Basic Compliance – “The Intake Forms”

  • Prepared by: Carlos Arce, Esq.
  • Florida Healthcare Law Firm

In business, it is well established that compliance is the key to continuity. In healthcare business, compliance is actually the foundation for revenue. One of the most overlooked, yet easiest, compliance elements healthcare professionals need to focus on when starting up or acquiring a healthcare business are the patient intake forms.

Patient Intake Forms

Compliant patient intake forms should contain elements including, but not limited to: the commencement to patient medical records, patient privacy policies required by HIPAA/HITECH, patient financial responsibility and assignment of benefits, patients’ bill of rights (which are required to be provided by law), patient medical record authorization forms, informed consent over medical care and the use of telehealth.

Nothing listed above is an item that can be overlooked. Each document plays a key role in compliance, which ensures the generation and protection of revenue. Proper patient intake forms are needed across the gamut of healthcare, from the medspa setting through to hospitals. Improper documentation can result in claims denials from payors or possibly a privacy law violation with the Office of Civil Rights.

One of the most common compliance issues with patient intake forms is missing or incomplete privacy rights disclaimers, effectively creating patient populations who are unaware as to how their protected health information (“PHI”) will be utilized or what their provider can or cannot share. Huge liability. Patient intake form requirements also run parallel with posting requirements in the office, which are also routinely overlooked when the intake form foundation is lacking. Patient bill of rights, privacy notices, good faith estimate compliance, and certain fraudulent billing disclaimer language is required for many types of healthcare providers.

Using copies or documents replicated from other health care businesses is a common pitfalls and easy way to miss crucial elements. Forms that are canned or have been reused often fail to account for and include new legal changes as well as the everchanging vital information and requirements dictated by federal and commercial payors. Providers need to evaluate what their current intake forms need to include, what their current set has, and decided whether editing is appropriate or simply creating a brand new updated set.

With the influx of Spanish speakers in today’s South Florida market, in particular, it is also wise to create and provide these vital forms in a duplicate Spanish version. The last thing a medical provider needs is their informed consent form being invalidated because the patient couldn’t read it.

  • Attorney Carlos H. Arce works with the Florida Healthcare Law Firm in Delray Beach, FL. He has deep experience with health law, business law, and mergers & acquisitions. Carlos has handled multi-million-dollar healthcare transactions and has served as out-of-house counsel to various small to large healthcare entities. He can be reached via email at [email protected] or by calling 561-455-7700.

How to Obtain an EIN from the IRS

Amanda Howard, Esq. 

Starting your healthcare practice is nothing short of exciting and exhilarating. In fact, you may be so excited you forget about certain legal requirements. Obtaining an Employer Identification Number (EIN) is one of the many steps to take when getting your business started. Although we are all used to the government complicating things, obtaining an EIN is fairly easy to do!

  • Visit IRS.gov to apply for an EIN. 
  • Select the type of legal structure you are applying for.
  • Select why you are requesting an EIN.  
  • Designate a responsible party.
  • Enter the entity name, where it’s located, where it was incorporated or organized and the date the entity came into existence. 
  • Select what your business does. 

Get Help

As a boutique law firm dedicated to supporting the healthcare community, our goal is to ensure our clients are protected. If you have questions about getting your business started, contact us at Florida Healthcare Law Firm to set up a consultation today.

Understanding the Difference Between Employees and Independent Contractors

Amanda Howard, Esq. 

When getting ready to hire workers such as doctors, mid-levels or administrative staff, you might be wondering if you should classify them as an employee or independent contractor. The IRS, Fair Labor Standards Act and common law have helped to differentiate between the two and doing so is important as misclassification can injure both the hire and you as the employer. 

Employee

The general rule is anyone who performs services for a business is the business’ employee if the business can control what will be done and how it will be done. Generally, employees receive a regular, fixed salary or hourly wage, are eligible for benefits and are directed when and where to do their job. Employers must withhold taxes from their employees’ paychecks and do not provide delegation rights to employees.

Independent Contractor

The general rule is an individual is an independent contractor if the payer has the right to control or direct only the result of the work and not what will be done and how it will be done. Generally, ICs receive payment per each project, are not eligible for benefits and are not directed when and where to do their job. Taxes are not withheld from payment and ICs generally have the right to delegate to others.

Degree of Control and Independence

To better aid in determining whether your hire is an employee or independent contract, weigh the below three factors:

  • Behavioral: Does the business control or have the right to control what the worker does and how the worker does his or her job?
  • Financial: Are the business aspects of the worker’s job controlled by the employer, such as how the worker is paid, whether expenses are reimbursed and who provides tools/supplies.
  • Type of Relationship: Are there written contracts or employee type benefits? Will the relationship continue and is the work performed a key aspect of the business?

Get Help

As a boutique law firm dedicated to supporting the healthcare community, our goal is to ensure our clients are protected. If you have questions about getting your business started, contact us at Florida Healthcare Law Firm to set up a consultation today.

COVID-19 Telemedicine Prescribing Rule Extended By DEA: The Implications Surrounding Your Telemedicine Practice

In its latest Temporary Rule, the Drug Enforcement Administration (“DEA”) extended its rule in response to the COVID-19 Public Health Emergency (“COVID-PHE”) permitting authorized providers to prescribe controlled substances without an in-person medical evaluation in specific circumstances (referred to as, “telemedicine flexibilities”). The DEA extended the telemedicine flexibilities for six months from May 12, 2023, through November 11, 2023, subject to certain conditions. If a patient and a practitioner have established a telemedicine relationship on or before November 11, 2023, however, the same telemedicine flexibilities that governed the relationship to that point are permitted until November 11, 2024.

i. How This May Impact Your Practice, Florida Considerations, and Future Predictions

While the DEA seeks to avoid lapses in care to patients who have relied on the telemedicine flexibilities through the Temporary Rule, the DEA noted—several times—that this extension merely extends the telemedicine flexibilities for a limited period of time. Providers who prescribe controlled medications, including testosterone for hormone replacement therapies and functional medicine practices, should stay alerted and informed of the upcoming changes to their prescriptive authority via telemedicine platforms. The DEA stated that it strongly supports policies that promote access to effective and safe treatment for opioid use disorder through telemedicine platforms and ensuring continued access to necessary controlled medications past the COVID-Public Health Emergency; the same may not be true for treatments utilizing controlled medications such as hormone therapies via telehealth. One of the purposes of the extension is to allow these providers to transition from a reliance of the availability for controlled medication prescriptions, and to give providers enough time to comply with the new standards in the DEA’s final rules. Prescribing practitioners and telemedicine companies and providers should use the extension as an opportunity to transition and comply with the upcoming final rule. Providers should also be prepared to change prescribing practices to patients via telemedicine, especially for Schedule II controlled medications, where it may be impracticable to conduct an in-person evaluation. The DEA stated that it remains vigilant on prescribing practices that it deems problematic through telemedicine capabilities, and the agency noted that it is actively investigating certain telemedicine companies it believes may have engaged in problematic prescribing practices.

Looking forward, the DEA plans to issue one or more final rules that extend, and eliminate, certain telemedicine flexibilities on a permanent basis. The final rule may likely permit practitioners to prescribe controlled substances through telehealth without an in-person evaluation to treat opioid use disorder based on the DEA’s attitudes towards telemedicine flexibilities. Prescribing providers who rely on telemedicine to prescribe controlled substances, especially those not to treat opioid use disorder, should be aware of the development of the final rule(s). With the growth of telemedicine, the DEA may also likely implement at least some telemedicine flexibilities permanently, as well. It is important to remain up to date and prepared.

The Temporary Rule applies to all areas in the United States. Florida, however, has its own restrictions on prescribing controlled substances via telehealth. Although Florida generally permits the prescribing of controlled substances via telehealth, Fla. Stat. § 456.47(2)(c) limits the ability of a telehealth provider to prescribe Schedule II controlled substances to four narrow instances. Taken with the Temporary Rule extending telemedicine flexibilities without an in-person evaluation, including for Schedule II controlled substances, Florida telehealth providers still cannot prescribe Schedule II controlled substances via telehealth to Florida patients unless it is for treatment that qualify for the limited exceptions of Section 456.47(2). Providers should also be aware of rules issued by relevant state Boards surrounding the prescribing of controlled medications. Telehealth providers in Florida must therefore be aware of both Florida and federal rules and regulations to ensure that they have compliant prescribing practices.

The DEA’s changes have and will affect businesses and practices that rely on telemedicine for treatment and may require substantive changes to telemedicine prescribing practices to be compliant with the changing rules. This temporary rule is only one of many expected rules that are evolving the landscape of telemedicine in the post-COVID world.

What is the Statute of Limitations, and How Does it Affect Healthcare Providers?

Overview of the Statue of Limitations

The statute of limitations is a legal rule that sets a specific time period within which a lawsuit or legal claim must be filed. It establishes a deadline for initiating legal action based on the type of case or the nature of the claim. Once the statute of limitations has expired, the right to bring a lawsuit or claim is generally lost, and the defendant can use the defense of the expired statute of limitations to have the case dismissed.

The purpose of the statute of limitations is to ensure that legal disputes are resolved in a timely manner. It provides a sense of finality and allows potential defendants to have certainty and protection against stale or outdated claims. The specific length of the statute of limitations varies depending on the jurisdiction and the type of case involved. Different types of claims, such as personal injury, contract disputes, or property damage, may have different time limits for filing.

It’s important to note that the statute of limitations can vary between different states or countries, and even within different jurisdictions within the same state.

Statue of Limitations for Malpractice Claims in Florida

In Florida, the statute of limitations for medical malpractice claims is generally governed by Section 95.11(4)(b) of the Florida Statutes. The statute of limitations for medical malpractice in Florida is as follows:

Standard Statute of Limitations: The general rule is that a medical malpractice lawsuit must be filed within two years from the date the incident occurred or within two years from the date the incident was discovered or should have been discovered with the exercise of reasonable diligence.

Statute of Repose: However, there is a statute of repose that imposes an absolute deadline for filing a medical malpractice claim, regardless of when the incident was discovered. In Florida, the statute of repose for medical malpractice is four years from the date of the incident. This means that even if a patient discovers the malpractice after the four-year mark, they generally cannot bring a lawsuit (see below for exceptions).

In general, if the statute of limitations has expired, it can be challenging to pursue legal action. However, there are a few limited circumstances where a plaintiff may be able to extend these limitations:

Tolling of the statute: The statute of limitations may be temporarily suspended or “tolled” under certain circumstances. For example, if the plaintiff is a minor, the statute of

limitations may be tolled until they reach the age of 18. Other situations that may toll the statute include mental incompetence or the defendant’s absence from the state.

 

Fraud, concealment, or misrepresentation: If the defendant engaged in fraud, intentional concealment, or fraudulent misrepresentation that prevented the plaintiff from discovering the harm or injury, the statute of limitations may be extended.

Continuous treatment: In medical malpractice cases, if there was a continuous course of treatment by the same healthcare provider for the condition that gave rise to the claim, the statute of limitations may be extended to two years from the date of the last treatment.

In conclusion, the two and four year limits apply to most circumstances, but there are situations where a plaintiff is successful in extending the time limitations. So, whether you are joining, leaving, selling or buying a practice, you should choose your malpractice and tail coverage carefully to make sure you are protected.

The Hidden Healthcare Compliance Risks in Cash Pay 

Prepared by: Carlos Arce, Esq. 

Florida Healthcare Law Firm 

Increasing concerns about underpayment and non-payment by insurance companies have providers focused more than ever on cash services. Many of the active and emerging players in the med spa, iv hydration therapy, and concierge medicine spaces are misguided on the issue of compliance, however. Both legal exposure and healthcare regulatory compliance create real risk, even in the cash pay space. 

 

Medical Malpractice & Negligence  

It is well established law that a cash healthcare business which does not seek reimbursement from insurance carriers does not require a Health Care Clinic License granted by AHCA if owned by non-providers. However, not being governed by Florida’s healthcare police doesn’t mean you don’t need to govern and operate as a medical practice, quite the opposite. You are required to keep medical records in accordance with health care privacy laws and you are required to ensure that your medical providers render medical care within the standard of care. 

For the most part all providers under Florida law with the exception of MD’s and DO’s are required to have active insurance policies. Which means, hiring an MD or DO to render services for your med spa will raise the question whether they carry professional liability insurance or are considered “bare” under Florida law. If you hire a mid-level such as an advanced practice registered nurse, do they have professional liability coverage that extends over med spa type services or is the insurance only for primary care. Last, as the practice who intakes the patients and serves as the records custodian, does the practice (med spa) carry professional liability insurance. Are you prepared if your provider commits malpractice?  

 

Employee or Independent Contractor 

Compliance with labor and health care laws is as important if not more important than the insurance issue mentioned above. Many med spa’s engage medical providers to perform services on a menu basis or at a fixed rate but do not have an agreement in place specifying whether the provider is an employee or independent contractor. Having an agreement in place is not only a labor concern but could potentially subject you to risk under Florida’s Healthcare Laws (specifically, Florida’s Patient Brokering Act). You see Florida has adopted the federal health care laws, the Anti-Kickback Act and the Physician Self-Referral Law through Florida Statute 817.505 “Patient Brokering Act” and Florida Statute 456.053 “Patient Self-Referral Act of 1992”. Patient Brokering Safe Harbors must be complied with when medical practice’s engage medical providers to perform service on behalf of their practice. If you don’t comply with requirements under the “Personal Services” or “Bona Fide Employee” Safe Harbor you could be held guilty of paying kickbacks.  

The above are only a few of the regulatory and legal concerns surrounding cash pay, Med Spa’s. We suspect that when business increases legal and compliance requirements follow. Coming to the table early will be difference between addressing legal issues on a reactive front versus a proactive approach.  

 

Attorney Carlos H. Arce works with the Florida Healthcare Law Firm in Delray Beach, FL. He has deep experience with health law, business law, and mergers & acquisitions. Carlos has handled multi-million-dollar healthcare transactions and has served as out-of-house counsel to various small to large healthcare entities. He can be reached via email at [email protected] or by calling 561-455-7700. 

Mobile IV Clinic Little Known Concerns

Mobile IV clinics are booming through the United States and most medical providers understand that generally a physician must be involved in the process, the person administering the IV product needs to be a medical professional, the State may have some licensing requirements, and there ought to be appropriate levels of documentation. 

 

However, there are tangential concerns that need to be considered to minimize liability and regulatory overview: 

 

  1. Pharmacy and Drug Regulations: Mobile IV clinics may be subject to pharmacy and drug regulations if they administer medications or IV solutions. These regulations may include obtaining a pharmacy license, adhering to storage and handling requirements for medications, and implementing controls to prevent diversion or misuse of controlled substances.

 

  1. Medical Transportation: Mobile IV clinics may have to comply with regulations related to medical transportation, including those related to driver qualifications, vehicle maintenance, and emergency preparedness.

 

  1. Business Licensing: Mobile IV clinics may have to obtain an appropriate business licenses and permits to operate. These requirements may vary by location, but may include a general business license, a certificate of occupancy, and zoning permits.

 

  1. Infection Control and Safety: Mobile IV clinics must adhere to strict infection control and safety protocols to prevent the spread of disease and minimize the risk of infection. This may include requirements for proper hand hygiene, sterilization of equipment, and monitoring for signs of infection.

 

  1. Workers Compensation: If you own and run a small business with a small number of employees (or even just one employee – the owner) you need to check your State’s Workers Compensation requirements.  Many States allow individuals and/or companies to opt out of the Workers Compensation program, but you may have to submit the required documentation with the State.  Otherwise, you may end up getting a deficiency notice from the State WC Board. 

NSAIDS & The IV Business

Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used medications that can help to relieve pain, reduce inflammation, and lower fevers. Toradol is a prescription NSAID that can be administered via intravenous (IV) injection. Even though Toradol and other NSAIDs are commonly used and are relatively safe medications, these drugs can also have side effects, especially when used in high doses or for prolonged periods of time. To ensure safe and appropriate use of Toradol and NSAIDs, healthcare providers who offer these drugs may be subject to reporting requirements.

 

  1. Adverse Event Reporting: Healthcare providers who offer NSAIDs may be required to report adverse events associated with these drugs to regulatory agencies, such as the U.S. Food and Drug Administration (FDA). Adverse events may include side effects such as gastrointestinal bleeding, kidney damage, or liver damage. Reporting requirements may vary by jurisdiction, but healthcare providers should be aware of their legal obligations to report adverse events promptly and accurately.

 

  1. Prescription Monitoring: In some jurisdictions, healthcare providers who offer NSAIDs may be required to participate in prescription drug monitoring programs. These programs aim to prevent prescription drug abuse and diversion by monitoring the prescribing and dispensing of controlled substances. Providers who prescribe or dispense NSAIDs may be required to report certain information, such as patient demographics, drug dosage and frequency, and the number of doses prescribed.

 

  1. Record-Keeping: Healthcare providers who offer NSAIDs should maintain accurate and complete records of patient care and treatment, including information about NSAID use. This may include the patient’s medical history, dosages and frequency of NSAID use, and any adverse events or side effects. Healthcare providers should be aware of applicable laws and regulations governing the retention and confidentiality of medical records.

 

  1. Compliance with State and Federal Laws: Healthcare providers who offer NSAIDs should be familiar with and comply with all applicable state and federal laws and regulations governing the use of prescription drugs. This may include requirements related to prescription writing, dispensing, and record-keeping, as well as reporting requirements for adverse events or other drug-related incidents.

Fraud & Abuse in the Dental Space

Prepared by: Carlos Arce, Esq.

Florida Healthcare Law Firm

Recently the Department of Justice released a statement relating to a Dentist and Dental Hygienist being charged for fraud.[1] The dental practice is being accused of fraud and false claims against Medicaid. The fraudulent allegations include false claims related to dental services bill toward D.C. Medicaid for two CPT codes (clinical crown lengthening and space maintainers) totaling more than $4,000,000 in Medicaid funds. The charges also include conspiracy and wire fraud, that carry 20-year maximum prison time, and the false claims carry a 10-year maximum prison time. The decision on sentencing will be determined by the court under advisory sentencing guidelines and other factors.

Typically, dentists don’t focus heavily on traditional healthcare law compliance, but they should. Most dentists inherently take Medicare, Medicaid, Tricare, and many forms of commercial insurance. Most patients who have insurance which reimburses for dental care is in the form of federal insurance, not commonly through in commercial insurance. Over the last few years many Medicare Advantage plans have incorporated dental care in their benefits, which will only heighten compliance for dentists in the years to come.

What does this mean for a dentist? For starts the typical fraud & abuse healthcare laws apply and are relevant as they relate to their operations and billing practices. The Anti-Kickback Statute 42 U.S.C. § 1320a-7b(b), False Claims Act 31 U.S.C. § § 3729-3733, Physician Self-Referral Law 42 U.S.C. § 1395nn, Civil Monetary Penalties Law 42 U.S.C. § 1320a-7a, and the equivalent laws at the state level are just a few of the Fraud & Abuse laws which would apply to a dental practice or dental group who takes insurance.

Not only does non-compliance with the health care laws raise legal concerns, but it lowers the overall value of a dental enterprise with multiple locations. Acquisition teams backed by private equity and venture capital are only looking to invest in enterprises which are compliant and operating legally, the risk is not tolerable when Acquisition teams are using investment money for acquisitions.

A few of the items to consider; does your dental enterprise have a compliance plan, does your dental enterprise bill federal and state insurances, does your dental enterprise transfer patients between locations for designated health services, and are you billing under multiple EIN’s.

____________________________________________________________________________

Attorney Carlos Arce works with the Florida Healthcare Law Firm in Delray Beach, FL. He has deep experience with bodily injury trial work and in health law. Carlos has handled multi-million-dollar healthcare transactions and serves as out-of-house counsel to various small to large types of healthcare entities. He can be reached via email at [email protected] or by calling 561-455-7700.

[1] Local Dentist and Hygienist Charged With Offenses Related to Healthcare Fraud and False Claims to D.C. Medicaid, April 20, 2023. https://www.justice.gov/usao-dc/pr/local-dentist-and-hygienist-charged-offenses-related-healthcare-fraud-and-false-claims-dc

Increasing Fraud & Abuse Enforcement in the Dental Space

Prepared by: Carlos Arce, Esq.

Florida Healthcare Law Firm

Recently, the Department of Justice released a statement relating to a Dentist and Dental Hygienist being charged for fraud.[1] The dental practice is being accused of fraud and false claims against Medicaid. The fraudulent allegations include false claims related to dental services bill toward D.C. Medicaid for two CPT codes (clinical crown lengthening and space maintainers) totaling more than $4,000,000 in Medicaid funds. The charges also include conspiracy and wire fraud, that carry 20-year maximum prison time, and the false claims carry a 10-year maximum prison time. The decision on sentencing will be determined by the court under advisory sentencing guidelines and other factors.

Any dentist who has patients with federal insurance that reimburses for dental care, i.e., Medicare, Medicaid, and Tricare must invest in understanding the laws, options and risks associated with this business decision. Over the last few years many Medicare Advantage plans have even incorporated dental care in their benefits, which will only heighten the need for attention to regulatory compliance for dentists in the years to come.

A few of the fraud & abuse laws which apply to a dental practice or dental group which takes federal insurance include the laws that relate to operations and billing practices, such as: The Anti-Kickback Statute 42 U.S.C. § 1320a-7b(b), False Claims Act 31 U.S.C. § § 3729-3733, Physician Self-Referral Law 42 U.S.C. § 1395nn, Civil Monetary Penalties Law 42 U.S.C. § 1320a-7a, and the equivalent laws at each state level.

Not only does non-compliance with the health care laws raise legal concerns, but it lowers the overall value of a dental enterprise with multiple locations. Acquisition teams backed by private equity and venture capital are only looking to invest in enterprises which are compliant and operating legally. Simply put,  taking the risk of investing in anything that isn’t completely buttoned up is not worth it.

A few more questions to consider: Does your dental enterprise have a compliance plan? Does your dental enterprise bill federal and state insurances? Does your dental enterprise transfer patients between locations for designated health services? Are you billing under multiple EIN’s? Not knowing the answer to any of these is no excuse for noncompliance, and may have far reaching and expensive penalties.

____________________________________________________________________________

Attorney Carlos Arce works with the Florida Healthcare Law Firm in Delray Beach, FL. He has deep experience with bodily injury trial work and in health law. Carlos has handled multi-million-dollar healthcare transactions and serves as out-of-house counsel to various small to large types of healthcare entities. He can be reached via email at [email protected] or by calling 561-455-7700.

[1] Local Dentist and Hygienist Charged With Offenses Related to Healthcare Fraud and False Claims to D.C. Medicaid, April 20, 2023. https://www.justice.gov/usao-dc/pr/local-dentist-and-hygienist-charged-offenses-related-healthcare-fraud-and-false-claims-dc