Health and Safety laws are regulated by various agency officials and theses are arguably the most crucial jobs in our community. Most people do not take the time to adequately research their healthcare providers prior to receiving healthcare services or medication. However, several agencies have been established to safeguard and regulate the health and safety of the healthcare services that consumers receive. These agencies can’t replace individual due diligence but they make every attempt to prevent patient harm and to eliminate fraudulent activity in the healthcare system.
Florida Department of Health
The Florida Department of Health (DOH) was the first accredited public health system in the United States. Their mission is to protect and improve on the health of all people in Florida by regulating healthcare practitioners and facilities. They offer programs and services for the Florida community, but they are also responsible for the licensing and regulation of various healthcare practitioners and facilities. Various healthcare professions must be licensed and are regulated via the Florida Department of Health such as: medical doctors, acupuncturist, optometrists, and many more. Certain facilities such as piercing salons and pharmacies are also regulated by the Department of Health. Complaints can be filed against any of the practitioners or facilities, which will then be investigated by an officer for violations. The complaint is referred over to the Probably Cause Panel, which will determine whether to file an Administrative Complaint against the healthcare provider based on the weight of the evidence that is provided by the complainant and the provider who under investigation. It is not uncommon for the DOH to place an emergency restriction on a provider’s license if they pose an imminent danger to patient safety. If a violation is found, the Department of Health will determine appropriate disciplinary action to enforce the regulations, which includes, probation, suspension, or even revocation of a healthcare provider’s license.
Agency for Health Care Administration
The Agency for Health Care Administration (“AHCA”) was established in Florida to regulate the Medicaid system and healthcare providers who offer services to Medicaid beneficiaries. AHCA administers background screening, compiles healthcare data, and monitors the quality of care and civil rights complaints within healthcare facilities. They also license various healthcare facilities throughout Florida such as assisted living facilities, health care clinics, home health agencies, and many more.
Department of Health and Human Services
The Department of Health and Human Services has a family of agencies to provide services on local levels through state and county agencies. Some of these agencies include:
These are just a few of the hundreds of agencies established to protect our communities from safety and health emergencies. Each agency regulates their own sections within each community or program.
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.
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:
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:
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.
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.
If you’re reading this article it’s probably because you or your medical office has received a letter from a Zone Program Integrity Contractor (“ZPIC”) for The Centers for Medicare & Medicaid Services (“CMS”) alleging that you may have improperly billed Medicare for the provision Medicare Services to your patients.
What is a ZPIC?
There are seven ZPIC zones. It is possible for providers to hear from more than one ZPIC since the seven ZPICs focus on different aspects of the Medicare program. ZPIC Zone 7 includes Florida, Puerto Rico, and the U.S. Virgin Islands in its geographic scope. The Zone 7 – Zone Program Integrity Contractor was established to identify, research, and investigate cases of Medicare Program fraud relating to Parts A and B, DMEPOS, home health and hospice, and claims for dually eligible Medicare and Medicaid recipients. Fraud may include:
ZPICs responsibilities include reviewing the accuracy and justification of all services reimbursed by the program, and if necessary, take action to ensure any inappropriate Medicare payments are recovered.
Periodically ZPICs are required to conduct reviews of providers to ensure that Medicare claims have been appropriately billed. Occasionally, a ZPIC may determine based on an analysis of your claims data that you may be billing inappropriately for services. Once that determination is made, the ZPIC will begin its investigation to determine whether you have in fact billed inappropriately.
How does the ZPIC investigate?
ZPICs may conduct announced or unannounced on-site inspections at which time they will retrieve certain Medicare beneficiary records and other related business records. ZPICs will provide a list of affected Medicare beneficiaries and you will be required to produce documentation that supports the billed services, including, but not limited to:
During or after the on-site visit ZPICs may: (1) interview certain members of your staff; (2) perform a medical review; (3) Determine the need for administrative actions, such as payment suspensions and prepayment or auto-denial edits; (4) interview beneficiaries and/or (5) refer your case to law enforcement.
Law enforcement includes the OIG, FBI, or the U.S. Attorney’s Office. Prior to alerting law enforcement, ZPICs are required to take all other appropriate administrative actions. In some cases, law enforcement agency may not prosecution due to lack of evidence, insufficient, etc.
ZPICs will also look to determine whether the provider received prior audits or provided educational letters in the past by other CMS contractors.
Once the ZPIC has collected and analyzed enough data that has been obtained from the provider, they will determine whether the information indicates billing error or something more sinister such as Medicare fraud, waste or abuse. If ZPICs determine that no fraud has occurred then they will normally treat the matter as an overpayment and close the case. The ZPIC will then refer the matter to the Medicare Administrative Contractors (“MAC”) for further administrative action. Examples of administrative action include the following:
There is a significant chance that one or more of your claims will be audited in the future by a ZPIC. ZPICs have been aggressively reviewing and investigating provider and supplier medical records to identify improper billing and payments. Most providers and suppliers are identified for audit and/or investigation through an analysis of their billing practices. Our firm recommends that you consult with an experienced Healthcare Attorney if you are being audited by CMS’s Zone Program Integrity Contractors or if you have been placed on any type of corrective action. Contact us so that we can create a defense against the allegations while ensuring that you comply with the audit investigation.