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Can I Continue to Run a Medical Practice After the Sole Physician’s Death?

Authored by Marcus Leonard and Jamaal R. Jones, Esq.

Authored by Marcus Leonard and Jamaal R. Jones, Esq.

Inevitably, we will all pass away at some point in hopefully the distant future. Some of our deaths will be expected while others will come as a complete shock. Many people formulate a plan for after their passing and make arrangements accordingly for the succession of their personal and business affairs and belongings, while others do not. Occasionally, that deceased person happens to be the only physician in the medical practice. The staff and surviving family members have to quickly determine what their options are and whether they can legally continue to operate the practice without the physician.

Florida does not have the same Corporate Practice of Medicine Prohibitions as other states. In short, this means that you do not have to be a licensed medical doctor or doctor of osteopathy to own a medical practice. Many people erroneously believe that because of this fact they can continue to run the physician’s practice without taking any further action after she passes away. The Florida Health Care Clinic Act (the “Act”) requires that all health care clinics operating in Florida maintain a valid license by the State unless they fall within a statutory exemption. Also, if the health care clinic is cash-pay only and not accepting reimbursement from a commercial payor, Medicare or Medicaid then Florida law allows the business to continue to run without first obtaining the license. According to the Act, a “clinic” is defined as an entity which provides health care services to patients and bills third party payers for reimbursement for providing those health care services. Clinics that are “wholly owned by one or more licensed health care practitioners” are exempt from obtaining a health care clinic license. Thus, if a clinic is owned by a licensed health care practitioner who is supervising the services performed at the clinic and who is legally responsible for the entity’s compliance with all federal and state laws, the clinic falls within one of the exceptions and is exempt from the Act’s licensure requirements. However, in the untimely event that a sole physician/owner passes away, the clinic is no longer afforded exemption from the Act’s licensing requirements and is no longer in compliance with the law.

 

What are my Options?

In this instance, the family members have the following choices: (1) close the practice; (2) sell the practice; or (3) apply for a health care clinic license. If the decision is made to close the practice then you have to make sure that you wind up and dissolve the business accordingly. Alternatively, it can be tricky if the decision is made to sell the practice. Even if you hire another physician to provide treatment to the patients while you try to find a buyer for the practice you will still be violating the Act. As a result, you must not continue to provide health care services until the practice is sold to someone or an entity that qualifies for an exemption under the Act or until you receive a health care clinic license.

This is important because Florida law provides that an insurer is not required to pay for medical treatment that is not lawfully provided. The plain language of the Act makes clear that a claim for reimbursement made by a clinic that is not properly licensed or that is otherwise operating in violation of the Act, constitutes an unlawful charge that is deemed non-compensable and unenforceable.

Filing the application with the Agency for Health Care Administration for a health care clinic license it tedious and must be done carefully or you risk denial. Also, the applicant should not expect to receive the license expeditiously.

 

Penalties

Under the Act, it is considered theft for an entity that does not have a health care clinic license and does not meet the requirements for an exemption to submit a charge for reimbursement. You can be charged with committing a third-degree felony if you operate an unlicensed clinic. Each day that the person violates the act is considered a separate offense. If a physician who is working for a clinic knows or has reasonable cause that the clinic is operating without a license and fails to report the clinic then that physician will be reported to the medical board for failure to report the clinic. There will also be administrative penalties imposed upon those who practice without a license.

 

Conclusion

A clinic is required to register for a license under the Act even if they were previously exempt from licensure requirements prior to the physician’s death unless some other applicable exemption exists. A sole health care provider should create a plan for succession in the event of their death. For example, upon the physician’s death the shares of the practice can “automatically” transfer to another physician of their choosing so that there isn’t a gap in care to patients. This would require careful planning and legal considerations beforehand. Our firm is well equipped with knowledgeable and experienced health law attorneys who can assist you with planning for this difficult event.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

 

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

Can a Physical Therapist or Chiropractor “Opt-Out” of Medicare?

Photo courtesy of Chiropractic Natural Care Center

As of November 1, 2019,  a physical therapist or chiropractor,  are unable to “opt-out” out Medicare. If you look at this chart you will see that physical therapists and chiropractors are not listed as providers who are able to opt out. The Medicare Benefit Policy Manual: Chapter 15 Section 40.4 states Physical therapists in independent practice and occupational therapists in independent practice cannot opt out because they are not within the opt out law’s definition of either a “physician” or “practitioner”. A non-opt-out provider, is required to submit a claim for any item or service that is, or may be, covered by Medicare.

The only situation in which they are not required to submit claims to Medicare for covered services is where a beneficiary or the beneficiary’s legal representative refuses, of his/her own free will, to authorize the submission of a bill to Medicare.

In some circumstances, a non-opt-out provider is required to provide an Advance Beneficiary Notice of Noncoverage (ABN) to the beneficiary prior to rendering an item or service that is usually covered by Medicare but may not be covered in this particular case. The ABN notifies the beneficiary that Medicare will likely deny the claim and prompts the beneficiary to choose whether or not he/she will accept liability for the full cost of the services if Medicare does not pay. The beneficiary also indicates on the ABN whether or not a claim should be submitted to Medicare. Providers and suppliers must follow the beneficiary’s directive for claim submission as indicated on the ABN. Providers and suppliers will not violate the mandatory claim submission rules of §1848(g)(4) of the Social Security Act when a claim is not submitted per a beneficiary’s written request on an ABN. Where a valid ABN is given and a claim is submitted, subsequent denial of the claim relieves the non-opt-out physical therapist of the limitations on charges that would apply if the services were covered. If you are providing services that are never covered by Medicare it is not mandatory for your to provide Medicare beneficiaries with ABNs for these services but you should create your own written notice informing them of the costs for service and the fact that Medicare will not cover any part of those costs.

Photo courtesy of Miami Neurology & Rehabilitation Specialists

Photo courtesy of Miami Neurology & Rehabilitation Specialists

Because Medicare’s rules do not apply to items or services that are categorically not covered by Medicare, a private contract is not needed to furnish such items or services to Medicare beneficiaries, and Medicare’s claims filing rules and limits on charges do not apply to such items or services. For example, because Medicare does not cover hearing aids, a physician or practitioner, or other supplier may furnish a hearing aid to a Medicare beneficiary and would not be required to file a claim with Medicare; further, the physician, practitioner, or other supplier would not be subject to any Medicare limit on the amount they could collect for the hearing aid. If the item or service is one that is not categorically excluded from coverage by Medicare, but may be non-covered in a given case (for example, it is covered only where certain clinical criteria are met and there is a question as to whether the criteria are met), a non-opt-out physical therapist or chiropractor is not relieved of his or her obligation to file a claim with Medicare.

If you have no relationship with Medicare, meaning that you are not enrolled as a “Participating Provider” nor as a “Non-Participating Provider” it would only be acceptable to accept self-payments from a Medicare Beneficiary if it is a for a service that would not be covered by Medicare (i.e. not reasonable and medically necessary) or if a beneficiary or the beneficiary’s legal representative refuses, of his/her own free will, to authorize the submission of a bill to Medicare.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

Establishing A Mobile IV Therapy Clinic in Florida

Recently, I’ve received several inquiries from doctors, nurses and healthcare entrepreneurs who are considering opening mobile intravenous therapy clinics throughout Florida but have some legal concerns. In the past, there weren’t many Florida laws enacted to significantly regulate IV therapy clinics whether mobile or not and not much has changed over the years. Florida doesn’t have corporate practice of medicine limitations which is attractive for many of these individuals.

What is Intravenous Therapy?

The administration of intravenous (“IV”) therapy is defined as the therapeutic infusion and/or injection of substances (i.e. supplements, vitamins and minerals) through the venous peripheral system, consisting of activity which includes observing, initiating, monitoring, discontinuing, maintaining, regulating, adjusting, documenting, planning, interviewing and evaluating. It involves the administration of medication through a needle or catheter. It is believed by some that delivering medication directly into the bloodstream can help to quickly manage a patient’s pain or symptoms. In addition to treating illnesses, IV therapy proponents claim that it may also increase athletic performance, reduce jet lag, build immunity or help with dehydration by using vitamins and minerals. According to several practitioners, IV therapy should be customized for each patient’s needs to maximize results.

What is a Mobile IV Therapy Clinic?

A license issued by the Agency for Healthcare Administration (“Agency”) is required to operate a clinic in Florida. Each clinic location must be licensed separately regardless of whether the clinic is operated under the same business name or management as another clinic. In Florida, a clinic is an entity where health care services are provided to individuals and which tenders charges for reimbursement for those services, including a mobile clinic and a portable equipment provider. A mobile clinic means a movable or detached self-contained health care unit within or from which direct health care services are provided to individuals. Each mobile clinic must obtain a separate healthcare clinic license and must provide to the Agency, at least quarterly, its projected street location to enable the agency to locate and inspect the clinic.

Additionally, a home infusion therapy provider must be licensed as a home health agency or nurse registry. Nurse registries can refer nurses to patients to provide home infusion therapy. “Home infusion therapy provider” means an organization that employs, contracts with, or refers a licensed professional who has received advanced training and experience in intravenous infusion therapy and who administers infusion therapy to a patient in the patient’s home or place of residence. “Home infusion therapy” means the administration of intravenous pharmacological or nutritional products to a patient in his or her home.

A healthcare professional licensed as an acupuncturist, medical doctor, osteopathic doctor, nurse, midwife, speech pathologist, occupational therapist, physical therapist and others, whether or not incorporated, are exempt from the licensure requirements of Florida Statute 400.464 if they are acting alone within the scope of his or her professional license to provide care to patients in their homes.

The application for a healthcare clinic license must include information pertaining to the name, residence and business address, phone number, social security number and license number of the medical or clinic director of the licensed medical providers employed or under contract with the clinic.

Who Can Provide IV Therapy?

Most Florida licensed medical doctors, osteopathic doctors, dentists, registered nurses, medical assistants, and licensed practical nurses may provide iv therapy to patients if they possess the appropriate certifications and training. Several of these practitioners must complete a required 30-hour IV certification course. Regardless of who you hire to provide IV therapy they should have several years of experience with administering IVs.

1. Emergency Medical Technicians and Paramedics

Some have inquired about the appropriateness of hiring an emergency medical technician (“EMT”) or a paramedic to administer IV therapy to the clinic’s patients. Florida law makes a clear distinction between what types of services an EMT and paramedic may provide. An EMT is defined as a person who is certified by the Department of Health to perform “basic life support”. A paramedic is defined as someone who is certified by the DOH to provide basic and advanced life support. Paramedics hold a certificate of successful completion in “advanced cardiac life support” from the American Heart Association (“AHA”) or its equivalent, whereas EMTs are only required to hold a current AHA cardiopulmonary resuscitation course card. This distinction between basic and advanced life support is important. Florida law states that Advanced life support means assessment or treatment by an appropriately qualified individual to use techniques such as endotracheal intubation, the administration of drugs or intravenous fluids, cardiac monitoring and cardiac defibrillation. Basic life support means the assessment or treatment by a person qualified to use techniques as described in the EMT-Basic National Standard Curriculum or the National EMS Education Standards of the USDOT, which includes the administration of oxygen and other techniques. The DOH has taken action against several IV clinics, which were identified as posing a potential health threat to Florida’s residents and visitors. DOH investigators have issued several cease and desist notices to paramedics and EMTs for operating outside their scope of practice for practicing medicine without the proper license.

2. Medical Assistants

Medical Assistants involved in the performance of IV therapy must receive training and certification in IV procedures. All IV therapy provided by a medical assistant must be done under direct supervision of a practitioner who is trained and has experience in the administration, potential side effect and complications related to IV therapy. If services are provided in an office setting (or mobile clinic) the experienced practitioner should always present in the office whenever a medical assistant is providing IV therapy to a patient. In a Florida Board of Medicine case, the Board held that medical assistants may lawfully perform IV infusion therapy as long as it is performed under the direct supervision and responsibility of a Florida licensed physician that is always present in the office whenever a medical assistant is providing the therapy to a patient.

3. Licensed Practical Nurses

Aspects of IV therapy may be outside the scope of practice of a licensed practical nurse (“LPN”) unless under the direct supervision of the registered professional nurse or physician and which shall not be performed or initiated by the LPN without direct supervision include the following:

          • Initiation of blood and blood products;
          • Initiation or administration of cancer chemotherapy;
          • Initiation of plasma expanders;
          • Initiation or administration of investigational drugs;
          • Mixing IV solution;
          • IV pushes, except heparin flushes and saline flushes.

With the exception of those aspects of IV therapy deemed outside the scope of practice of the LPN, and subject to the approval of the institution at which the LPN is employed, any LPN who meets the competency knowledge requirements is authorized to administer intravenous therapy under the direction of a registered professional nurse. “Under the direction of a registered professional nurse” means that the registered professional nurse has delegated IV therapy functions to a qualified LPN. The registered professional nurse does not in all instances have to be on the premises in order for the licensed practical nurse to perform the delegated functions. Direct supervision means on the premises and immediately physically available. Only license practical nurses that have met the education and competency requirement in state nursing rules can provide infusion therapy.

Who Pays for IV Therapy?

The overwhelming majority of mobile IV therapy patients will be self-pay. Medicare, Medicaid and commercial payors typically won’t cover the costs for these treatments. However, I have seen reports where commercial payors may utilize specific per diem codes to pay certain infusion providers for services, supplies and equipment. Medicare has limited coverage for home infused drugs under the Part B and Part D benefit when it is medically justified.

Other Considerations

As a medical provider you must anticipate that medical emergencies may emerge even during the most routine situations. Providers should have adequate insurance coverage for claims arising out of injury to or death of a patient and damage to the property of others resulting from any cause for which the owner of the mobile IV clinic would be liable. In lieu of malpractice insurance, a provider may furnish a certificate of self-insurance as evidence that the provider has established adequate self-insurance to cover these types of risks.

Because IV injection involves direct access into the patient’s circulatory system, sterile equipment and sterile technique must be used to avoid the introduction of any pathogens into a patient’s bloodstream. The practitioner must inspect vials for signs of contamination such as particulate matter, cloudiness, or inappropriate color. The practitioner must use a sterile alcohol wipe to cleanse the top of the vial and withdraw the fluid form the vial using a sterile needle and a sterile syringe. Practitioners must follow Universal Precautions, as described by the Occupational Safety and Health Standards (“OSHA”). To ensure safe and proper administration of infusion drugs you should consider providing some of the following services:

      • Patient Assessment
      • Drug interaction monitoring
      • Patient education
      • Patient monitoring
      • Car planning
      • Maintenance of storage, preparation, dispensing and quality control of all infusion medications and equipment.

I would advise against treating individuals under the influence of alcohol, suffering from congestive heart failure, history of aneurysms, kidney or renal disease and high blood pressure. Patients should also be 18 or older and valid written consent forms should be signed by every patient.

You must have a medical director who is employed or contracted by the clinic licensee and who provides medical supervision, including appropriate quality assurance but not including administrative and managerial functions, for daily operations and training. Additionally, a health care practitioner may not serve as the clinic director if the services provided at the clinic are beyond the scope of that practitioner’s license.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services, please contact me using the contact information listed above.

All information and references made to laws, rules, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

IV Hydration Masterclass: Legal Requirements of Starting an IV Hydration Business

Can I become a Federally Qualified Health Center?

Federally Qualified Health Centers (“FQHC”) are community-based healthcare providers that receive money for providing primary care services to under-served populations or areas. FQHCs were enacted under Section 1861(aa) of the Social Security Act and was amended by Section 4161 of the Omnibus Budget Reconciliation Act of 1990.

FQHCs are required to adhere to certain criteria, including, but not limited to, providing comprehensive healthcare services (either on-site or by arrangement with another provider) on a sliding fee scale based on ability to pay and operating under a governing board that includes patients. These comprehensive services may include: (1) preventive health services; (2) dental services; (3) mental health and substance abuse services; (4) Transportation services necessary for adequate patient care; and (5) hospital and specialty care. FQHCs must also implement an ongoing quality assurance program.

 

FQHC Certification

To be certified as an FQHC, a healthcare provider must meet one of the following requirements:

  • Receive a grant under Section 330 of the Public Health Service Act (“PHS Act”) or receive funding from such a grant and meets other requirements.
  • Is not receiving a grant under Section 330 of the PHS Act but is determined by the Secretary of the Department of Health & Human Services to meet the requirements for receiving such a grant based on the recommendation of the Health Resources and Services Administration (“HRSA”).
  • Was treated by the Secretary of HHS for purposes of Medicare Part B as a comprehensive Federally-funded health center as of January 1, 1990.
  • Is operating as an outpatient health program or facility of a tribe or tribal organization under the Indian Self-Determination Act or as an urban Indian organization receiving funds under Title V of the Indian Health Care Improvement Act as of October 1991.

 

For certification as an FQHC, the entity must meet all of these requirements:

  • Provide comprehensive services and have an ongoing quality assurance program
  • Meet other health and safety requirements
  • Not be concurrently approved as a Rural Health Clinic.

 

FQHC Eligibility

Once eligible, FQHCs will qualify for funding under Section 330 of the Public Health Service Act, as well as, enhanced reimbursement form Medicare and Medicaid. FQHCs are paid based on the FQHC Prospective Payment System (“PPS”) for medically-necessary primary health services and qualified preventive health services furnished by a FQHC practitioner.

 

Examples of FQHC

A FQHC visit is medically-necessary face-to-face medical or mental health visit or a qualified preventive health visit between the patient and a physician, NP, PA, CNM, CP, or CSW during which time one or more qualified FQHC services are furnished.  FQHCs include:

  • Community health centers
  • Migrant health centers
  • Healthcare for the homeless health centers
  • Health centers for residents of public housing
  • Health center program “look-alikes”

 

Telehealth Services

FQHCs are authorized to serve as an originating site for telehealth services if the FQHC is located in a qualifying area. An originating site is the location of an eligible Medicare patient at the time the service being furnished via a telecommunications system occurs. FQHCs that serve as an originating site for telehealth services are paid an originating site facility fee.

FQHCs are not authorized to serve as a distant site for telehealth consultations. A distant site is the location of the practitioner at the time the telehealth service is furnished. The cost of a visit may not be billed or included on the cost report.

 

FQHC Reimbursements

FQHCs set their own charges for the services they provide and determine which services to include in the bundle of services associated with each FQHC code. Charges must be uniform for all patients.

Payment is for professional services only. Laboratory tests and the technical component of billable visits are paid separately. Procedures are included int eh payment of an otherwise qualified visit and are not separately billable. If a procedure is associated with a qualified visit, include the charges for the procedure on the claim with the visit.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services please contact me using the information listed above.

All of the information and references made to laws, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

Reinstatement After A Healthcare Entity or Individual is Placed on the OIG and Florida’s Exclusion List

What is the Exclusion List?

The Office of Inspector General’s (“OIG”) list of Excluded Individuals and Entities (“LEIE”) provides information to the healthcare industry, patients and the public regarding individuals and entities currently excluded from participation on in Medicare, Medicaid and all other Federal healthcare programs.

OIG imposes exclusions under the authority of sections 1128 and 1156 of the Social Security Act. On May 8, 2013, the OIG released a Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs, which states that no federal healthcare program payment may be made for items or services furnished by (1) an excluded person or (2) at the medical direction or on the prescription of an excluded person.

 

What is the Administrative Process for LEIE?

When an individual or entity gets a “Notice of Intent to Exclude” (“NOI”), it does not necessarily mean that they will be excluded. OIG will carefully consider all material provided by the person who received the NOI before making a decision. All exclusions implemented by OIG may be appealed to an HHS Administrative Law Judge (“ALJ”), and any adverse decision may be appealed to the HHS Department Appeals Board (“DAB”). Judicial review in Federal court is only available after a final decision by the DAB.

If the OIG decided to proceed with exclusion, they will send the individual or entity a Notice of Exclusion along with information about the effect of the exclusion and appeal rights. Exclusions are effective 20 days are the Notice of Exclusion is mailed, and notice to the public is provided on OIG’s website.

When a permissive exclusion (discussed below) is being considered, the NOI allows the individual or entity to request an opportunity to present oral argument to an OIG official before a decision about whether to exclude is reached. This is in addition to the right to submit documentary evidence and written argument. The process and requirements vary depending on which section of the Social Security Act is violated.

 

How do I determine if I’ve been placed on the list?

The following are two options available to determine whether you are on the LEIE:

  1. The Online Searchable Database enables users to enter the name of an individual or entity and determine whether they are currently excluded. If a match is made on an individual, the database can verify with an individual’s Social Security Number that the match is unique. Employer Identification Numbers are available for verification of excluded entities.

 

  1. The Downloadable Database enables users to download the entire LEIE to a personal computer. Supplemental exclusion and reinstatement files are posted monthly to the OIG’s website, and these files can be merged with the previously downloaded data file to update the list.

The OIG recommends that you check the exclusion list on a monthly basis. Monthly checks should be documented so that an organization can demonstrate that they have acted in good faith to screen against excluded individuals or entities. Both databases are updated by the middle of each month. You can search here: https://exclusions.oig.hhs.gov/

Providers must also review Florida’s exclusion database while it is performing background searches.

 

Are there different types of exclusion?

There are two types of exclusions under the Social Security Act:

  1. Mandatory Exclusion – The OIG is required by law to exclude from participation in all federal healthcare programs individuals and entities convicted of the following criminal offenses: Medicare or Medicaid fraud, as well as any other offenses related to the delivery of items or services under Medicare, Medicaid, SCHIP, or other state healthcare programs; patient abuse or neglect; felony convictions for other healthcare related fraud, theft, or other financial misconduct; and felony convictions relating to the unlawful manufacture, distribution, prescription, or dispensing of controlled substances.

 

  1. Permissive Exclusion – The OIG has discretion to exclude individuals and entities on a number of grounds including, but not limited to, misdemeanor convictions related to healthcare fraud other than Medicare or a state health program; fraud in a program (other than a healthcare program) funded by any federal, state, or local government agency; misdemeanor convictions relating to the unlawful manufacture, distribution, prescription, or dispensing of controlled substances, suspension, revocation, or surrender of a license to provide healthcare for reasons bearing on professional competence, professional performance, or other financial integrity; provision of unnecessary or substandard services; submission of false or fraudulent claims to a federal healthcare program; engaging in unlawful kickback arrangements; defaulting on a health education loan or scholarship obligation; and controlling a sanctioned entity as an owner, officer, or managing employee.

For all proposed mandatory exclusions lasting longer than the mandatory minimum five-year period, and most proposed permissive exclusions the administrative process is the same. OIG will send out a written NOI to any individual that they are considering excluding. The NOI included the basis for the proposed exclusion and a statement about the potential effect of an exclusion.

If you’ve already hired someone or contracted with a vendor prior to discovering that they are on the LEIE you may be required to Self-Disclose the hiring.

 

Reinstatement from the LEIE

Reinstatement of an excluded individual or entity is not automatic once the specified period of exclusion ends. In order to participate in Medicare, Medicaid, and all Federal healthcare programs once the term of exclusion ends, the individual or entity must apply for reinstatement and receive written notice from OIG that reinstatement has been granted.

An individual or entity with a defined period of exclusion (e.g., 5 years) may begin the process of reinstatement 90 days before the end of the period specified in the exclusion notice letter.

An individual or entity excluded under section 1128(b)(4) of the Social Security Act, whose period of exclusion is indefinite, may apply for reinstatement when they have regained the license referenced in the exclusion notice. In addition, under some conditions an individual or entity excluded under section 1128(b)(4) or the Act may apply for reinstatement if they have (1) obtained a different healthcare license in the same state; (2) any healthcare license in a different state; or (3) have been excluded for a minimum period of 3 years.

To apply for reinstatement, an excluded individual or entity must send a written request to the OIG. If the individual is eligible to apply for reinstatement, the OIG will then mail Statement and Authorization forms that must be completed. Once the information have been evaluated, a written notification of OIG’s final decision on reinstatement will be provided via mail. If reinstatement is denied, the excluded individual or entity is eligible to reapply after one year.

Individuals and entities who have been reinstated are removed from the LEIE.

Penalties for Excluded Individuals or Entities

OIG may impose civil monetary penalties of up to $10,000 for each item or service furnished by the excluded person for which federal program payment is sought. They may also be forced to pay treble damages and program exclusion.

An excluded person may be civilly liable under the False Claims Act for knowingly presenting or causing to be presented a false or fraudulent claim for payment. Violations could also lead to criminal prosecutions if an excluded person knowingly conceals or fails to disclose any action affecting the ability to receive any benefit or payment with the intent to fraudulently receive such benefit or payment. Additional criminal statutes may also apply to such violations.

The information above only scratches the surface of dealing with LEIE issues. Depending on the facts of your case the circumstances, procedures, and potential outcome can vary greatly. If you have received an NOI, discovered that one of your contractors or employees is on the LEIE, or you have been excluded from receiving Federal program dollars and desire to be reinstated you should contact us immediately. We have experienced Health Law attorneys on staff who can help you navigate the entire process.

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It should be noted that I am not your lawyer (unless you have presently retained my services through a retainer agreement). This post is not intended as legal advice, it is purely educational and informational, and no attorney-client relationship shall result after reading it. Please consult your own attorney for legal advice. If you do not have one and would like to retain my legal services please contact me using the information listed above.

All of the information and references made to laws, regulations, and advisory opinions were accurate based on the law as it existed at this time, but laws are constantly evolving. Please contact me to be sure that the law which will govern your business is current. Thank you.

 

Healthcare Provider Marketing and Management Arrangements

Healthcare providers interested in entering into marketing or management arrangements with companies must structure these arrangements in such a way that they don’t violate any federal or Florida healthcare laws. Providers should avoid entering into any marketing and management arrangements, which gives the impression that they offered, paid, or solicited cash, or any other type of remuneration in exchange for referring patients to that provider. Failure to do so may result in an Anti-Kickback violation if the arrangement does not fit squarely within an Ant-Kickback Statute Safe Harbor.

Safe harbors that might be available to a healthcare provider, depending on the terms of the marketing or management arrangement, include, but, are not limited to the (1) referral; (2) personal services and management contract; and (3) referral arrangements for specialty services.

Providers may want to consider establishing relationships with lead generation companies for advertising purposes, rather than referral arrangements with marketing companies because they typically face less scrutiny than the latter.

Any payments made to the marketing and management companies must be for fair market value for the services that will be provided. Payments to the management and marketing companies must not fluctuate based upon the expectation or referrals or business that will be paid in whole or in party by a federal healthcare program.Percentage-based arrangements are looked at unfavorably by regulators and face significant scrutiny. Therefore, it is always safer to agree to fixed-fee or flat-fee (non-variable) compensation for management and marketing services.

Many providers believe that if they are not paying the management company directly that they are safe from potential liability. That is simply not true. Especially if the marketing or management company is also the owner of a healthcare clinic that benefits from the arrangement. These types of relationships look highly suspect. Providers must not enter into any contract with a practice management company if that management company receives any financial incentives form the referring provider for increasing outside referrals for designated healthcare services.

This informational article provides a brief overview of factors to consider prior to entering into these types of arrangements. However, there are many additional factors to consider. At Jones Health Law we careful scrutinize all potential marketing and/or marketing arrangements that our clients are contemplating. We counsel our clients on structuring the arrangement in such a way that it fits within an Ant-Kickback Statute Safe Harbor or an exception to the Stark Law (i.e. “Fair market value compensation” or “indirect compensation arrangement”). Further, we analyze whether the proposed arrangement could potentially violate any additional Health Law, business law, or agency rules. Additionally, we will help you draft a marketing and management agreements that best suits your needs.

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IV Hydration Masterclass: Legal Requirements of Starting an IV Hydration Business

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