

Assuming the resident contracts do not require any additional steps before rolling out such a program, the CCC can move to the drafting of the Personal Caregiver Handbook.Continue reading

Real Risks of Caregivers on Continuing Care Community Property

Providing a high-quality and safe environment and care for vulnerable seniors is a top priority for continuing care communities (CCCs).  Senior communities that provide a full continuum for seniors aging in place (including independent living, assisted living, skilled nursing, and memory care) often focus their safety concerns and resources on the licensed areas of the community, where falls and skin breakdown are the subject of lawsuits.  Sometimes overlooked are the risks that arise when independent living residents bring their own personal caregivers into the community to support their needs.

Growing Use of Personal Caregivers

More and more seniors are finding safety and security in CCCs throughout the country.  And, as they age in place, maintaining that independence often involves the use of personal caregivers who come into the CCCs and create additional risks.  Each time a personal caregiver is allowed admittance to the CCC, real risk is created- and that risk can lead to legal liability, including:

  • Injury to other residents
  • Injury to the resident that hired the caregiver
  • Injury to the caregiver caused by other residents
  • Slip, trip and fall (or other general liability claims) by the caregiver against the CCC
  • Theft/damage to property

But there are a few basic steps that a CCC can do to reduce those risks, while still allowing residents their independence.  Here are some simple considerations:Continue reading

Healthcare Fraud Scheme Indictment Starts the New Year

The U.S. Attorney arrested 13 people in a $100 Million healthcare fraud scheme in NY and NJ involving automobile insurance claims.  Some of the facts alleged include—

  • Bribed 911 operators and hospital employees for confidential information of insured drivers
  • Unnecessary and painful medical procedures
  • A non-physician owning medical clinics
  • Paying hundreds of thousand of dollars to “runners” who used the money to bribe people

Healthcare businesses that largely serve people injured in motor vehicle accidents remain a top tier focus for law enforcement and special investigative units (SIUs) of insurers.  But so do many other providers in the healthcare sector, such as pharmacies, durable medical equipment (DME) providers, addiction treatment providers and labs.  Payer and governmental presumption is often that financial motives are driving clinical behavior, NOT documented medical necessity.  Hence the need for active compliance plans and policies and procedures that don’t sit on a shelf, but rather are woven into daily business and clinical operations.  Nothing less than the right contracts, the right compliance plan and the right business culture will establish and maintain a sustainable healthcare business!

OIG Revises Self-Disclosure Protocol

On November 8, 2021, The Department of Health & Human Services (HHS), Office of Inspector General (OIG) released a revised and renamed Provider Self-Disclosure Protocol (SDP), now known as the “Health Care Fraud Self Disclosure “protocol. The SDP was created in 1998, and the protocol can be used to voluntarily identify, disclose and resolve instances of potential fraud involving federal healthcare programs. As described on the OIG website, “Self-disclosures give persons the opportunity to avoid the costs and disruptions associated with a Government-directed investigation and civil or administrative litigation.”Continue reading

Mitigating the Risk of Personal Aides in Continuing Care Communities

continuing care community law personal aid liability risk managementMore and more seniors are finding safety and security in continuing care communities (CCCs) throughout the country.  And, while they want the increased safety and security, they do not want to lose their independence.  Aging in place and maintaining that independence often involves the use of various personal service providers (PSPs) who come onto the CCC campus and create new risks.  PSPs go by many names and perform many functions, including housekeeping, meal preparation, assistance with activities of daily living (bathing, grooming, eating), grocery shopping, dog walking, and driving the resident to various offsite appointments.Continue reading

Surprise! “No Surprises Act” Enforcement Delayed

It should come as no surprise that the federal government has decided to delay enforcement of the No Surprises Act.  So although the Act will still take effect on January 1, 2022, the government will not enforce certain provisions of the law until applicable rules are in place.  This will hopefully allow the providers, and the government, time to figure out the best way to comply with the law.

The most difficult provision of the No Surprises Act will likely be the “good faith estimate” requirement.  Under the law, when an individual provider or facility schedules a patient for services, they will be required to gather information about the patient’s payor status.  If the patient has insurance, the provider/facility must send a good faith estimate of the expected charges, billing and diagnostic codes to the insurer.  If the patient is uninsured, that information must be given to the patient.Continue reading

What Is a Laboratory Compliance Specialist?

Laboratory Compliance Specialist

There are very strict rules and regulations in place for any business working in a lab, both to protect the healthcare professionals working in that lab and the clients and customers the lab serves.

To make sure that your company is in compliance with these laws, it is recommended to hire a laboratory compliance specialist to double check the details and make sure that all processes are up to code.

What Is Laboratory Compliance?

Laboratory compliance is an ongoing effort put forth by healthcare businesses to ensure that they are up-to-date on all licensing and regulatory requirements.

State, local, and federal agencies may require compliance with a long list of ever-changing rules and directives. It is the responsibility of the business to maintain awareness of those regulations and to ensure that they are operating according to standards and providing proof of that when necessary.

Laboratory Compliance Specialist Definition

When it comes to maintaining laboratory compliance, a laboratory compliance specialist is essential. Sometimes called compliance officers, these professionals are responsible for keeping up with the latest changes and requirements and making sure that the company is doing everything they need to do.

This doesn’t just mean coming in once a year to check that everything is in compliance or responding when there is a violation. It means creating a compliance program that includes policies, processes, and procedures that ensure continual compliance.

Additionally, if there is an audit, investigation, or suspicion of a violation, the laboratory compliance specialist will dive into the problem, handle whatever results from the audit, and adjust policies and procedures accordingly.

Does Your Healthcare Business Need a Laboratory Compliance Plan?

Learn more about how laboratory compliance can impact your healthcare business legally and create a laboratory compliance plan that will protect you in court when you call Florida Healthcare Law Firm now.

A Self-Audit Checklist for Laboratories

By: Dean Viskovich

The Office of Inspector General (OIG) and other Federal agencies charged with responsibility for enforcement of Federal law have emphasized the importance of voluntarily developed and implemented compliance plans.  The government, especially the OIG, has a zero- tolerance policy towards fraud and abuse and uses its extensive statutory authority to reduce fraud in Medicare and other federally funded health care programs.  The OIG believes that through a partnership with the private sector, significant reductions in fraud and abuse can be accomplished.  Compliance plans offer a vehicle to achieve that goal.  The OIG has provided a model compliance plan for clinical laboratories to assist laboratory providers in crafting and refining their own compliance plans.

The OIG suggests that the comprehensive compliance program should include the following elements:

Continue reading

When Was Your Last Regulatory Compliance Audit?

health care professionals attorney

health care professionals attorneyRegulatory compliance audits can help you head off lawsuits before they get started. Learn how to set a schedule based on your organization’s unique risks and benefits, and let trained legal counsel help you. 

As a healthcare executive, it’s your job to craft policies that protect your patients, your staff, and your community. Regulatory compliance audits help you do your work effectively. But if you dread them, you’re not alone. 

It’s not uncommon for organizations to postpone and delay compliance work. No one likes the hassle. But a healthcare practice attorney could help you both set up an audit schedule and complete your tasks with ease. 

When Is a Regulatory Compliance Audit Required?

Every healthcare organization faces a unique set of compliance risks. It’s critical for you to understand your environment intimately and design your audit schedule accordingly. 

Typically, regulatory compliance audits are performed:

  • On a schedule. If your organization is large and includes plenty of service lines, you’ll need to assess risks more frequently than a smaller, targeted organization. 
  • After an issue is detected. Some healthcare legislation requires proof that you’ve learned from your mistakes. If a compliance problem appears, an audit can help you determine how it happened and what you can do to prevent the next issue. 
  • After hefty staff turnover. Everyone on your team must understand how the rules work and why they are important. That’s not always easy for health professionals. Attorney support can be critical. 

Your schedule may change as your organization grows or shrinks. And you may need more audits one year than another. Flexibility is critical. 

Why Do Healthcare Practice Attorneys Perform Audits? 

If you’re a do-it-yourself executive, the thought of hiring someone to help you achieve compliance may seem unusual or strange. But the benefits are both real and plentiful.

A healthcare practice attorney can offer you:

  • Confidentiality. The information gleaned during the process remains between the two of you, and it’s protected from disclosure. 
  • Expertise. The rules and regulations you must follow can be hard to both read and understand. Healthcare practice attorneys specialize in these sorts of documents, and they can explain them to you quickly and carefully. 
  • Impartiality. It’s easy to make excuses for your employees (and yourself). Professionals can look over your records dispassionately, so you can make smart decisions. 

At Florida Healthcare Law Firm, we specialize in regulatory compliance audits. Our healthcare practice attorneys can walk you through the laws and help you stay on the right side of the law. Contact us to find out more about how these audits work and how you can get started.