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FDA Pushes Enrollment of Underrepresented Populations in Clinical Trials with Recent ‘Race and Ethnicity Diversity Plan' Draft Guidance

05 May 2022 00:00:00 -0800

Management Update Newsletter Volume 11, Issue 5

02 May 2022 00:00:00 -0800

Four Interesting Developments Out of Louisiana

28 Apr 2022 00:00:00 -0800

10 Things to Know About Government Investigations of Dental Providers

26 Apr 2022 00:00:00 -0800

10 Things to Know About Government Investigations of Dental Providers

Both the Federal and State Governments have significant tools to combat fraud, waste, and abuse in the health care setting. Although most investigations involve those who bill government payors, such as Medicaid or Tricare, the government’s ability to bring civil and criminal actions also applies to claims billed to any health care benefit program. The following is general information regarding government investigations that any dental practitioner should keep in mind. Note that this guidance, while more specific to government investigations, also provides a road map for best practices for all dental practices, including those who see predominately private pay patients.

Billing Patterns Are Important. Both the Federal Government and the State can investigate claims paid through Medicaid. The Government’s investigations are generally driven by two factors: (1) data analysis and (2) whistleblower complaints. Both the State and Federal Government employ analysts who study data trends and look for unusually high billing patterns. Where a provider has an unusually high billing of certain procedure codes, the government will generally audit the provider’s patient records. If the government believes from these records that there is a credible likelihood of fraud or abuse, the government will then request a statistically random sample of files from which it can extrapolate the amount of loss to the government. Note that private health insurers also rely on statistical data to audit and investigate billing patterns for possible recoupment. If your practice has a high volume of certain procedures, make sure that you can explain why your practice performs these procedures more than the average practitioner.
Whistleblowers, Such as Former Employees, Are Important Government Referrals for Fraud. Both Federal Government (through the Federal False Claims Act) and the State Government (through MAPIL) allow whistleblowers to file suit on behalf of the government to recover damages for false or fraudulent claims. The whistleblower is entitled to a certain percentage of the government’s recovery, which incentivizes the filing of claims. The government is generally obligated to conduct a good-faith investigation of the whistleblower’s claims and will prosecute the claims when the whistleblower’s allegations turn out to be credible and supported by the evidence. Usually, the whistleblower is a former (disgruntled) employee with direct knowledge of the billing practices or a competitor who believes the other party is employing uncompetitive techniques. Because knowledge that false billing was occurring is key to government recovery, it is very important to address and/or investigate any and all concerns an employee may have regarding the medical necessity of procedures and the billing of any procedures.
Failing to Remit Overpayments Can Be Considered Fraud. Under the Federal False Claims Act and MAPIL, a claim is considered “false or fraudulent” when the provider discovers that he/she billed by mistake and fails to repay the claims to the government. Once an error in overbilling has been discovered, it is important to remit the overpayment. If the overpayment is significant such that repaying it is not financially possible at the time, consulting with counsel can help you determine your best options in how to handle that matter. Note that the penalties under the False Claims Act and MAPIL provided for statutory fines and up to treble damages of the amount billed, so failing to repay an overpayment can result in enormous financial exposure.
Know Who Your Employees Are. If you bill a government health benefit program such as Medicaid, you need to make sure that none of your employees are excluded from participation in federal health care programs, including Medicaid, which is federally funded. If you inadvertently employ an excluded individual, your claims to government programs that were submitted while the excluded employee was employed are subject to recoupment, fines, and penalties. There is a website to check if your employees are excluded; check it annually to ensure compliance with these regulations.
The Government Can Pursue A Criminal Fraud Claim Even If The Provider Does Not Bill A Government Health Benefits Program. Many providers believe that they are immune from government scrutiny if they do not bill government health benefit programs. However, even where there is no government payor, the Federal Government may nonetheless pursue an action for health care fraud if the claims were made to a private healthcare benefit company. Further, the Government can bring actions under other theories, such as wire fraud and mail fraud. These actions are not as common as health care fraud, but they do exist, and the government will prosecute them vigorously if disclosed to them.
Exercise Caution In Your Referral Relationships. Both Federal and State law criminalize the exchange of “anything of value” for a referral for a health care service, especially those for government program beneficiaries. The Federal and State Government can, and will, bring False Claims Act and MAPIL actions for kickbacks violations even where the practitioner was otherwise in compliance.
Keep Complete Records. Often overpayment determinations are based on the lack of proper documentation in the medical records produced to the government. Not only is it necessary to keep complete medical records, it is also important to produce all relevant records for a service when responding to a government request for records or an audit. Many times the record for the date of service does not contain all the information that supports the service provided—there may be a record of a prior date of service or test/X-ray that confirms the medical necessity of the service. Providing complete documentation of the actual provision of the service and the medical necessity therefore at the front end saves time and money on the back end. More importantly, the sooner you can show investigators that your practice is compliant, the more confidence they will have in you going forward, and are more likely to give you the benefit of the doubt on compliance issues.
Demonstrate Knowledge of Compliance Procedures. When faced with a provider who has wrongly billed for certain claims, the government bases many of its enforcement decisions on whether the improper billing was an error or oversight. If the provider has documentation of policies regarding compliance, the government will take this into consideration if it is looking at recouping an overpayment.
Get In Front of the Investigation. It is very important as a provider to interface with the government agents and attorneys during any investigation. A lot of time there can be a valid reason that the provider has a statistically high billing of a certain procedure—especially if the provider specializes in pediatric dentistry or something similar—because the government may not investigate the background of the provider or the type of practice the provider engages in before launching an investigation. Further, whistleblower complaints often are based on scant facts and can be summarily dismissed. The sooner that you can get in front of the investigators regarding their claims, the easier it will be to defend the case.
Seek Compliance Advice Where Necessary. A lawyer’s practice is full of clients who failed to seek advice from a competent source when faced with a billing or overpayment issue. An experienced healthcare lawyer is always the best source of information regarding government compliance. If you seek guidance from a government representative or a representative of a Managed Care Organization regarding a certain practice or procedure, memorialize their advice in an email or letter to that individual.

As with everything else, when it comes to government investigations, an ounce of prevention is worth a pound of cure. Compliance can be time-consuming and sometimes costly, but the cost of none-compliance can be astronomical.

Catherine M. Maraist is a partner in the Baton Rouge office of Breazeale, Sachse & Wilson, L.L.P. She focuses her practice on white collar civil and criminal defense and healthcare. Catherine has extensive experience in matters involving federal criminal law, federal civil law and procedure, civil and criminal health care fraud, appellate advocacy, trial advocacy, and professional responsibility. Catherine is a writer and lecturer in various areas of federal civil and criminal law, including health care fraud and compliance. Catherine has also served as an instructor in criminal and civil trial advocacy and appellate advocacy programs at LSU Law School and at the United States Department of Justice’s National Advocacy Center.

Do You Hear That Sound? It's The Paid Leave Train, And It's Heading Straight for You

19 Apr 2022 00:00:00 -0800

Most of us are very familiar with the Family and Medical Leave Act, which requires unpaid leave, a continuation of benefits, and reinstatement of employees who take off of work for various health and military-leave related reasons.

Fortunately, the FMLA only applies to employers with fifty or more employees, and we currently have no comparable state law that would apply to smaller employers.

That is probably going to change in the near future.

This week, Maryland became the tenth state to recently pass a law requiring private employers to provide paid family and medical leave. Similar bills are currently pending in at least twenty-five other states, including Louisiana.

Louisiana currently has no less than two Bills pending in the House and Senate that would require private employers to provide paid leave for sickness, and family and parental leave, and one that would require governmental employers to provide similar paid leave benefits. The Bills would variously apply to employers with at least five or twenty employees, and one would apply to state employees. (Senate Bill 289, House Bill 1003, and House Bill 945 respectively).

Although employers do not need to take any concrete action in response to any of these Bills at this time, it would be a good idea to keep them on your radar. If any of these become law, they will present significant changes.

CMS Issues New No Surprises Act FAQS on Good Faith Estimates and the Overall Requirements and Exceptions for Healthcare Providers

14 Apr 2022 00:00:00 -0800

On April 6, 2022, the Centers for Medicare & Medicaid Services (CMS) issued two new Frequently Asked Questions (FAQs) guidance documents on the requirements of the No Surprises Act (NSA) that addressed a provider’s obligation to provide a Good Faith Estimate for uninsured and self-pay patients, and certain NSA requirements and exceptions. CMS also announced plans to launch an online portal through which uninsured and self-pay patients may initiate the Independent Dispute Resolution Process.

The New FAQs on the obligation to provide a Good Faith Estimate (GFE) addressed several questions by healthcare providers including whether the following must be included or addressed in a GFE: diagnosis codes, expected charges for future visits, reoccurring items or services, unforeseen items or services, and when a provider is required to provide a GFE to uninsured or self-pay individuals.

CMS also issued a new FAQ for providers regarding several requirements of the NSA, including: exceptions for when the NSA is applicable, certain non-emergency services by out-of-network providers for patient visits at in-network facilities, required patient disclosures, and continuity of care situations when a provider’s network status changes.

These two FAQS are available at:

New FAQ on the Good Faith Estimate requirements:

https://www.cms.gov/CCIIO/Resources/Regulations-and-Guidance/Downloads/Guidance-Good-Faith-Estimates-FAQ-Part-2.pdf

New FAQ on the overall NSA requirements:

https://www.cms.gov/files/document/faq-providers-no-surprises-rules-april-2022.pdf

Can My Boss Really Fire Me for Talking About His Compensation?

12 Apr 2022 00:00:00 -0800

I recently read an article about a manager who posted this notice in an employee break room:

EFFECTIVE IMMEDIATELY, CONVERSING ABOUT WAGES (BOTH ON DUTY AND OFF DUTY) IS STRICTLY FORBIDDEN.

This is considered proprietary information and as such, it is protected legally. If you are overheard speaking (OR LISTENING TO!!) a conversation in which wages are discussed, you will receive disciplinary action up to and including termination.

As a reminder, Kentucky is an at-will state, meaning that your employment can be terminated for any reason without legal percussion. Or NO REASON.

The fact that Kentucky and Louisiana are both at-will states will not help this employer one bit. This type of policy is specifically forbidden by the National Labor Relations Act, which applies to both union and merit shop employers, and it will also be forbidden in Louisiana if a Bill currently pending in the Senate becomes law.

The National Labor Relations Board has this to say about policies limiting employees’ rights to talk about their compensation.

Under the National Labor Relations Act (NLRA or the Act), employees have the right to communicate with other employees at their workplace about their wages. Wages are a vital term and condition of employment, and discussions of wages are often preliminary to organizing or other actions for mutual aid or protection.

If you are an employee covered by the Act, you may discuss wages in face-to-face conversations and written messages. When using electronic communications, like social media, keep in mind that your employer may have policies against using their equipment. However, policies that specifically prohibit the discussion of wages are unlawful.

You may have discussions about wages when not at work, when you are on break, and even during work if employees are permitted to have other non-work conversations.

If it becomes law, Louisiana Senate Bill 410 will also make it unlawful for an employer to act against an employee for “inquiring about, disclosing, comparing, or otherwise discussing the employee's wages or the wages of any other employee, or aiding or encouraging any other employee to exercise the same actions.”

Although policies forbidding employees from discussing their pay were common in the “good old days”, I would urge caution in the enforcement of any policy that limits an employee’s ability to discuss their pay today.

Department of Labor Issued Field Assistance Bulletin Showing Emphasis on Retaliation

11 Apr 2022 00:00:00 -0800

On March 10 the U.S. Department of Labor issued Field Assistance Bulletin No. 2022-02: Protecting Workers from Retaliation (“FAB”).

In the FAB, the DOL identified several actions that can constitute retaliation. This is significant because the FAB shows that the DOL intends to be very broad in its application of the retaliation provisions.

For example, the adverse actions listed in the FAB include the usual termination and formal disciplinary actions, but it also includes other, not-so-obvious things such as denying overtime, reducing hours, exclusion from meetings, assignment to a less desirable shift and requiring employees to “kickback” money that the DOL had previously found were owed to them.

The FAB also expands the scope of who may commit actionable retaliation to include almost anyone acting to further the employer’s interests, whether employed by the employer or not.

The FAB also makes it clear that protections against retaliation do not cease when one’s employment ceases; the statutes protect persons who are no longer employed by the employer.

Lastly, the FAB again emphasizes the Memorandum of Understanding between the DOL and the National Labor Relations Board entered in January of this year. As I have written previously, under the MOU, the DOL and the NLRB will share information, and an employee’s complaint of retaliation to the DOL may also lead to an investigation by the NLRB.

Bottom Line: More so than ever, it is important that employers take a studied look at how they respond to employees who engage in protected activity. What an employer calls a paid leave while it completes an investigation may well be seen as an embarrassing suspension by the complaining employee and the DOL.

Management Update Newsletter Volume 11, Issue 4

01 Apr 2022 00:00:00 -0800

Proposed Bill Would Prohibit the Use of Non-Compete Agreements with Certain Physicians

24 Mar 2022 00:00:00 -0800

Senator Jay Morris has proposed a Bill that will significantly limit the use of employment-related agreements that limit a primary care physician’s ability to practice medicine. Senate Bill 385 would prohibit the use of any employment contract or agreement to restrict the practice of medicine by a licensed primary care physician, except for certain limited situations.

For example, employers could only enforce a non-compete provision against a primary care physician whose was terminated for “just cause.” In addition, such a non-compete provision could only restrict the physician from competing for a maximum of one year from the termination of his or her employment contract or agreement. (The current maximum period is two years.)

The geographic area in which the physician could not compete would be limited to the parish in which his/her office was physically located and one contiguous parish.

Any agreement in violation of the new statute would be null and void.

If you employ primary care physicians, and if you utilize non-compete language in your employment agreements, you need to follow the progress of this Bill.