FLORIDA BOARD OF NURSING RULE DEVELOPMENT WORKSHOP

The Department of Health, Board of Nursing has given notice of an upcoming Rule Development Workshop.  On July 1, 2023, a new law went into effect that amended Florida Statutes 400.211, 400.23, 464.0156, and 464.2035.  Chapter 400 of the Florida Statutes regulates nursing homes and Chapter 464 regulates the practice of nursing.

The legislature created a new designation of “qualified medication aide” (QMA) for certified nursing assistants (CNA) who work in a nursing home and meet specified additional licensure and training requirements. With this new law, a nursing home is authorized to allow a registered nurse (RN) working in the nursing home to delegate medication administration and associated tasks to a QMA who is working under the direct supervision of the RN.  Prior to the new law, CNAs were authorized to administer oral, transdermal, ophthalmic, otic, rectal, inhaled, enteral, or topical prescription medication to a patient of a home health agency or to a patient in a county detention facility.  This new law has now authorized administration of the above medications and associated tasks by a QMA, except for rectal and enteral, to a resident in a nursing home facility.

In order to be designated as a QMA, a CNA must hold a clear and active certification as a CNA for at least one year preceding the delegation; complete 40 hours of training that consists of the six-hour training course currently required for a CNA to administer medication in a home health setting and a 34-hour course developed by the Board of Nursing (BON) specific to QMAs; and successfully complete a supervised clinical practice in medication administration conducted in the nursing home.
The Board proposes that the following Florida Administrative Code Rules will require amendment to implement the statutory changes:

Chapter 14: Delegation to Unlicensed Assistive Personnel
Rule 64B9-14.0015 Delegated Tasks

Chapter 15: Certified Nursing Assistants
Rule 64B9-15.001 Definitions
Rule 64B9-15.002 Certified Nursing Assistant Authorized Duties
Rule 64B9-15.0025 CNA Medication Administration
Rule 64B9-15.0026 Medication Administration Outside the Scope of Practice of a CNA

Chapter 16: LPN Supervision in Nursing Home Facilities
Rule 64B9-16.001 Definitions
Rule 64B9-16.002 Supervision by Licensed Practical Nurses in Nursing Home Facilities
Rule 64B9-16.004 Delegation of Tasks Prohibited

The Florida Health Care Association has submitted a proposed training curriculum for certification to become a QMA as well as suggestions for the revisions to the above Rules to implement the statutory changes.  The submission can be found in the public book available on the Board of Nursing’s website along with the proposed agenda at the below link.
https://floridasnursing.gov/meeting-information/

The preliminary text of the proposed rule is not available.
The workshop is scheduled for Thursday, October 26, 2023, 9:00 a.m., E.D.T., or as soon thereafter as can be heard.
Toll Free Number 1(888)585-9008, Conference Room ID: 275-112-502#

OPPORTUNITY TO PROVIDE COMMENTS TO AHCA ON MANAGED CARE PROVIDERS

Today, the Florida Agency for Health Care Administration (AHCA) announced that it is soliciting comments from health care providers regarding any issues or concerns with existing Managed Care Plan providers under the Statewide Medicaid Managed Care Program.   This is your opportunity as a health care provider directly impacted by the Medicaid Managed Care Plans to voice any problems, concerns, or suggestions.  This announcement is part of AHCA’s ongoing re-procurement  under the Statewide Medicaid Managed Care program.  AHCA will consider your comments in the process of making awards to Managed Care Organizations and Provider Service Networks in each Region of the State.   This process was mandated under a legislative amendment that requires AHCA to solicit comments.

BACKGROUND ON STATEWIDE MEDICAID MANAGED CARE PROGRAM

The State of Florida has offered Medicaid services since 1970. Medicaid is funded by both the state and federal government to provide health care coverage for eligible children, seniors, disabled adults, and pregnant women. The annual budget for the program is more than $38 billion and makes up the largest part of the total Florida budget. The 2011 Florida Legislature originally adopted the legislation (now Part IV of Chapter 409, Florida Statutes) to create and establish the Florida Medicaid program as a statewide, integrated managed care program for all covered Medicaid services, including long-term care services. This program is referred to as Statewide Medicaid Managed Care (SMMC) and includes three programs: Managed Medical Assistance (MMA), Long-term Care (LTC), and Dental. The 2022 Florida Legislature passed Senate Bill 1950 (amending part IV of Chapter 409, Florida Statutes) to reallocate Medicaid regions, direct the Agency to conduct a single statewide procurement for the SMMC program, and ensure a minimum number of managed care plans per Medicaid region. More than 4.4 million Floridians are enrolled in Florida’s SMMC program.

COMMENTS TO BE CONSIDERED IN SELECTING NEW MEDICAID MANAGED CARE PLANS AND PROVIDER SERVICE NETWORKS

Based on the 2022 legislative amendment, AHCA is not required to consider comments from health care providers that operate in an area covered by on  the existing Plans.  The Invitation to Negotiate provides:

“ a. Pursuant to Section 409.966(3)(a)8., Florida Statutes, the Agency will consider comments in writing by any enrolled or registered Medicaid provider relating to a respondent that has submitted a response to this solicitation in the same region in which the provider is located and rendering services. b. The Agency will publish a list of respondents and instructions for how providers may submit comments to this solicitation within two (2) business days of the public opening at: https://ahca.myflorida.com/procurements. c. The Agency will utilize an online survey tool for the collection of the provider comments. The online survey tool will remain open and active for a period of ten (10) business days. d. Providers must submit comments to the Agency through the published survey tool by the date/time indicated in Section A., Overview, Sub[1]Section 6., Solicitation Timeline and as outlined on the Agency’s website.

Today’s Announcement provides  that comments must be submitted no later than November 9, 2023 by 5 PM.  Comments are submitted through an on-line survey tool.  For additional information, or assistance in submitting comments, please contact us.

PROPOSED FEDERAL RULE AMENDMENT

The Department of Health and Human Services (“HHS”) and The Centers for Medicare and Medicaid Services (“CMS”)

As part of the Biden-Harris Administration’s Nursing Home Reform initiative, and because Federal nursing home staffing laws have not been updated since 1987, HHS and CMS have announced a proposed rule amendment to 42 CFR parts 438, 442, and 483 to ensure safe and quality care in long-term care facilities.  This focuses on the proposed amendments to 42 CFR 483 regarding minimum nurse staffing requirements.

  • Minimum Staffing Standards for Long-Term Care Facilities (42 CFR 483)
  • The proposed rule establishes minimum nurse staffing standards in nursing homes as follows:
    • Minimum nurse staffing standards of 0.55 hours per resident day (“HPRD”) for Registered Nurses (“RN”s).
    • HHS evaluated State nurse staffing requirements and noted that the proposed RN requirement is higher than every State and only lower than the District of Colombia based on September 2022 data.
    • Minimum of 2.45 HPRD for Nurse Aides (“NA”s).
    • HHS noted that the proposed NA staffing requirement also is higher than every State and only lower than the District of Colombia based on September 2022 data.
    • A requirement to have an RN onsite 24 hours a day, seven days a week.
  • HHS expects facilities to staff above these minimum baseline levels to address the specific needs of their unique resident population based on the facility assessment and resident acuity levels.
    • Federal regulations currently require LTC facilities to use the services of an RN for at least 8 consecutive hours a day, 7 days a week (§483.35(b)(1)).
    • The LTC facility must also designate an RN to serve as the Director of Nursing (“DON”) on a full-time basis (§483.35(b)(2)).
  • These Federal requirements specify a number of hours that these licensed nurses and other nursing personnel must be available; however, there is no requirement that those hours be specifically dedicated to direct resident care.
  • To meet these proposed new standards HHS estimates that approximately three quarters of nursing homes would have to strengthen staffing in their facilities in order to comply.  HHS is proposing options for exemptions and a staggered implementation of the proposed requirements to alleviate challenges due to the nursing workforce.
  • HHS is seeking public comments regarding the proposed rules, including viable alternatives to the proposed staffing standards that will ensure safe and quality care for the over 1.2 million residents receiving care in Medicare and Medicaid-certified LTC facilities each day.
  • Florida’s minimum staffing requirements.
  • The Florida minimum staffing requirements include “direct care staff” as defined in F.S. 400.23 (3)(a)1. a. “Direct care staff” means persons who, through interpersonal contact with residents or resident care management, provide care and services to allow residents to attain or maintain the highest practicable physical, mental, and psychosocial well-being, including, but not limited to, disciplines and professions … in the categories of direct care services of nursing, dietary, therapeutic, and mental health. The term does not include a person whose primary duty is maintaining the physical environment of the facility, including, but not limited to, food preparation, laundry, and housekeeping.
  • It must be noted that Federal rule §442.43(a)(2) defines “Direct Care Worker” in a somewhat similar fashion; however, these direct care workers are not included in the proposed minimum nurse staffing numbers.
  • Pursuant to F.S. 400.23(3)(b), the minimum staffing requirements are as follows:
    • A minimum weekly average of 3.6 hours of care by direct care staff per resident per day.
    • A minimum of 2.0 hours of direct care by a certified nursing assistant per resident per day. A facility may not staff below one certified nursing assistant per 20 residents. (It must be noted that Florida revised the CNA standard from 2.45 to 2.0 in April 2022.)
    • A minimum of 1.0 hour of direct care by a licensed nurse per resident per day. A facility may not staff below one licensed nurse per 40 residents. (It must be noted that Florida’s requirements only specify “licensed” nurse (which would include RNs and LPNs) rather than specifying an RN as required by the proposed Federal rule (which HHS purposefully proposed so that facilities do not have the flexibility to decide between types of licensed nurses to meet the minimum)).
    • Nursing assistants employed under s. 400.211(2) (reflected in Federal rule §483.35(d)(1)) may be included in computing the hours of direct care provided by certified nursing assistants and may be included in computing the staffing ratio for certified nursing assistants if their job responsibilities include only nursing-assistant-related duties.
    • Certified nursing assistants performing the duties of a qualified medication aide under s. 400.211(5) may not be included in computing the hours of direct care provided by, or the staffing ratios for, certified nursing assistants or licensed nurses.
  • Additionally, Rule 59A-4.108, Florida Administrative Code, requires the following with regard to nursing services in nursing homes:
    • There shall be a DON who shall be responsible and accountable for the supervision and administration of the total nursing services program.
    • The DON must designate one licensed nurse on each shift to be responsible for the delivery of nursing services during that shift.
  • Effect of Proposed Federal Rule to Florida LTC Facilities
  • To meet the proposed requirement that the facility have an RN on duty 24 hours a day 7 days a week:
    • HHS has estimated that Florida will require an additional 8 nurses in rural areas and an additional 21 nurses in urban areas to meet this requirement.
    • To meet the proposed requirement of 0.55 HPRD for RNs:
    • HHS has estimated that Florida will require an additional 51 RNs in rural areas and an additional 390 RNs in urban areas.
    • To meet the proposed requirement of 2.45 HPRD for NAs:HHS has estimated that Florida will require an additional 23 NAs in rural areas and an additional 414 NAs in urban areas.
  • Comment Submission for the CMS Proposed Rule.
  • There are varying staffing models that are available and different approaches that HHS could have adopted for the proposed minimum nurse staffing requirement such as separate requirements for RNs, LVNs/LPNs, and NAs or defining requirements for licensed nurse staffing, that is, combining RNs and LVNs/LPNs or creating standards for NAs only.  Alternatively, HHS could have adopted non-nurse staffing requirements such as social workers, therapists, feeding assistants and other non-nurse staffing types in the minimum staffing requirement.
  • Ultimately HHS chose the comprehensive 24/7 RN and 0.55 RN and 2.45 NA HPRD requirements to strike a balance between ensuring resident health and safety, while preserving access to care, including discharge to community-based services.
  • HHS welcomes comments, and specifically on the following questions:
    • Does your facility, or one you are aware of, have an RN onsite 24 hours a day, 7 days a week? If not, how does the facility ensure that staff with the appropriate skill sets and competencies are available to assess and provide care as needed?
    • If a requirement for a 24 hour, 7 day a week onsite RN who is available to provide direct resident care does not seem feasible, could a requirement more feasibly be imposed for a RN to be “available” for a certain number of hours during a 24 hour period to assess and provide necessary care or consultation provide safe care for residents? If so, under what circumstances and using what definition of “available”?
    • Should the DON be counted towards the 24/7 RN requirement or should the DON only count in particular circumstances or with certain guardrails? Please explain why or why not.
    • Are there alternative policy strategies that we should consider to address staffing supply issues such as nursing shortages?
    • The comment period is open for a sixty-day period that expires on November 6, 2023.  More information on how to submit comments or to review the entire rule, can be found at this link: https://www.federalregister.gov/documents/2023/09/06/2023-18781/medicare-and-medicaid-programs-minimum-staffing-standards-for-long-term-care-facilities-and-medicaid

Challenges to Bid Specifications – Don’t be Afraid to Rock the Boat!

Businesses involved in contracting with federal, state, or local government agencies as vendors or service providers are likely well aware of the complexity and detail typically included in the specifications and requirements for public contract solicitations contained in Invitations to Bid, Requests for Proposals, Invitations to Negotiate, and other similar documents. (For ease of reference I will refer to these documents as “bid solicitations” in this article.) Far too often, parties interested in responding to bid solicitations fail to timely ask questions, seek clarifications, or challenge the specifications, which can result in a waiver of the right to raise such issues later in the evaluation and contract award process. In some instances, it is simply a failure of the proposed vendor to do the tough job of plowing through the specifications to make sure that the bid solicitation is clear and unambiguous, and that their product or service can meet the specifications as written. In other instances, the proposed vendor may identify unclear terms, or worse, specifications that they may not meet, and still decide that they don’t want to “rock the boat” by raising the concerns with contracting authority.

This is a common error for businesses seeking government contracts, as most contracting authorities have strict timelines for raising problems or questions about the bid solicitation documents. The failure to do so often results in a waiver of the right to raise these issues or questions later should the vendor be disqualified as “non-responsive” or “non-responsible” or simply fail to score well in the evaluation process.

At the federal level, for example, Federal Acquisition Regulation 33.103 provides that:

(e) Protests based on alleged apparent improprieties in a solicitation shall be filed before bid opening or the closing date for receipt of proposals. In all other cases, protests shall be filed no later than 10 days after the basis of protest is known or should have been known, whichever is earlier. The agency, for good cause shown, or where it determines that a protest raises issues significant to the agency’s acquisition system, may consider the merits of any protest which is not timely filed.

Federal decisions of the General Accounting Office have rejected untimely protests noting that “[T]his view is consistent with the purpose behind our Regulations’ timeliness rule for protests alleging solicitation improprieties: i.e., to give the agency notice of the protest before bid opening or receipt of proposals, to provide an opportunity for the agency to take action before bids or proposals are prepared and submitted. Applied Controls Co., Inc., Recon., B-228568.2, Nov. 30, 1987, 87-2 CPD ¶ 528 at 1; ERA Helicopters, Inc., B-218607, Aug. 1, 1985, 85-2 CPD ¶ 114 at 2.”

In Florida, the law is clearly stated in Section 120.57(3)(b), Fla. Stat., which includes specific waiver language as follows:

(b) Any person who is adversely affected by the agency decision or intended decision shall file with the agency a notice of protest in writing within 72 hours after the posting of the notice of decision or intended decision. With respect to a protest of the terms, conditions, and specifications contained in a solicitation, including any provisions governing the methods for ranking bids, proposals, or replies, awarding contracts, reserving rights of further negotiation, or modifying or amending any contract, the notice of protest shall be filed in writing within 72 hours after the posting of the solicitation. The formal written protest shall be filed within 10 days after the date the notice of protest is filed. Failure to file a notice of protest or failure to file a formal written protest shall constitute a waiver of proceedings under this chapter.

Similar provisions are included in numerous county and municipal procurement codes and ordinances throughout Florida, as well as set forth in many bid solicitation documents expressly.

The consequences of failing to raise timely questions can be severe. Below are just a few of the many cases where a bid protest challenge was rejected for failing to timely raise the matter in a protest to the bid solicitation.

  • Soly Interiors Division of Lyons Construction Company, As Agent For Wellco Carpet Corporation, Petitioner v. Department of General Services, Division of Purchasing, Respondent., 1988 WL 616900. The record reflects that petitioner received a “bid specimen” containing the questioned item long before the ITB was issued. However, Soly did not seek clarification as to how the certification should be completed or what meaning should be ascribed to the terms “manufacturer,” “supplier” and “open account.” By failing to do so, Soly waived any objection to a lack of clarity in the special condition.
  • Capeletti Brothers, Inc. v. Department of Transportation, 499 So.2d 855, 857 (Fla. 1st DCA 1986). The failure to timely seek correction or clarification of plans and specifications constitutes a waiver of that claim.
  • Juvenile Services Program, Inc. v. Department of Juvenile Justice, DOAH Case No. 10-6280BID (DOAH 2011). In this case, it is concluded that Petitioner failed to timely challenge the terms of the RFP and thereby waived any claim that sought to challenge the specifications of the RFP.
  • Eckerd Youth Alternatives, Inc. v. Department of Juvenile Justice, DOAH Case No. 10-0535BID; Judge Susan B. Harrell. Even though it was not stated in the RFP, the calculation using an “Average” recidivism rate had been the Department’s prior policy and the proposer was aware of this and did not challenge the lack of clear methodology within 72 hours of the RFP being issued. Therefore, the issue of unclear specification was waived, and it was not arbitrary or capricious to use the long-standing prior policy.
  • Optimum Technology, Inc. v. Department of Health, DOAH Case No. 11-0275BID; Judge Robert E. Meale. DOH issued an RFP for a prescription drug monitoring system. Petitioner argued that the process was flawed because it did not include any meeting to “normalize” the scores of the evaluators to eliminate bias or arbitrary scoring. The court held such argument could only be raised within 72 hours of issuing RFP and was therefore waived.
  • Troy Foundation, Inc. v. Department of Juvenile Justice, DOAH Case No. 10-0536BID; Judge Claude B. Arrington. The RFP included a clear footnote that the specific type of program considered would be considered in evaluation of past performance. The disappointed proposer failed to raise any challenge to this specification within 72 hours of the RFP being issued, and the issue was therefore waived.

Thus, it is abundantly clear that vendors and contractors with government agencies must carefully review bid solicitations when they are issued. If there is any perceived problem with the solicitation, the potential vendor or supplier must act quickly to preserve rights to raise the issue. Vendors will be ill-served by seeking to avoid controversy with the issuing government authority or being afraid to “rock the boat.” In fact, in many instances, a party raising a challenge will be doing the procurement agency a favor by allowing the opportunity to fix a potential problem.

Some common problems in bid solicitations include:

  • Unclear or Ambiguous Terms. It has long been recognized that public agencies have a duty to write clear and unambiguous bid specification. When specifications are unclear or indefinite, potential bidders should act quickly to protest unclear provisions.
  • Biased or “Proprietary” Specifications. Specifications may intentionally or unwittingly be designed in a manner that unfairly favors or discriminates against a specific vendor. Specifications may not be drawn in a manner that would permit only one bidder to qualify. Robinson’s, Inc. v. Short, 146 So.2d 108 (Fla. 1st DCA 1962). For example, a manufacturer of truck-weighing scales was entitled to a formal administrative hearing based on its claim that the Department of Transportation had specified a static scale system that could be supplied by only one vendor. Fairbanks, Inc. v. State, Dept. of Transportation, 635 So.2d 58 (Fla. 1st DCA 1994). Mayes Printing Co. v. Flowers, 154 So.2d 859 (Fla. 1st DCA 1963) offers another illustration of an exclusionary bid.
  • Unreasonable Qualifications, References, Certifications or Experience Requirements. Use of “gatekeeper” provisions that set forth unreasonable experience, references, certifications, or other provisions to be considered qualified for the contract and that are designed to eliminate otherwise qualified bidders, products, and services from the solicitation process are certainly suspect. While a government contracting agency may have legitimate reasons for such provisions, they should not be overly restrictive nor designed to limit competition or provide an unfair advantage to one or more contractors. If a vendor can legitimately provide the product or service being sought, then restrictive provisions that serve no real purpose other than limiting legitimate competition should be challenged.
  • Use of an RFP, ITN, or Other Solicitation Method When an ITB Based Upon Price Should Be Used. Most procuring government agencies have a hierarchy that recognizes an Invitation to Bid, where lowest cost prevails, is the preferred method of government procurement since it saves taxpayers dollars and avoids “sweetheart deals.” Unfortunately, many governmental agencies gloss over the preferences in statutes, ordinances, and regulations for decision making based upon the lowest priced proposal for comparable products and services. If the products or services can be described with reasonable specificity, and the government is not looking to proposers to invent or create a new solution to a general problem, then an ITB should likely be the preferred solicitation method.

While an exhaustive discussion of all potential protests is beyond the scope of this article, any vendor should carefully review bid solicitations when issued. Any problems or questions need to be asserted in a timely manner.

For a more detailed look into bid protests, please review our article – Bid Protests – Know Your Rights.

Should you have any questions or need assistance with a bid protest, please contact an experiences bid protest attorney at Smith & Associates for a free consultation.

AHCA PROPOSED RULE CHANGES FOR NURSE REGISTRIES

AHCA Notice of Rule Changes

On August 15, 2023, the Agency for Health Care Administration (“AHCA”) published notice of a proposed rule amendment regarding Florida Administrative Code (F.A.C.) Rule 59A-18.0081 which applies to regulation of licensed Nurse Registries in Florida. A copy of the AHCA Notice of Proposed Rule Amendment can be accessed here. Licensed Nurse Registries in Florida should review the proposed changes to determine how these changes to the Rule will affect their future operations, and if there are any concerns that should be addressed prior to the Rule becoming final. Nurse Registries affected by the Rule have certain rights, as described below, to participate in a public hearing or in a formal Rule Protest proceeding to seek changes or modifications to the proposed Rule amendments.

Overview of Rule Amendments

The current Rule 59A-18.0081, F.A.C. sets forth general requirements governing Nurse Registries including Rules that set forth requirements for certified nursing assistants (“CNAs”) and home health aides (“HHAs”) who provide health care services to patients in the home or place of residence and specifies the services that a CNA or HHA can perform. The main purpose of the proposed Rule amendments is to incorporate changes based upon changes recently made to Florida Statute 400.488, “Assistance with self-administration of medication and with other tasks.” This statute was updated in 2022 to add that CNAs and HHAs may assist with other tasks other than just self-administration of medication. This Rule amendment clarifies for CNAs and HHAs what can be performed, and it also clarifies some tasks that cannot be performed.

The proposed rule amendment reflects the additional tasks that CNAs and HHAs may now perform as taught and documented by a registered nurse (“RN”). Many of the proposed changes to the rule are reorganizing the language; however, it does specify both additional tasks that are now allowed, as well as specify some tasks that are not allowed. These proposed changes will assist in clarification for CNAs, HHAs, and the RNs that supervise them. The specific rule changes that include the additional tasks are as follows (underlined additions, strike through deletions):

(a) Assisting with the placement and removal change of a colostomy bag, excluding the removal of the flange or manipulation of the stoma’s site reinforcement of dressing;
(b) Assisting with the application and removal of anti- embolism stockings and hosiery prescribed for therapeutic treatment of the legs.
(b) through (d) renumbered (c) through (e) No Change.
(f) (e) Administer Doing simple urine tests for sugar, acetone or albumin;
(g) Assisting with the use of a glucometer to perform blood glucose testing;
(h) (f) Measuring and preparing special diets;
(i) (g) Measuring intake and output of fluids; and,
(j) (h) Measuring vital signs, including temperature, pulse, respiration or blood pressure;
(k) Assisting with oxygen nasal cannulas and continuous positive airway pressure (CPAP) devices, excluding the titration of the prescribed oxygen levels; and
(l) Assisting with the reinforcement of dressing.

The proposed rule amendment regarding the tasks that cannot be performed by a CNA or Home Health Aide are as follows:

(a) Administer any nursing or therapeutic service that requires licensure as a health care professional;
(b) Change sterile dressings.
(c) Irrigate body cavities such as giving an enema;
(d) Perform irrigation of any wounds (such as vascular ulcers, diabetic ulcers, pressure ulcers, surgical wounds) or apply agents used in the debridement of necrotic tissues in wounds of any type;
(e) Perform a gastric irrigation or enteral feeding;
(f) Catheterize a patient;
(g) Administer medications;
(h) Apply heat by any method;
(i) Care for a tracheotomy tube;
(j) Provide any service which has not been included in the plan of care; or,
(k) Providing assistance with a pill organizer, such as removing medication from a pill organizer and placing the medication in the patient’s hand or filling a pill organizer with the patient’s medication(s).

Other proposed changes to the rule worth mentioning are that when it comes to assistance with self-administration of medications, previously it was required that a review of the medications for which assistance is to be provided was to be conducted by a registered nurse or a licensed practical nurse (“LPN”). The proposed rule will change this and require that an assessment of the patient and patient’s medications for which assistance is to be provided must be conducted by an RN to ensure that a patient receiving such assistance is medically stable and has regularly scheduled medications that are intended to be self-administered. This assessment may not be conducted by an LPN.

Right to Participate in Public Hearing or Formal Rule Challenge Proceedings

Prior to the adoption, amendment, or repeal of any rule other than an emergency rule, an agency such as AHCA is required to give notice of its intended action as required by Section 120.54(3)(a), Florida Statutes. The notice must be published in the Florida Administrative Register not less than 28 days prior to the intended action. Any person who will be substantially affected by a rule or a proposed rule may request a Public Hearing on the Rule changes and may seek an administrative determination of the invalidity of the rule on the grounds that the rule is an invalid exercise of delegated legislative authority pursuant to F.S. 120.56. There are strict time restraints for challenging a proposed rule that are delineated in F.S. 120.56(2) as follows:

A petition alleging the invalidity of a proposed rule shall be filed within 21 days after the date of publication of the notice required by s. 120.54(3)(a); within 10 days after the final public hearing is held on the proposed rule as provided by s. 120.54(3)(e)2.; within 20 days after the statement of estimated regulatory costs or revised statement of estimated regulatory costs, if applicable, has been prepared and made available as provided in s. 120.541(1)(d); or within 20 days after the date of publication of the notice required by s. 120.54(3)(d).

According to published Notice, a Rule Workshop on the proposed Nurse Registry rule changes is scheduled for September 14, 2023, 2:00 p.m. to 3:00 p.m. at the Agency for Health Care Administration, 2727 Mahan Drive, Building 3, Conference Room C, Tallahassee, FL 32308. Individuals may also participate by dialing the Open Voice conference line, 1(888)585-9008, then enter the conference room number followed by the pound sign, 998-518-088#. The agenda and related materials can be found on the web at:
https://ahca.myflorida.com/MCHQ/Health_Facility_Regulatio n/Rulemaking.shtml.
Any affected party may participate in the Workshop to offer comments, ask questions, or suggest modifications. Any Petition to Challenge Proposed Rule Amendments would need to be filed with the Division of Administrative Hearings within 10 days after the final public hearing is held.

Legal Standards in a Rule Challenge

In a formal hearing the Party filing a Rule Challenge has the burden to prove by a preponderance of the evidence that they would be substantially affected by the proposed rule. The Agency then has the burden of proving by a preponderance of the evidence that the proposed rule is not an invalid exercise of delegated legislative authority as to the objections raised. According to Section 120.52(8), Florida Statutes, a rule is deemed to be an “invalid exercise of delegated legislative authority” if any of the following apply:

(a) The agency has materially failed to follow the applicable rulemaking procedures or requirements set forth in this chapter;
(b) The agency has exceeded its grant of rulemaking authority, citation to which is required by s. 120.54(3)(a)1.;
(c) The rule enlarges, modifies, or contravenes the specific provisions of law implemented, citation to which is required by s. 120.54(3)(a)1.;
(d) The rule is vague, fails to establish adequate standards for agency decisions, or vests unbridled discretion in the agency;
(e) The rule is arbitrary or capricious. A rule is arbitrary if it is not supported by logic or the necessary facts; a rule is capricious if it is adopted without thought or reason or is irrational; or
(f) The rule imposes regulatory costs on the regulated person, county, or city which could be reduced by the adoption of less costly alternatives that substantially accomplish the statutory objectives.

A grant of rulemaking authority is necessary but not sufficient to allow an agency to adopt a rule; a specific law to be implemented is also required. An agency may adopt only rules that implement or interpret the specific powers and duties granted by the enabling statute.

An example of a recent finding where a rule was found to be an invalid exercise of legislative power was in Fla. Dep’t of Bus. & Pro. Regul., Div. of Alcoholic Beverages & Tobacco v. Walmart Inc., No. 1D19-4599, 2021 WL 1996361 (Fla. Dist. Ct. App. May 19, 2021), reh’g denied (Aug. 19, 2021), wherein the Court held:

Plain meaning of “restaurant” as term was used in statute governing eligibility for consumption-on-premises liquor licenses, whether term’s meaning was “public eating place” or “public food service establishment” or “business establishment where meals or refreshments may be purchased,” supported that restaurants customarily sold food prepared offsite and that restaurants were not limited to selling food prepared onsite, and, thus, rule interpreting statute and defining items “customarily sold in a restaurant” to exclude food prepared offsite was invalid for enlarging, modifying, or contravening statute.

Affected Parties Should Review the Proposed Rule Changes

Nurse Registries affected by the proposed rule amendment should review the proposed amendments carefully. If you feel there is a need for clarification, or that a rule is not warranted or is in conflict with statute, you should exercise your legal rights to participate in the Workshop and any future Public Hearing to seek modification of the proposed rule amendments, or to challenge proposed Rule amendments that may be invalid.

If you have questions or concerns about this new rule, you can contact an experienced healthcare attorney at Smith & Associates for a free consultation.

Defending Your Professional License from an Administrative Complaint

You worked hard to obtain your professional license. You also work hard to maintain your professional license. Whether it be a medical license, a nursing license, a real estate license or any of the other professional licenses issued by the Florida Department of Health or the Department of Business and Professional Regulation, these professional licenses allow you to practice your trade and earn a living.

However, if the agency or board in charge of your license has probable cause to believe your have violated a statute or rule governing your license, it can issue an administrative complaint and seek to take disciplinary action against you, including the revocation of your license.

It is important to have strong, experienced legal counsel representing you through the disciplinary process.

How Does the Process Work

The process starts when an agency or board receives a complaint about a licensed individual. These complaints can come from anyone, including your employer, law enforcement, or the general public. Once a complaint is received, the appropriate board will notify the licensed individual and begin its investigation. The complaint and any investigative materials will remain confidential during the investigation process.

The investigation is your first opportunity to address any allegations of wrongdoing. If you receive an investigation letter or a phone call from an investigator, you will be given the opportunity to explain, deny, or otherwise justify the allegations contained in the complaint. However, please note that, while this is not a criminal matter, anything you say can be used against you as the process proceeds.

After the investigation is concluded, the investigation team will present their findings to the appropriate probable cause panel who will make a determination as to whether probable cause exists to issue an administrative complaint. As this process is still confidential, you will not be informed about the result until after the panel has made its decision. If the panel finds that no probable cause exists, the matter will be closed, and the complaint and investigative materials will be kept confidential.

If the panel determines that probable cause does exist, an administrative complaint will be issued and served upon you, to your address of record, by certified mail. Once you receive an administrative complaint, time is of the essence. If you fail to timely respond within 21 days, your right to dispute the claims in the complaint may be waived.

In response to the complaint, you will have three options:

  1. Relinquish your license. Please note that, if you chose this option, it will be considered a disciplinary action and will affect your ability to obtain or renew any other professional licenses you may have in Florida and will likely have a negative affect on any professional licenses you may maintain in other states.
  2. Request an Informal Hearing. If you choose this option, you are admitting the material facts of the complaint and will be assigned an informal hearing officer who will hear your case and decide what, if any, punishment is proper. You should be very careful in choosing this option as you cannot deny the allegations in the complaint at the informal hearing.
  3. Request a Formal Administrative Hearing. This option is usually the best option to select, however you must do more than simply select the correct checkbox (e.g., you must identify the facts you believe are in dispute). If you select this option, your case will be forwarded to the Division of Administrative Hearings where an Administrative Law Judge (ALJ) will be assigned to your case. You will be given the opportunity to conduct discovery (e.g., request relevant documents and take depositions of potential witnesses) and you will be given an opportunity to defend against the allegations and present your case. Importantly, the board or department will bear the burden of proving the case by clear and convincing evidence – that means that the burden is not on you to prove you didn’t do what is alleged, but that the board must prove everything that it has alleged.

Regardless of which option you pick, a final order will eventually be issued. While the best outcome is that no action is taken against your license, the potential disciplinary actions can include the issuance of a letter of reprimand, imposition of fines and costs, the placing of restrictions upon the license, suspension of the license, or permanent revocation of the license.

Why Should I Retain an Experienced Professional Licensing Attorney

An experienced professional licensing attorney can help you through the entire disciplinary process. For example, if you receive an investigation notice, an experienced attorney can draft a legal response to the investigation. This has two benefits 1) it prevents you from accidentally revealing information to the investigator that may be harmful to your case, and 2) it helps the probable cause panel understand the factual and legal issues within the complaint. Prevailing at the probable cause panel keeps the complaint confidential and prevents the need to go through the formal administrative hearing process.

Further, if an administrative complaint is issued, the board or department will be represented by its own attorneys. Having an experienced attorney fighting for you levels the playing field and helps ensure that you are able to put on your best defense. Additionally, an experienced professional licensing attorney can negotiate a reasonable settlement of the complaint early in the process to avoid the costs and expenses of a full administrative hearing.

If you have been notified that you are being investigated related to your professional license or if you have received an administrative complaint related to your professional license, you can contact an experienced professional licensing attorney at Smith & Associates for a free consultation.

Operation Nightingale – DOH is Issuing Administrative Complaints

As discussed in a prior article, following an investigation into six Florida schools accused of engaging in a scheme to sell fraudulent nursing degrees, diplomas, and transcripts, the State of Florida, Department of Health has begun investigating nurses that it believes obtained these fraudulent degree.

Now, DOH is moving forward with the issuance of administrative complaints. If you have received an administrative complaint, know that you must strictly comply with the time periods included in the Election of Rights. If you want to contest DOH’s complaint, you must timely elect to have a formal administrative hearing and file a petition for the same.

What is most concerning is that the students of these colleges, which were accredited by DOH, had no idea that there was any fraudulent activity going on. They attended classes, took exams, and performed their clinical hours as required by the accredited schools. DOH reviewed all of this prior to issuing the nursing licenses and still issued the license.

DOH is attempting to come back and re-review the licenses due to errors committed, not by the nurses, but by DOH and the schools at issue. This is not proper.

In fact, DOH attempted to do something similar to this in the past and it was rejected by administrative law judges. In those cases, an accredited massage therapy school incorrectly informed certain students that they could transfer credits from another school and other incorrect statements about what was necessary to get their degree. These students were unaware that these statements were in error and followed the school’s requirements and had their degrees and transcripts issued, following which they applied for and were granted massage therapy licenses.

When DOH recognized its error, it brought claims under the same statutes that it is bringing claims against students affected by Operation Nightingale. The administrative law judges presiding over these cases rejected these claims by DOH. In particular, Administrative Law Judge Van Laningham stated:

The Department takes the position that Peng’s license can be revoked based on the Department’s unilateral mistake, even if Peng did not personally commit a culpable act. Thus, the Department contends that because its staff missed several so-called “red flags” that “should have caused them to ask additional questions regarding [Peng’s] application,” Peng herself committed a disciplinable offense. This argument is rejected.

To begin, the Department’s “unilateral error” theory is inconsistent with the general procedure for licensing as set forth in section 120.60, which provides in pertinent part as follows:

(1) Upon receipt of an application for a license, an agency shall examine the application and, within 30 days after such receipt, notify the applicant of any apparent errors or omissions and request any additional information the agency is permitted by law to require. An agency shall not deny a license for failure to correct an error or omission or to supply additional information unless the agency timely notified the applicant within this 30-day period.

Given that the law unambiguously prohibits an agency from “deny[ing] a license for failure to correct an error or omission or to supply additional information unless the agency timely notified the applicant” of the particular deficiency within 30 days after receiving the application, to allow the agency later to revoke a license pursuant to section 456.072(1)(h) based solely on a purported deficiency or “red flag” in the licensee’s application of which the agency failed to give timely notice under section 120.60 not only would erode the protection that the latter statute affords specific licensees, but also would undermine the integrity of licenses in general.

Further, section 456.072(1) clearly does require a culpable ““act” on the part of the licensee as a condition for imposing discipline. Id. (“The following acts shall constitute grounds for” discipline) (emphasis added). The disciplinable acts specified in section 456.072(1)(h) are the use of a bribe, fraudulent misrepresentation, or “error of the department” to obtain a license.

Because a unilateral agency error does not involve any wrongful act on the licensee’s part, such an event cannot constitute a basis for discipline. For a disciplinable act to occur, the applicant must somehow use or take advantage of an agency error to obtain her license.

The full order can be accessed here.

DOH is seeking to hold innocent students responsible for its own mistakes and failures. Hopefully, the judges will continue to rule as they did in the above cited case and reject DOH’s attempt to relitigate the original issuance of the licenses.
If you have been issued an investigation letter or administrative complaint by the DOH regarding Operation Nightingale, you should contact an experienced attorney at Smith & Associates to discuss your rights and options.

AHCA Has Released the SMMC ITN

AHCA has now released the Invitation to Negotiate (“ITN”) for the new Statewide Medicaid Managed Care contracts. Importantly, AHCA has set the following key deadlines:

  • Deadline for receipt of written questions is May 3, 2023.
  • The anticipated date for Agency responses to written questions is June 27, 2023.
  • Deadline for receipt of responses to the ITN is 12:00 p.m. August 15, 2023.

While review of the ITN is still ongoing, there are some key details to the proposed contracts that AHCA intends to award that stand out. The first is that AHCA intends to award contracts to “nationally accredited plans that offer an enhanced delivery systems and integration of behavioral and physical health services.” This focus on behavioral health services will provide significant benefits to enrollees and will provide a competitive advantage to prospective bidders who already have integrated behavioral health programs.

Additionally, AHCA has introduced what it calls “plus plans.” These plans are designed to allow family members to receive their services from a Medicaid managed care single plan that provides Managed Medical Assistance (“MMA”), Long Term Care (“LTC”), and specialty plans. According to the ITN, “[e]nrollees will no longer need to change plans to access specialty population services, split families up among multiple plans or choose between accessing Specialty plans.”

The ITN requires that providers that wish to provide LTC services must submit proposals that have them acting either as a comprehensive long term care plan, a comprehensive long term care-plus plan, or a selected comprehensive plan. MMA providers will be required to act either as a comprehensive LTC plan, a comprehensive LTC-plus plan, a MMA plan, or a MMA-plus plan. Finally, providers bidding on specialty services will be required to serve as a comprehensive LTC-plus plan or a MMA-plus plan.

Finally, due to legislative changes, AHCA will be able to award these contracts on either a statewide or regional basis. It should also be noted that this same legislative change also reduced the number of Medicaid regions from 11 to 9.

This is the third time that AHCA has bid these contracts. The prior two bids led to significant bid protests over who should be awarded these contracts. For more information on protesting an ITN award, please see our article Bid Protest – Know your Rights, the Clock is Ticking. With tens of billions of dollars at stake, it is likely that this will happen again. Should you decide to submit a bid, you should prepare your response with a protest in mind – making sure that all the ITN requirements are met and arranged in proper form. If you need assistance preparing your ITN response or have questions about the ITN, please feel free to contact us to discuss your options.

SMMC Contracts are on the Horizon: The ITN Has Now Been Released by AHCA

AHCA has now released the Invitation to Negotiate (“ITN”) for the new Statewide Medicaid Managed Care contracts. The details as well as the actual ITN can be found here: https://ahca.myflorida.com/medicaid/statewide-medicaid-managed-care/2023-smmc-re-procurement

Importantly, AHCA has set the following key deadlines:

  • Deadline for receipt of written questions is May 3, 2023.
  • The anticipated date for Agency responses to written questions is June 27, 2023.
  • Deadline for receipt of responses to the ITN is 12:00 p.m. on August 15, 2023.

Given what is at stake, bid protests over the award (and the specifications) are almost a given. While our article on bid protests covers this issue in more detail and can be found here, there are a few key things you should know about bid protests if you are considering bidding on the SMMC contracts.

The first issue is specification challenges. Specification challenges are challenges to the terms, conditions, or specifications contained in the solicitation (including any provisions governing the methods for ranking bids, awarding contracts, reserving rights for further negotiation, or modifying or amending any contract). If a potential bidder wished to make a specification challenge, a notice of protest must be filed within 72 hours after posting of the solicitation. Failure to timely file this notice of protest will result in waiving any challenges that the specifications were biased, unclear, or otherwise deficient. As the ITN was published on April 11, 2023 at 02:10 p.m., that means that any protest seeking to challenge these specifications must be made by Thursday, April 14, 2023 by 2:10 p.m.

The second issue arises after the intended award is posted. Any eligible person who wishes to challenge the award (or intended award) must file a notice of protest within 72 hours of the posting. These timelines, like the other timelines discussed in the linked article, are strict deadlines and failure to meet them will likely result in a waiver of your right to protest.

With billions of dollars at stake on these SMMC contracts, you should be preparing your response to the ITN with a bid protest in mind – both to defend your award if you win and to place yourself in a good position to challenge if you are unsuccessful.

If you need assistance preparing your ITN response or if you are considering a bid protest to either the specifications or award of the new SMMC contracts, the experienced legal counsel at Smith & Associates can help. Contact us for a free consultation to discuss your rights.

Operation Nightingale – Know Your Rights

The U.S. Department of Justice is pursuing criminal charges against six Florida schools accused of engaging in a scheme to sell fraudulent nursing degrees, diplomas, and transcripts following an investigation by the FBI. These six schools and the relevant time frames for when they are accused of selling the fraudulent degrees are as follows:

  • Siena College/Siena College of Health, Lauderhill (10/2003 to 9/2022)
  • Sacred Heart International Institute, Fort Lauderdale (8/2017 to 9/2021)
  • Quisqueya School of Nursing LLC (“Sunshine Academy”), Boynton Beach (10/2016 to 12/2020)
  • Med-Life Institute WPB,LLC, West Palm Beach (10/2016 to 12/2020)
  • Quisqueya Health Care Academy, LLC, Lake Worth (10/2016 to 12/2020)
  • Palm Beach School of Nursing, LLC, West Palm Beach (10/2016 to 12/2020)

It is alleged that this scheme by these schools resulted in the issuance of 7,600 fraudulent nursing degrees.

In response, the State of Florida, Department of Health has begun issuing investigation letters to nurses that it believes obtained these fraudulent degrees. These letters do not provide any of the alleged information that DOH is relying on to claim that the degree is fraudulent. Further, these letters provide the recipient with an opportunity to respond to the investigation, and also provides the recipient with a form to voluntarily relinquish their nursing license.

If you are a nurse and you received one of these letters, you should contact an attorney to discuss your rights. For example, New York, which is also dealing with this issue, admits that not all of the nursing degrees issued by these schools during this time frame were fraudulent and is giving nurses the opportunity to prove their degrees were “real.” In Florida, however, the burden is on DOH to prove, by clear and convincing evidence, that the nurse violated a specific statute or rule and that, due to that violation, the nursing license should be revoked. Some of the specific statutes cited by the DOH investigation letter are:

  • Attempting to obtain, obtaining, or renewing a license to practice a profession by bribery, by fraudulent misrepresentation, or through an error of the department or the board. Fla. Stat. s. 456.072(1)(h);
  • Making deceptive, untrue, or fraudulent representations in or related to the practice of a profession or employing a trick or scheme in or related to the practice of a profession. Fla. Stat. s. 456.072(1)(m);
  • Failing to comply with the requirements for profiling and credentialing, including, but not limited to, failing to provide initial information, failing to timely provide updated information, or making misleading, untrue, deceptive, or fraudulent representations on a profile, credentialing, or initial or renewal licensure application. Fla. Stat. s. 456.072(1)(w); and
  • Procuring, attempting to procure, or renewing a license to practice nursing or the authority to practice practical or professional nursing pursuant to s. 464.0095 by bribery, by knowing misrepresentations, or through an error of the department or the board. Fla. Stat. s. 464.018(1)(a).

Before DOH can revoke any nursing license pursuant to these statutes, it has the burden to show that each element of the above cited statutes has been met. While it is currently unknown to the public what specific information DOH has from the FBI about any individual nurse or degree, absent clear and convincing evidence that a specific nurse’s degree was obtained fraudulently, it will be difficult to meet this burden.

Importantly, it appears that there are students that attended these accredited nursing schools that actually completed the required course work and clinical hours. While it is DOH’s burden to prove otherwise, with the appropriate documentation, affected nurses may be able to reach a quick resolution with DOH and avoid any adverse actions against their licenses.

If you have received an investigation letter from DOH regarding these nursing schools and allegations of fraudulent degrees, you should contact an attorney to help you understand your rights. At Smith & Associates we have decades of experience dealing with health care licensing issues and are here to assist you should you become the subject of a DOH investigation. Please contact us for a free initial consultation.