The Issue The issues to be resolved in this proceeding concern whether the Respondent violated the statutes and regulations cited in the Second Amended Administrative Complaint and referenced in this Recommended Order at the time of a survey for compliance conducted on October 1 and 2, 2002. If any of the charged violations occurred, it must be determined whether an administrative fine should be imposed, and, if so, in what amount. It must also be determined whether Heron Pointe should be subjected to the imposition of a conditional licensure status as a result of any proven violations.
Findings Of Fact The Petitioner is an Agency of the State of Florida charged with regulating and licensing nursing homes in Florida, and conducting surveys and evaluations of nursing homes in accordance with the provisions of Chapter 400, Florida Statutes, and specifically Section 400.23(7), Florida Statutes. The Respondent, Heron Pointe, is a licensed nursing home located in Brooksville, Florida. The death of a resident occurred on October 1, 2002, in Heron Pointe's facility. In accordance with law the facility immediately reported the death to the Respondent Agency (AHCA). The resident is hereinafter referred to as "Resident One." Because of the reported death of Resident One, AHCA conducted a compliance survey of Heron Pointe on October 1-2, 2002. As a result of that survey, AHCA found four deficiencies, called in the parlance of nursing home regulations "tags." The tags were cited in AHCA survey report resulting from the October 1-2 survey and represent four different regulatory provisions. They are referred to hereinafter as Tags F221, F224, F281, and F490. Those tags or deficiency reports correspond to Counts I, II, III, and IV of the Second Amended Administrative Complaint. Resident One was admitted to Heron Pointe from another nursing home facility because her family was not pleased with the care received at the other facility. She was admitted in March 2003, with pressure sores, including one on her coccyx. She had a Foley catheter at that time, as well as a feeding tube. Resident One suffered from dementia and a number of other medical conditions and was placed in Hospice care on or about August 26, 2002. This was because of a terminal diagnosis by her physician. Resident One was in a severely debilitated condition, which made it quite difficult to treat and heal the pressure sores which she had when she came to the facility. The nursing and medical staff aggressively treated the pressure sores and through effective nursing care were able to heal the pressure sore on the resident's coccyx. Resident One also developed a small wound on her left hip while she was at Heron Pointe. Her condition continued to decline and she developed anxiety, restlessness, and self- abusive behavior as an adjunct of her debilitated mental condition. This caused her to frequently scratch at her skin, constantly remove wound dressings, and to dig at her hip wound. Resident One thus created a severe wound described as a "deep and painful tunneling hole" on her left hip. This behavior and the nursing staff's treatment of it in attempts to alleviate it are well documented in nursing notes. In fact the nursing staff testified that such severe self-abusive behavior had never been encountered in one of their residents. They aggressively applied various nursing modalities to treat it and attempt to deal with it while keeping the resident comfortable. A number of nursing and medical interventions were used to address the self-abusive behavior. Various medications were ordered by her treating physician to calm her and to alleviate any itching and pain that she might be experiencing at the hip wound site, which might be prompting her, in part, to dig at the wound with her finger and finger nails. A number of types of bandages were tried in an effort to find one which she would not readily remove. The staff positioned her in bed with her hands above the covers to dissuade her from digging at her hip and she was given stuffed animals as a distraction to attempt to keep her from wanting to dig at her hip wound. This is a professionally appropriate nursing practice in treating and dealing with residents with dementia. She was also placed in a room near the nurse's station where staff could more frequently and readily monitor her and observe her behavior and condition. The above-described nursing approaches had some sporadic success, but her self-abusive behavior continued. The Hospice staff, which also was involved in the resident's care, suggested that the facility use latex gloves on the resident, which was an intervention the staff used with some success to address the resident's tendency to dig at the wound. While the gloves did not actually physically prevent the resident from digging at the wound, they served as a distraction. The resident enjoyed wearing the gloves and would proudly show them to facility nurses and to some extent they seemed to distract her from her desire to dig at the hip wound. Although they did not stop the behavior entirely, they did lessen its destructive effect somewhat. They did not limit the resident in normal access to her body and other movements anymore than would bandages. Digging at a wound, in any event, does not constitute "normal access" to one's body. This intervention, however, like others used, had only limited success because the resident soon began taking off the gloves, which she was freely able to do. In the early morning hours of October 1, 2002, the resident was noted to be increasingly anxious and fidgety, to the extent of pulling out her Foley catheter and pulling on her feeding tube. In an effort to distract the resident, a certified nursing assistant tried using the latex gloves on her hands, sometime before 4:00 a.m. The assistant notified the floor nurse that the resident had pulled out her Foley catheter, whereupon the nurse went into the resident's room to give medication prior to replacing the catheter. The nurse observed at that time that the resident was displaying the gloves to her as she often did and pulling them further on to her hands. The nurse again observed the resident at 6:00 a.m. that morning at which point she was no longer wearing the gloves but was lying peacefully in bed and no longer fidgeting. A certified nursing assistant observed the resident at about 9:00 a.m. on October 1, 2002, and found her unresponsive in her bed. The nurse was called to the room, examined the resident, and confirmed that the resident had expired, apparently by asphyxiation. At that time a latex glove was found in the resident's mouth. Count I (Tag F221) The Second Amended Administrative Complaint charges that the facility was not in compliance with Section 400.022(1)(o), Florida Statutes, and 42 C.F.R. Section 483.13(a). This statute and the related federal rule in essence mandate that a facility and its staff may not use physical or chemical restraints except those authorized in writing by a physician for a specified emergency purpose and for a limited period of time. They may not be used in lieu of staff supervision or merely for convenience, punishment, or reasons other than the protection or safety of residents. AHCA contends that the facility failed to ensure that Resident One was free of any restraint for which a medical symptom was not indicated. It has not been established that the latex gloves used on Resident One were indeed a restraint. The term is not defined in the federal regulation nor in the state statute. However, the State Operation Manual used by surveyors as guidance in applying the statute and the federal regulation, defines physical restraints as any physical or mechanical device, material, or equipment attached or adjacent to a resident's body that the individual resident cannot remove easily and which restricts freedom of movement or normal access to the resident's body. It is undisputed that this definition applies to the instant situation. It is undisputed as well that Resident One could remove the gloves and indeed the un-refuted evidence showed that she could remove them easily. The resident removed the gloves frequently and could not have been able to remove them so frequently had they not been easily removable. There was no evidence that she had any difficulty in removing the gloves. Additionally, AHCA acknowledged that the gloves neither restricted the resident's freedom of movement nor prevented her from doing anything. The gloves may have resulted in diminished tactile sensation in the hands and fingers of the resident but, inasmuch as these types of gloves are used routinely for medical and nursing procedures, such reduction is minimal. Neither the testimony of nursing personnel nor any other evidence, such as medical or nursing literature or regulatory guidelines, suggests that latex gloves should be considered as restraints. There is no evidence to suggest that any nursing home industry practice or standard would establish that latex gloves constitute a restraint. Heron Pointe's witness, Ms. Brock, who is accepted as an expert witness in long-term care nursing, established that latex gloves have been used on occasion for such purposes as keeping a bandage on a resident's hand and are not considered a restraint under those circumstances, nor do they require a physician's order. Gloves are readily accessible throughout all nursing homes and are typically kept in a wall dispenser in each resident's room, for use by staff and families and accessible to mobile residents. No effort is made to keep them away from residents, even those with cognitive impairment, and such procedures involving the placement and handling of latex gloves are not the subject of charged deficiencies in AHCA regulation and inspection of nursing homes. AHCA contends that the gloves are inherently dangerous to residents with cognitive disabilities. This position, however, is refuted by the evidence establishing that it is a routine industry practice that residents and their families have ready access to the gloves, and the practice indeed continues at Heron Pointe, as well as elsewhere. AHCA has required no changes in accessibility to latex gloves as a result of its surveys of Heron Pointe. The opinion of AHCA's expert in nursing home administration to the effect that the gloves are inherently harmful to a resident is not deemed credible. AHCA has not established that the gloves were imposed for purposes of discipline or convenience, even if they could be deemed a restraint, which they are not, and has not established that the gloves were not required to treat the resident's medical symptoms. No evidence has been adduced to show that the gloves were applied to Resident One for purposes of disciplining her or as a convenience to the facility staff. Indeed, it was undisputed that the gloves were applied to address a difficult medical situation, the resident's self-destructive behavior causing her to mutilate her hip wound. Count II: Tag F224 As to this charged deficiency, AHCA asserts that the facility was not in compliance with 42 C.F.R. Section 483.13(c)(1)(i), which mandates facilities to develop and implement written policies and procedures to prevent abuse and neglect or mistreatment of residents. The Agency contends that Heron Pointe failed to prevent neglect by not accessing, monitoring, and imposing a care plan for the device applied to the resident's hand, the latex gloves. No concrete, persuasive evidence was presented to establish that the facility violated the regulatory requirement related to the charge in this count to develop and implement policies. The state surveyor responsible for making the initial findings and report underlying this "tag" acknowledged that she had reviewed no policy or procedure of the facility and had not asked to see or review any policies of the facility. The un- refuted evidence indeed establishes that the facility has a written policy, and had implemented it, designed it to prohibit mistreatment, neglect, or abuse of residents. Un-refuted evidence also establishes that anti-neglect policies and procedures for nursing homes in Florida are designed to and required to address only the investigation of incidents involving residents and to establish procedures or protocols for notification of appropriate agencies. Such policies and procedures are not designed to nor required to address particular residents' care, incidents, or issues. In the instant situation the evidence establishes that Heron Pointe followed its written and approved policy and procedure by making telephone notification to the various agencies it was required to notify when the incident involving the resident's death occurred, including notification of AHCA and conduct of its own internal investigation. Un-refuted evidence establishes that Heron Pointe followed all the required policies and procedures with regard to Resident One when the incident in question occurred. Under the charge in this count AHCA espouses the premise that there was an act of neglect of Resident One and that one action of neglect will constitute a failure to implement the anti-neglect policy. It charges that the resident was neglected because the use of the gloves was not assessed, monitored, and "care-planned." The assertion that the facility failed to assess, monitor, and care-plan the gloves, and that such was required, is based on the false premise that the gloves were restraints. As found above, the gloves indeed did not constitute restraints for Resident One and thus the use of them in this way will not bring them into the requirement or protocol postulated by AHCA. In fact, to the extent that AHCA suggests that every nursing intervention must be formally assessed be part of a care plan and that the failure to do so will constitute neglect, there was no evidence that such protocol is industry practice, required by regulations, nor accepted standards of reasonable, professional nursing practice. Indeed, nurses daily employ interventions for residents both to improve their comfort, as well as to alleviate aberrant behaviors. Such interventions include positioning residents with pillows, the use of distractive measures such as, for instance, stuffed animals with dementia patients, the use of compresses to reduce fevers, and many other routine nursing measures designed to improve resident comfort and medical conditions. Such nursing interventions do not require a care plan, physician authorization, or formally-documented assessment, as established by the expert nursing testimony in this case. The use of the gloves in this instance falls within the realm of such normal, acceptable professional nursing practice. AHCA also assents that Heron Pointe neglected Resident One by failing to take further measures to determine a physical cause for her scratching and itching. Its witness avers that there was inadequate contact with the resident's physician. Aside from the fact that these allegations were not clearly pled in the Second Amended Complaint and, therefore, should not be considered, the evidence establishes that these contentions are not accurate. Indeed, Resident One was seen numerous times by the physician or the physician's assistant assigned to her, and numerous changes were made for dressings and medications in an effort by the physician and the staff to relieve the resident's anxiety, itching, and pain. Although AHCA witnesses suggested that the physician had not been made sufficiently aware of the resident's problems and her behavior, that testimony is not persuasive. The resident's records clearly contradict that position. In the month of September alone, for instance, Resident One was seen four times by the physician or the physician's assistant, and the resident's primary nurse testified and documented that she was in nearly daily contact with the resident's physician concerning the resident's condition and progress. There was simply no evidence that Resident One was neglected. The nurses checked Resident One far more often than most residents because of her behaviors and medical condition and their attempts to heal her pressure sores and keep dressings on her wounds. She was turned at least every two hours and sometimes hourly. Resident One's nurse's testimony shows that the staff were exceedingly attentive to the needs of the resident and did everything that they could think of within the realm of nursing practice to alleviate the resident's discomfort and medical condition. Use of the gloves was one of many interventions used to address the unusual situation of the resident's self-destructive behavior, behavior which the staff had clearly made the resident's physician aware of on a frequent basis. It was not evidence of neglect, but rather of concern for the resident's well-being. Indeed, if there had been an official assessment of the gloves and if they had been formally written into a care plan, there would have still been no reason to foresee the possibility that the resident would put a glove in her mouth. None of her care-givers considered this as a possibility since the resident had not displayed any behavior to suggest such a possibility. The resident could have just as easily removed a bandage or picked up another relatively small, necessary item in her care environment, placed it in her mouth, and asphyxiated herself. She had displayed no behavior to put the staff on notice that this was a foreseeable possibility. Care of residents with dementia requires creativity by the nursing staff. No two residents exhibit the same set of behaviors. It is not a typical behavior for Alzheimer's residents to put things in their mouths. If a resident with dementia develops aberrant behaviors, they typically become repetitive, such as Resident One's self-mutilation. If Resident One were prone to putting items in her mouth, there were other items readily available to her to put in her mouth, and yet she had exhibited no such behavior before the day of her death. Without exhibiting such behaviors, there was no reason for the staff to have foreseen that she would put a latex glove in her mouth. Count III: Tag 281 AHCA contends that the facility has violated 42 C.F.R. Section 483.20(k)(3)(i), which requires that services provided by the facility must meet professional standards of quality. Specifically AHCA maintains that the facility failed to ensure that the staff provided care in accordance with acceptable professional standards of practice for use of latex gloves for the prevention of the scratching, digging behavior, and failed to ensure the obtaining of physician's orders for medical or other types of restraints, with regard to the latex gloves. The assertion of this deficiency was also based on the false premise that the gloves constituted a restraint. AHCA witnesses opined in conclusory fashion, without a factual basis or support in any literature, that the use of gloves on a resident is a restraint and is inappropriate. The above-found facts established that the gloves were not used for convenience or punishment, were easily removable, and did not restrict access to the resident's body. Because these facts with regard to the use of the gloves were not proven, it was not established that they were restraints which require obtaining a physician's order. That not being established, it was not established that any accepted professional standards of quality of practice by nurses or staff members, for use of latex gloves, was violated. Heron Pointe's expert nursing witness established other uses of latex gloves on residents by nurses, without a physician's order, which are within acceptable standards of nursing practice, as found concerning the previous count. Ms. Brock opined and established that the gloves were a unique and innovative nursing measure under the circumstances presented by this resident, and were appropriate in terms of professional nursing and resident care practices for addressing the self- destructive behavior exhibited by Resident One. Ms. Brock's testimony was persuasive and credible and is accepted in this regard. Count IV: Tag F490 AHCA alleges that Heron Pointe violated 42 C.F.R. Section 483.75, because the facility was not administered in manner enabling it to use its resources effectively and efficiently to maintain or attain the highest practicable physical, mental, and psycho-social well-being of each resident. The Agency relied on the factual allegations from previous counts of the Second Amended Administrative Complaint under the theory that the administrator is ultimately responsible for the operations and management of the facility and the carrying-out of approved facility policies. The evidence does not establish that the administrator or management of the facility failed to take action or neglected its duties concerning the allegations, in the counts of the Second Amended Administrative Compliant, however. The administrator promptly notified all appropriate agencies regarding the incident and death of Resident One in the manner provided for by the facility's policies and the regulations and statutes that apply to the facility. Indeed the Agency acknowledged that it would be impossible for an administrator to know all specifics concerning each resident, but the Agency took the position that regardless of that impossibility that the administrator was charged with knowledge that the latex gloves were used on Resident One and that he should have made sure that they were not used. The evidence, however, demonstrated that the administrator of Heron Pointe was generally and sufficiently aware of Resident One's condition and circumstances, in accordance with relevant regulatory requirements, and followed facility policies with regard to adequate staffing and adequate staff oversight and practice concerning the resident's care. There was no evidence presented which would establish that any other resident had used or had been made to use latex gloves, or that any other resident had been the subject of the use of any inappropriate restraints, or that any other resident was at risk in any other way. This demonstrates that the incident with Resident One, however regrettable, was an isolated incident and does not constitute preponderant evidence that the facility and its administrator and administration failed to use the facility's resources effectively and efficiently to attain or maintain the highest practicable physical, mental, and psycho-social well-being of each resident. Unfortunately, the provision of appropriate or "highest practicable" levels of care to all residents of a facility and to individual residents, as to that resident's specific problems, needs, and conditions, cannot always prevent a tragedy.
Recommendation Having considered the foregoing Findings of Fact, Conclusions of Law, the evidence of record, the candor and demeanor of the witnesses, and the pleadings and arguments of the parties, it is, therefore, RECOMMENDED that a Final Order be entered by the Agency for Health Care Administration dismissing the Second Administrative Complaint in its entirety; issuing a standard rating to the Heron Pointe facility; and finding that no deficiencies described under the tags and regulations cited and discussed above have occurred, correcting all relevant records concerning licensure or regulation of the Respondent's facility to reflect the absence of any deficiencies at Heron Pointe stemming from the survey of October 1-2, 2002. DONE AND ENTERED this 12th day of May, 2004, in Tallahassee, Leon County, Florida. S P. MICHAEL RUFF Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 SUNCOM 278-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with Clerk of the Division of Administrative Hearings this 12th day of May, 2004. COPIES FURNISHED: Michael O. Mathis, Esquire Agency for Health Care Administration Fort Knox Building III, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308 Gerald L. Pickett, Esquire Agency for Health Care Administration Sebring Building, Suite 330K 525 Mirror Lake Drive, North St. Petersburg, Florida 33701 Donna Holshouser Stinson, Esquire Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302-1300 R. Davis Thomas, Jr., Esquire Broad and Cassel 215 South Monroe Street, Suite 400 Post Office Drawer 11300 Tallahassee, Florida 32302-1300 Lealand McCharen, Agency Clerk Agency for Health Care Administration 2727 Mahan Drive, Mail Station 3 Tallahassee, Florida 32308 Valda Clark Christian, General Counsel Agency for Health Care Administration Fort Knox Building, Suite 3431 2727 Mahan Drive Tallahassee, Florida 32308
The Issue Respondent's alleged violation of subsections 460.13(3)(f) and (g)(1), Florida Statutes. At the commencement of the hearing, petitioner withdrew Count I of the complaint that alleged a violation of Rule 21D-2.01, F.A.C. and subsection 460.13(3)(g)(1), Florida Statutes.
Findings Of Fact Respondent was a licensed chiropractor in the state of Florida on December 26, 1976, and is so licensed at the present time. His office is located in North Miami Beach, Florida. (Stipulation, Exhibit 2) Respondent received his professional education at the Palmer College of Chiropractic in Davenport, Iowa. After graduation, he interned for a period of approximately six months until October, 1976. While at the Palmer College, he studied the Grostek method of diagnosis and treatment that is part of the school curriculum. This method teaches that all of the nerves connected to the spinal cord are affected by bone misalignment in the upper cervical area. This can have adverse affects upon the spine and a person's general health. Diagnosis of this condition is made by the use of x-rays. Once a bone misalignment is determined to exist, the chiropractor uses light pressure or force adjustment to reposition the bone. Finally, x-rays are again taken to see if the desired change has been effected by the treatment. This method is restricted to the cervical area below the base of the skull. Respondent also is a member of the National Upper Cervical Chiropractic Association (NUCCA) that espouses a more refined Grostek method involving only a different stance of the chiropractor in making the bone adjustment. That organization conducts continuing education courses, performs research and issues regular monthly bulletins. Although there are several hundred chiropractors in the United States who practice the NUCCA method, at present there are only three in Florida. The Grostek method originated approximately twenty-five years ago. Although the Grostek technique is not used extensively in Florida, it is an accepted method of diagnosis and treatment in the profession. The primary difference in the Grostek and NUCCA techniques and that used by other chiropractors is the manner in which x-rays are utilized. Respondent specializes in the NUCCA method and if he does not discover a bone misalignment in the cervical area, he refers the patient to another chiropractor. (Testimony of Respondent, Dr. Carroll, Exhibits 2, 3) While at Palmer College, respondent also received lectures on the subject of iridology. This topic deals with the matter of toxic areas in the body and involves the examination of the iris of the eye to determine what area of the body is affected. The chiropractor may recommend a change in diet as a means of removing a particular problem. Iridology is an accepted adjunct to chiropractic treatment and is employed by respondent in his practice on occasion. However, it is entirely separate and apart from the NUCCA method. (Testimony of respondent) A reporter for the North Dade-South Howard Journal asked the respondent for an interview to explain the NUCCA method. He had been referred to respondent by one of the latter's patients. Respondent granted the interview and the subsequent conversation included matters concerning both NUCCA and iridology. The article was not submitted to respondent for approval prior to publication, and was published in the newspaper on December 26, 1976. It contained misquotes, inaccurate summations of the interview and implied that iridology was a part of the NUCCA method. Although the article referred to a claim of respondent that by detecting toxicity in the body with a small flashlight and a magnifying glass, the need for exploratory surgery in patients could largely be eliminated, respondent denied making such a statement. A witness testified at the hearing that the same reporter grossly misquoted her in an article concerning the benefits of a vegetarian diet. (Testimony of respondent, Galton, Exhibit 1)
Recommendation That the Administrative Complaint against respondent be dismissed. Done and Entered this day of August, 1977, in Tallahassee, Florida. THOMAS C. OLDHAM Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 COPIES FURNISHED: Ronald LaFace, Esquire Post Office Box 1572 Tallahassee, Florida 32304 Herbert L. Fehner, Esquire 300 Marine Plaza on the Intracoastal 3100 E. Oakland Park Boulevard Ft. Lauderdale, Florida 33308
The Issue At issue in this proceeding is whether proposed Florida Administrative Code Rule 64B17-6.008 (the “Proposed Rule) constitutes an invalid exercise of delegated legislative authority.
Findings Of Fact Parties FSOMA is a member association established to protect and promote the practice and profession of acupuncture. Approximately 350 of FSOMA’s 650 members are licensed acupuncturists practicing in Florida, as regulated by chapter 457, Florida Statutes. Three of those acupuncturist members are also licensed physical therapists (“PTs”) in Florida. Most of the other FSOMA members are students seeking master’s degrees in acupuncture. The Board was legislatively created within the Department of Health to oversee the regulation of the practice of physical therapy in the State of Florida. § 486.023(1), Fla. Stat. Five of the seven Board members must be Florida-licensed PTs who have been engaged in the practice of physical therapy for at least four years immediately prior to their appointment. § 486.023(2), Fla. Stat. The Board’s powers and duties include the ability to “establish or modify minimum standards of practice, and adopt rules pursuant to sections 120.536(1) and 120.54 to implement the provisions of [chapter 486].” § 486.025, Fla. Stat. FPTA is a not-for-profit professional association organized in compliance with section 501(c)(6) of the Internal Revenue Code. It is a voluntary membership organization that is a component chapter of a national organization, the American Physical Therapy Association (“APTA”). As of May 2018, FPTA’s membership included 3,319 licensed PTs, 698 Florida-licensed physical therapist assistants, 1,851 students pursuing Doctor of Physical Therapy degrees, and 539 students pursuing physical therapist assistant degrees. Applicable statutes Section 457.102(1) defines “acupuncture” as follows: “Acupuncture” means a form of primary health care, based on traditional Chinese medical concepts and modern oriental medical techniques, that employs acupuncture diagnosis and treatment, as well as adjunctive therapies and diagnostic techniques, for the promotion, maintenance, and restoration of health and the prevention of disease. Acupuncture shall include, but not be limited to, the insertion of acupuncture needles and the application of moxibustion to specific areas of the human body and the use of electroacupuncture, Qi Gong, oriental massage, herbal therapy, dietary guidelines, and other adjunctive therapies, as defined by board rule. (emphasis added). Section 486.021(11), Florida Statutes, defines the “practice of physical therapy” as follows, in relevant part: (11) “Practice of physical therapy” means the performance of physical therapy assessments and the treatment of any disability, injury, disease, or other health condition of human beings, or the prevention of such disability, injury, disease, or other condition of health, and rehabilitation as related thereto by the use of the physical, chemical, and other properties of air; electricity; exercise; massage; the performance of acupuncture only upon compliance with the criteria set forth by the Board of Medicine, when no penetration of the skin occurs; the use of radiant energy, including ultraviolet, visible, and infrared rays; ultrasound; water; the use of apparatus and equipment in the application of the foregoing or related thereto; the performance of tests of neuromuscular functions as an aid to the diagnosis or treatment of any human condition; or the performance of electromyography as an aid to the diagnosis of any human condition only upon compliance with the criteria set forth by the Board of Medicine . . . . (emphasis added). Proposed Rule The full text of the Proposed Rule is as follows: 64B17-6.008 Minimum Standards of Practice for Dry Needling in the Practice of Physical Therapy For the purpose of this rule, “dry needling” is a skilled technique based on western medical concepts performed by a physical therapist using apparatus or equipment of filiform needles to penetrate the skin and/or underlying tissues to affect change in body structures and functions for the evaluation and management of neuromusculoskeletal conditions, pain, movement impairments, and disability. The minimum standards of practice for dry needling in the practice of physical therapy shall include competence demonstrated by successful completion of education that includes the subject areas listed in the following paragraphs, and that is accredited, sponsored, or approved by the Commission on Accreditation in Physical Therapy Education, the American Physical Therapy Association, the Florida Physical Therapy Association, the Federation of State Boards of Physical Therapy, or any branch of the United States Armed Forces: Evidence-based instruction on the theory of dry needling practice; Selection and safe handling of needles and other apparatus and equipment, including hygiene and infection control pursuant to relevant standards of the United States Centers for Disease Control and Prevention or the United States Occupational Safety and Health Administration; Dry needling indications and contraindications; Anatomical review for safety and effectiveness as it applies to dry needling; Psychomotor skills needed to physically perform dry needling; and Postintervention care, including an adverse response or emergency. The education shall include a face-to- face component with interaction with the course instructor and an in-person examination of cognitive and psychomotor skills related to dry needling. A physical therapist who performs or offers to perform dry needling shall supply the Department, upon request, with written documentation of his or her competence to perform dry needling. A physical therapist shall not delegate the practice of dry needling to a physical therapist assistant, unlicensed personnel, or any other person who is not a physical therapist. Rulemaking Authority 486.025 FS. Law Implemented 486.021(11) FS. History--New . Amended Petition In its Amended Petition, FSOMA asserts that the Proposed Rule constitutes an invalid exercise of delegated legislative authority because dry needling is outside the scope of physical therapy practice under section 486.021(11). In purporting to establish standards of practice for dry needling, the Board is presuming, without statutory authority, that dry needling is within the scope of practice of physical therapy. FSOMA states that dry needling is simply acupuncture by another name and that the statutory definition of “practice of physical therapy” expressly prohibits PTs from employing acupuncture techniques that penetrate the skin. FSOMA notes that section 457.102(1) provides that “[a]cupuncture shall include, but not be limited to, the insertion of acupuncture needles and the application of moxibustion to specific areas of the human body . . . .” In the practice of dry needling, PTs insert acupuncture needles into the human body. Therefore, dry needling meets the statutory definition of acupuncture and violates the physical therapy practice act, which allows PTs to perform acupuncture only “when no penetration of the skin occurs.” FSOMA further asserts that dry needling does not fall under any of the permitted modalities listed in section 486.021(11), i.e., “the use of physical, chemical, and other properties of air; electricity; exercise; massage; the performance of acupuncture only upon compliance with the criteria set forth by the Board of Medicine, when no penetration of the skin occurs; the use of radiant energy, including ultraviolet, visible, and infrared rays; ultrasound; [or] water ” FSOMA also contends that the Proposed Rule does not adequately train physical therapists in the insertion of filiform needles into the human body, which poses an increase in the potential for harm to patients as well as to the profession of acupuncture. FSOMA is concerned that patients will confuse dry needling with acupuncture, and that the harm to patients caused by ill-trained PTs performing dry needling will be associated in the public mind with the practice of acupuncture. Finally, FSOMA argues that dry needling by PTs constitutes cultural misappropriation of traditional Chinese medicine. PTs claim that dry needling is founded entirely on concepts of western medicine, which has a marginalizing effect on the profession of acupuncture. FSOMA made this claim as a ground for standing to bring this rule challenge. The Board and FPTA have challenged FSOMA’s standing to bring this proceeding, on the ground that acupuncturists have no recognized interest in the adoption of rules by a competing profession. FSOMA’s standing is dependent on the claim that dry needling constitutes the practice of acupuncture and is therefore an illicit encroachment on the profession practiced by the 350 FSOMA members who are licensed acupuncturists. If dry needling by PTs is not the practice of acupuncture, then the Board’s objection to FSOMA’s standing is well taken. Dry needling Dry needling was initially developed in the 1940s by Janet Travell, M.D., in collaboration with David Simons, M.D., through studies of injection therapy during which empty, i.e. “dry,” hypodermic needles were thought to be effective in treating “myofascial trigger points,” which are contractures in muscles usually caused by overuse or trauma.2/ Over time, the hypodermic needle used by Dr. Travell has given way to the solid filiform needle as the instrument of choice among PTs who perform dry needling. The Proposed Rule specifically states that dry needling is done with “filiform needles.” The Food and Drug Administration (“FDA”) classifies the needle used in dry needling as an “acupuncture needle,” defined as “a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.” 21 C.F.R. § 880.5580(a). It is a prescription device and must be labeled for single use only. 21 C.F.R. § 880.5580(b).3/ FSOMA points to the 1996 FDA order adopting 21 C.F.R. § 880.5580, in which the FDA stated that the sale of these needles “must be clearly restricted to qualified practitioners of acupuncture as determined by the States.” 61 Fed. Reg. 64616 (Dec. 6, 1996) [FR Doc No: 96-31047]. FSOMA contends that the quoted language clearly restricts the use of acupuncture needles to licensed practitioners of acupuncture and that the use of these devices by PTs in dry needling is the practice of acupuncture in violation of their own practice act. The Board and FPTA respond by emphasizing the “as determined by the States” language in the FDA’s order. They note that the FDA places the onus on manufacturers and distributers to properly label prescription devices with either “Rx only,” “R only,” or a caution statement identifying the practitioner(s) licensed by applicable state law to use the device. 21 C.F.R. § 801.109(a)-(b). Mark McElroy, a former major in the United States Air Force and an expert in orthopedic physical therapy, testified that he began using dry needling technique while serving as a PT in the Air Force. Mr. McElroy testified that when performing dry needling in the Air Force, he would use Red Coral Myotech Dry Needles because they are stiffer than acupuncture needles and easier to grip. At the hearing, Mr. McElroy read the label on these needles as stating, "Federal law restricts the device to the sale, buy [sic], or the order of qualified practitioners of physical therapy and acupuncture as determined by the states." The Board and FPTA further note that the FDA defines an acupuncture needle differently than does Florida's acupuncture rule. Under 21 C.F.R. § 880.5580(a), an acupuncture needle is a “solid, stainless steel needle” of indeterminate diameter. Florida Administrative Code Rule 64Bl-3.001(4) provides for use of a "filiform," i.e., threadlike, needle without designating any particular material. Both definitions call for use of "solid" needles, but contain no other overlapping criteria. The undersigned observes that the FDA’s use of the term “acupuncture needle” appears to be shorthand rather than prescriptive. The summary to the 1996 FDA order describes the devices as “acupuncture needles for the practice of acupuncture and substantially equivalent devices of this generic type,” which further supports the Board and FPTA’s view that the FDA’s regulation of acupuncture needles does not control the outcome of this proceeding. PTs indisputably perform dry needling with devices that the FDA has labeled “acupuncture needles”; however, this fact alone is not dispositive of the question whether PTs are performing “acupuncture” under Florida law when they dry needle. A February 2013 educational resource paper produced by APTA, Description of Dry Needling in Clinical Practice, provides the following useful description of the practice of dry needling: Dry needling is a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular and connective tissues for the management of neuromusculoskeletal pain and movement impairments. Dry needling [DN] is a technique used to treat dysfunctions in skeletal muscle, fascia, and connective tissue, and diminish persistent peripheral nociceptive input, and reduce or restore impairments of body structure and function leading to improved activity and participation. The physiological basis for DN depends upon the targeted tissue and treatment objectives. The treatment of myofascial trigger points (referred to as TrPs) has a different physiological basis than treatment of excessive muscle tension, scar tissue, fascia, and connective tissues. TrPs are hyperirritable spots within a taut band of contractured skeletal muscle fibers that produce local and/or referred pain when stimulated. TrPs are divided into active and latent TrPs dependent upon the degree of irritability. Active TrPs are spontaneously painful, while latent TrPs are only painful when stimulated, for example, with digital pressure. * * * DN can be divided into deep and superficial DN. Deep DN has been show to inactivate TrPs by eliciting local twitch response (LTR), which are modified by the central nervous system. Once the PT identifies a trigger point through palpation of the area, he inserts a needle deep into the tissue so that it touches the muscle and then stimulates the muscle using an up-and-down “pistoning” motion until a “twitch response” is elicited. Mr. McElroy described the process as follows: I would clean the area, clean my hands, put on gloves, take my dry needle, covering the area, making sure that I use all of the precautions that I’ve always been taught,[4/] insert the needle, look for that trigger point or that soft tissue that I’m trying to elicit the breakdown. I use a pistoning action, an up-and-down motion, looking for a twitch response. * * * Once I find the twitch response, the majority of the time I take the needle, I discard that needle. I then palpate along that same muscle area to see if I can find another--elicit another trigger response from the patient that is painful. Once again, I take another needle, I’ll insert that needle, I’ll piston up and down looking for another twitch response. I may do that anywhere from two to five times and then I’m done.[5/] Dr. Jan Dommerholt, an expert in physical therapy and dry needling, described the twitch response reaction as follows: A twitch response is an involuntary spinal cord reflex that actually--it’s just like a knee jerk if you go to the doctor and they tap the reflex hammer on your knee. If everything functions properly, you can’t really stop that, it happens no matter what. And that’s part of the test. That goes through your spinal cord. A twitch response is the same thing. It’s when a needle hits the right spot, there’s a signal to the spinal cord, and it brings it back and makes the muscle contract, that part of the muscle contract[s] very rapidly. So that’s a very objective sign that you’re in the right location. And you keep needling until the twitch responses subside. And usually immediately the patient has improved range of motion and their pain is significantly less. Dr. Dommerholt testified that in his practice, which is focused on chronic pain patients, dry needling allows the patient to “actually move again” and participate in exercises and other treatments. Dr. Dommerholt stated that dry needling is never used as an isolated procedure; it is always part of a larger physical therapy program. However, dry needling is generally the first treatment used because it offers the patient immediate relief from pain. The Board and FPTA presented an array of experts who testified as to the safety and efficacy of dry needling. Mr. McElroy, Dr. Edo Zylstra, Dr. Robert Sillevis, and Mr. Burton Reed are board-certified orthopedic clinical specialists, signifying their expertise in orthopedic physical therapy. In addition, Dr. Sillevis and Mr. Reed are fellows of the American Academy of Orthopedic Manual Physical Therapists, signifying their expertise in manual orthopedic physical therapy, which is a subspecialty within orthopedics. Dry needling is considered a subcomponent of the orthopedic manual physical therapy subspecialty. Mr. Reed testified that in his practice he found dry needling to be effective for treatment of athletes, who tend to have “overuse problems” because they are “hard on their bodies and encounter strains and sprains.” Both Mr. Reed and Dr. Zylstra testified about their experiences training National Football League (“NFL”) PTs and treating NFL players with dry needling. Mr. Reed has also used dry needling on major and minor league baseball players and professional soccer players. Mr. McElroy began using dry needling during his time at Andrews Air Force Base to treat individuals suffering from musculoskeletal or soft tissue sports injuries. During his deployment, he gained the majority of his dry needling experience treating Special Forces operators who sustained musculoskeletal injuries. Mr. McElroy explained that dry needling is generally effective for athletes who overexert themselves by going from “zero to hero” in their workouts, as well as for military personnel who require expedited recovery in order to deploy as scheduled. Training and safety FSOMA has alleged that the Proposed Rule does not adequately train PTs in the insertion of filiform needles into the human body and carries the potential for harm to patients and to the profession of acupuncture. Rather than establish specific course requirements and hours of study to be completed before a PT is allowed to dry needle, the Proposed Rule merely establishes what FSOMA witness David Bibbey termed an “expectation of competency” that is likely to be tested only after something has gone wrong and the Department of Health makes an inquiry. Under Florida law, an applicant for licensure as an acupuncturist must prove that he or she: Has completed 60 college credits from an accredited postsecondary institution as a prerequisite to enrollment in an authorized 3-year course of study in acupuncture and oriental medicine, and has completed a 3-year course of study in acupuncture and oriental medicine, and effective July 31, 2001, a 4-year course of study in acupuncture and oriental medicine, which meets standards established by the board by rule, which standards include, but are not limited to, successful completion of academic courses in western anatomy, western physiology, western pathology, western biomedical terminology, first aid, and cardiopulmonary resuscitation (CPR). § 457.105(2)(b), Fla. Stat. FSOMA emphasizes that Florida acupuncturists must be trained in western anatomy, physiology, pathology, and biomedical terminology, as well as the principles of Chinese medicine. David Bibbey is an expert in acupuncture who has studied some of the academic literature on dry needling. Mr. Bibbey runs a private acupuncture practice in Crystal River and has served as an adjunct professor at the Florida College of Integrative Medicine in Orlando. Mr. Bibbey’s office is an externship location for a training program in Gainesville. Mr. Bibbey has no experience in physical therapy or dry needling. Mr. Bibbey testified as to the amount of training that a candidate for licensure as an acupuncturist must complete before being allowed to perform the invasive technique of inserting acupuncture needles into a patient’s body. The Board of Acupuncture requires that a candidate complete a course with a minimum of 2,700 hours of supervised instruction. Of those 2,700 hours, 660 hours must be supervised clinical instruction, described by Mr. Bibbey as “either observing, doing case study, or under direct supervision of a licensed acupuncturist.” Mr. Bibbey described “case study” as “an opportunity to review on a case-by-case basis the circumstances that might bring [a patient] to the [acupuncturist’s] office in terms of a health condition and how that person might be assessed, what your treatment options are, communication, follow-up instruction, [and] clinical decision-making.” Mr. Bibbey testified that the typical clinical internship begins with observation during the first four semesters. After about 560 hours of observation in clinic, which include case study and supervised involvement in noninvasive procedures, and after demonstrating an understanding of proper needle insertion, the acupuncture student starts to employ the invasive procedure of inserting acupuncture needles through the skin and into the body, under supervision. This supervised performance of the invasive procedure continues through the remainder of the clinical program. FSOMA contrasts these licensure requirements with the “minimal study requirements” for PTs under the Proposed Rule. FSOMA notes that the Proposed Rule merely sets forth subject areas without requiring a minimum number of training hours and provides no direct supervision in a clinical setting before the PT may commence dry needling in their practice. FSOMA points to a policy statement issued by the American Medical Association (“AMA”) at its 2016 Annual Meeting stating that dry needling is “an invasive procedure and . . . should only be performed by practitioners with standard training and familiarity with routine use of needles in their practice, such as licensed medical physicians and licensed acupuncturists.” The press release announcing the AMA policy specifically mentioned PTs in terms of “lax regulation and nonexistent standards” surrounding the invasive practice of dry needling. FSOMA contends that section 486.021(11) generally prohibits PTs from performing invasive procedures. FSOMA argues that, with the exception of electromyography for diagnostic purposes, none of the practices within the scope of physical therapy practice are invasive. All of the therapeutic practices contained in the statute are non-invasive. FSOMA asserts that the Proposed Rule’s failure to require assurance of competence prior to the performance of dry needling means that the Board intends to ask for such assurance only after it receives a complaint that a patient has been injured by dry needling. FSOMA states that relying on after- the-fact enforcement of competency requirements does not adequately protect the public. Through Mr. Bibbey’s testimony, FSOMA introduced data indicating that the incidence of adverse events for dry needling is “about triple” that for acupuncture. Mr. Bibbey specifically referenced an article in the March 2015 edition of the journal Physiotherapy Alberta, titled “FAQ Dry Needling Adverse Events.” The authors compiled the results of several studies to conclude that the incidence of “adverse events” in acupuncture treatment is 8.6 percent. The incidence of adverse events in dry needling was found to be 19.18 percent. “Adverse events” included a very wide range of outcomes, from minor and expected things such as bruising, bleeding, and/or pain up to serious events such as pneumothorax. For both forms of treatment, the vast majority of adverse events was minor and required no follow-up treatment. FSOMA went on to argue that the similarity between acupuncture and dry needling means that the public could confuse the two, and that the adverse results caused by poorly trained PTs performing dry needling could harm the reputation of acupuncture in the state. Mr. Bibbey testified that allowing PTs to practice dry needling under the inadequate standards of the Proposed Rule “may lead to a chilling effect on the trust and use of acupuncture, both through patient harm and confusion over what is and what isn’t acupuncture.” George Parente, who is licensed in Florida as both a PT and an acupuncturist, agreed with Mr. Bibbey on the impact of dry needling by PTs on the practice of acupuncture. The lack of required training raises safety issues for the patient. If there are injuries caused by PTs conducting dry needling, the public will likely associate those injuries with the needle- insertion practices of acupuncturists. The cultural distinctions between acupuncture and dry needling will be lost on the general public. Mr. Parente asserted that there is no difference between acupuncture and the dry needling performed by PTs, though he conceded that he has no hands-on experience in dry needling. He believes that dry needling is just “a clever play on words at the very best.” The Board and FSOMA countered with testimony from their experts that the training standards set forth in the Proposed Rule are entirely adequate, that dry needling by PTs presents no greater risk to the public than does acupuncture, and that there is more than adequate evidence from other states that PTs performing dry needling has had no negative effect on the status of acupuncture. Dr. Dommerholt testified that 35 states already allow PTs to perform dry needling in their scope of practice, with no notable ill effects. Dr. Dommerholt has provided dry needling training and education in the United States since 1997 and founded Myopain Seminars, one of the country’s largest providers of dry needling education and training. Dr. Dommerholt is licensed as a PT in Maryland, where dry needling has been approved as a PT technique since 1984. Dr. Dommerholt testified that since 1984, the practice of acupuncture has grown substantially in Maryland, leading him to conclude that perhaps dry needling by PTs has a positive effect on the profession of acupuncture. Dr. Sillevis, who is licensed as a PT in Florida and Indiana, has extensively performed dry needling and is active in the profession nationally. Dr. Sillevis testified that he is aware of only one serious injury resulting from a PT performing dry needling since 2014, and this was outside the United States. In his experience performing dry needling, he draws a drop of blood in about one out of 25 patients. Dr. Sillevis' clinic was the first in Indiana to have PTs perform dry needling. Over time, dry needling by PTs has become more widespread in Indiana and the practice of acupuncture has grown. Dr. Sillevis testified that there were no acupuncture schools in his region when he started dry needling, but there are now two. He also noted an increase in the number of acupuncture clinics. Dr. Sillevis has observed the same thing in Boulder, Colorado, where acupuncture practice became more prevalent as PTs began dry needling. Dr. Sillevis has worked with acupuncturists and often refers patients to acupuncturists because of their abilities as clinicians. Acupuncturists perform their own assessments and do not need Dr. Sillevis to direct the course of care. Dr. Sillevis stated that a PT addresses a patient’s problem and solves it; the patient leaves and does not come back. An acupuncturist, on the other hand, “establishes a relationship for life.” Healthcare Providers Service Organization (“HPSO”) is the main malpractice insurance carrier for APTA. In a letter to APTA’s vice president for government affairs, dated January 24, 2018, the president of the healthcare division of HPSO discussed the risk experience of dry needling. For the five-year period ending in 2017, HPSO’s underwriter managed 3,413 PT claims. Out of those, 34 arose from the practice of dry needling, the most common injury alleged being pneumothorax. The 34 claims came from 19 different states, indicating that no single state was the driver of loss. The total incurred loss from dry needling claims was $341,290. From these numbers, HPSO’s underwriter did not foresee the practice of dry needling “as having any immediate claim or rate impact.” Dr. Adnan Sammour is a Florida licensed medical doctor trained in both acupuncture and dry needling, and accepted as an expert in both disciplines. Dr. Sammour supervises PTs and focuses roughly half his private practice on treatment of musculoskeletal pain. He testified that PTs are “the most qualified” to perform dry needling because they do “hands-on” work with patients and have a better depth of knowledge about the musculoskeletal system than other practitioners, including physicians. Dr. Sammour further opined that PTs performing dry needling in Florida will not pose an increased risk of patient injury. He testified that sticking the needle is “the easiest part” of acupuncture practice. Most of acupuncture training is about meridian theory and diagnosing the energy imbalance. He noted that unlicensed medical assistants use needles on patients, and that patients even inject themselves with insulin or testosterone without formal training. In his opinion, dry needling by PTs is “very safe.” Dr. Sillevis testified, “In essence, teaching somebody dry needling is extremely simple. It doesn’t take much to poke a hole in the skin, right? So the skill isn’t that difficult. It is how you use the skill is where the learning curve is.” Dr. Dommerholt testified that he was a co-author of one of the studies compiled by the authors of the Physiotherapy Alberta article cited by Mr. Bibbey. His study found that the risk of a significant adverse event in dry needling to be less than .04 percent. Dr. Dommerholt also believed that comparison of adverse events between acupuncture and dry needling is misleading because dry needling involves greater needle depth and more vigorous manipulation of the needle. Dr. Dommerholt, Mr. McElroy, Mr. Reed, Dr. Sillevis, and Mr. Rowe reviewed the Proposed Rule and opined that it provides adequate standards for PTs to safely perform dry needling in Florida and creates no increased risk of patient injury. Mr. Rowe added that he believes the Board “did a great job selecting the appropriate list of competencies.” Dr. Dommerholt testified that dry needling is a manual therapy that falls within the basic skill set of a PT. The APTA includes dry needling in its practice guide. Dr. Zylstra referenced a study produced by Human Resources Research Organization (“HumRRO”) for the Federation of State Boards of Physical Therapy (“FSBPT”) showing that 86 percent of the competencies needed for dry needling are already covered in physical therapy coursework, the other 14 percent being mostly about the safe handling of needles.6/ Robert Rowe is a PT who acts as the executive director of the Institute of Higher Learning at Brooks Rehabilitation Hospital in Jacksonville. He has taught PT for 25 years. Mr. Rowe testified that there are many states where PTs have been dry needling for years and have coexisted with acupuncturists “and nobody is going out of business and nobody is having problems.” He testified that he regularly refers to acupuncturists, has great respect for them, and would never advocate for something that would harm their profession. Mr. Rowe testified that FSOMA’s allegations of potential patient harm from PTs performing dry needling do not ring true. He noted that dry needling has been performed by PTs in many states for years, and that if there were high injury rates “our insurance would be skyrocketing.” Mr. Rowe made the common sense observation that if there were evidence that the acupuncture profession has been harmed in the states that allow PTs to perform dry needling, “that data would be presented in this hearing, because that’s powerful data . . . . [I]f it was true, it would exist and it would be presented. And I’m sure that that hasn’t been presented because it doesn’t exist because it’s untrue.” Based on the foregoing findings, it is found that FSOMA has failed to demonstrate that dry needling, as described at hearing and practiced by PTs in other states, would increase the potential for harm to patients in Florida. The Board and FPTA presented preponderant evidence affirmatively demonstrating the benefits of dry needling. The dangers cited by FSOMA were largely speculative, while the witnesses for the Board and FPTA testified as to the actual experience of patients in the states where dry needling by PTs is allowed. Because it is found below that dry needling is “acupuncture” as defined in section 457.102(1) and that section 486.021(11) as currently written does not allow PTs to practice dry needling in Florida, there is no need for an ultimate finding as to the adequacy of the training prescribed in the Proposed Rule. It is observed that if the Board did have statutory authority to adopt standards of practice for dry needling in the practice of physical therapy, then FSOMA would in all likelihood lack standing to challenge those standards. Confusion Mr. Bibbey testified that allowing PTs to introduce dry needling as “an alternate term” to describe acupuncture could lead to confusion over what is and is not acupuncture in Florida. Mr. Parente was concerned that the harm caused by inadequately trained PTs practicing dry needling will be associated with the profession of acupuncture. FSOMA offered no evidence of actual patient confusion in the 35 states that already allow PTs to perform dry needling. Dr. Dommerholt, Mr. McElroy, Dr. Zylstra, and Dr. Sammour opined that neither patients nor providers will confuse dry needling with acupuncture. Mr. McElroy testified that when he was stationed in Okinawa, he performed dry needling and supervised a physician’s assistant who performed acupuncture. Mr. McElroy stated that the procedures were thoroughly explained to patients and there was never any confusion about the differences between dry needling and acupuncture. Dr. Zylstra, who practices in Michigan, testified that he has had an acupuncturist working in his physical therapy clinic. He and members of his family have had acupuncture treatments. He stated that he refers patients for acupuncture if their complaints relate to a systemic disease process or if they complain of problems with sleep, stress, or allergies. Dr. Zylstra testified that once the use of the needle is explained to a patient, there is no confusion between dry needling and acupuncture. Mr. Reed likewise testified that if people come into his physical therapy office seeking acupuncture, he refers them to an acupuncturist. If a patient presents with something that Mr. Reed cannot treat, such as a head cold, he might refer that patient to an acupuncturist. Mr. Reed testified that he explains the difference between dry needling and acupuncture to patients as a precaution, having been cited for unlicensed activity by the Department of Health in 2016 for using dry needling in his practice. (The Department of Health subsequently withdrew the citation.) Mr. Reed stated that he always speaks highly of acupuncture when he talks to patients. It is understood that in the public mind, “acupuncture” has become the generic term for “therapeutic insertion of needles” in the same sense that “Kleenex” has become the generic term for “paper tissue.” FSOMA has a valid point that the general public could be confused by the concept of dry needling by PTs, at least until the practice comes into more common usage and understanding. However, there was no evidence provided that any such confusion has prevailed in the states where dry needling by PTs is allowed or that any actual patient of a PT did not understand the distinction between dry needling and acupuncture at the time of treatment. Based on the foregoing findings, it is found that FSOMA failed to demonstrate that the practice of dry needling by PTs in Florida would cause patients to confuse dry needling by a PT with acupuncture performed by a licensed acupuncturist. The Board and FPTA presented preponderant evidence affirmatively demonstrating that there is no appreciable patient confusion in states where PTs are allowed to perform dry needling. Invasive procedures As to the alleged prohibition in section 486.021(11) on PTs performing invasive procedures, the Board and FPTA respond that nothing in the cited statute provides for such an exclusion. They point out that the only techniques specifically prohibited by section 486.021(11) are found in paragraphs (b) and (c), not heretofore quoted: The use of roentgen rays and radium for diagnostic and therapeutic purposes and the use of electricity for surgical purposes, including cauterization, are not “physical therapy” for purposes of this chapter. The practice of physical therapy does not authorize a physical therapy practitioner to practice chiropractic medicine as defined in chapter 460, including specific spinal manipulation. For the performance of specific chiropractic spinal manipulation, a physical therapist shall refer the patient to a health care practitioner licensed under chapter 460. The Board and FPTA argue that FSOMA's construction of section 486.021(11) would render the specific exclusion of these techniques meaningless and unnecessary. The undersigned rejects this logic. The fact that the Legislature chose to expressly forbid PTs from engaging in certain specific practices does not mean that the Legislature intended to allow PTs to perform any and all other practices not expressly forbidden by the statute. Section 486.021(11) allows PTs to use “the physical, chemical, and other properties of air; electricity; exercise; massage; the performance of acupuncture only upon compliance with the criteria set forth by the Board of Medicine, when no penetration of the skin occurs; the use of radiant energy, including ultraviolet, visible, and infrared rays; ultrasound; water; [and] the use of apparatus and equipment in the application of the foregoing or related thereto.” (emphasis added). FSOMA argues that there is no conceivable reading of the quoted language that would define acupuncture needles as “apparatus and equipment” in the application of the enumerated treatment modalities. Indeed, counsel for FSOMA took most of the Board and FPTA’s expert witnesses through a litany of questions: “Does dry needling use the physical, chemical or other properties of air? Of electricity? Of exercise? Of massage? Does it use radiant energy? Ultrasound? Water?” The witnesses had to answer the questions in the negative. The Board and FPTA argue that “apparatus and equipment” must include the acupuncture needles used in dry needling, but are forced to rely on a negative implication: if FSOMA’s reading of the statute were correct, then PTs would also be denied the use of wound debridement tools such as scalpels, forceps, tweezers, and scissors, all of which are used by PTs in Florida to remove necrotic tissue from ulcers and wounds. Mr. Reed, who has experience performing wound debridement on burn victims and diabetic ulcers, credibly testified that debridement is an invasive procedure. The Board and FSOMA did not make an affirmative demonstration of the statutory and/or rule basis for PTs to perform wound debridement; they established only that debridement is in fact performed by some PTs. Dr. Dommerholt testified that PTs nationwide perform wound debridement in hospital settings, and Mr. Reed testified that he has done some debridement procedures in his clinics. Absent a demonstration of the statutory authority for PTs to perform debridement, the fact that PTs perform the procedure is of little assistance in determining whether section 486.021(11) authorizes PTs to perform dry needling. It should also be noted that the only provision of section 486.021(11) that expressly authorizes an invasive procedure places significant constraints on the performance of that procedure by a PT. The statute allows “the performance of electromyography as an aid to the diagnosis of any human condition only upon compliance with the criteria set forth by the Board of Medicine.” Florida Administrative Code Rule 64B8- sets forth the Board of Medicine’s prerequisites to the performance of electromyography by a PT: Pursuant to Section 486.021(11), F.S., the Board of Medicine sets forth the following criteria for the performance of electromyography by physical therapists. Before a physical therapist may perform electromyography as an aid to the diagnosis of any human condition, he must be trained and competent in: Inserting and adjusting electrodes. Reading and identifying normal and abnormal signals on the grid. Interpreting the audible signals. In addition to the requirements of subsection (1), a physical therapist must receive no less than the following formal education within an accredited post- secondary educational institution: Human dissection. Human physiology. Neurology. Neuro-anatomy and neuro-physiology offered at a graduate level. Pathological conditions. In addition to having completed the formal study requirements of subsection (2), outlined above, the physical therapist must have completed 200 hours of testing human subjects under the direct supervision of a licensed physician or licensed physical therapist who has previously met these qualifications and should be able to present evidence of having performed 100 tests on neurologically involved patients, with findings corroborated by a licensed physician or licensed physical therapist who has previously met these qualifications. Section 486.021(11) twice mentions invasive procedures. In the first instance, it forbids PTs from penetrating the skin when performing acupuncture. In the second, it requires compliance with the criteria set forth by the Board of Medicine. The Board of Medicine’s adopted criteria include proof of basic training and prerequisite coursework, 200 hours of supervised testing of human subjects, and 100 corroborated tests before a PT may perform electromyography. The Board of Medicine’s rule does not leave a PT free to act as the judge of his own competence in the area of electromyography, as FSOMA alleges the Proposed Rule would effectively allow for dry needling. Mr. Parente, who has been licensed as a PT since 1986, testified as to an “old adage” that applies to physical therapy: “Thou shalt not break the skin.” The experts testifying on behalf of the Board and FPTA uniformly rejected the notion that PTs are forbidden from performing invasive procedures. These experts may be correct in their general understanding of the current scope of practice for PTs in the United States. Nonetheless, section 486.021(11) governs the scope of practice in Florida and is found to contain a general presumption against PTs performing invasive procedures without prior demonstration of their qualifications and competence. More to the point of the instant case, section 486.021(11) includes a specific prohibition on the performance of invasive acupuncture procedures by PTs. I. Dry needling as acupuncture The statutory definition of acupuncture states that it “shall include . . . the insertion of acupuncture needles . . . to specific areas of the human body.” § 457.102(1), Fla. Stat. FSOMA compares the definition of acupuncture with the Proposed Rule’s definition of dry needling as “a physical therapist using apparatus or equipment of filiform needles to penetrate the skin and/or underlying tissues.” FSOMA argues that when PTs practice “dry needling” by inserting acupuncture needles into their patients, they are performing precisely the same acts that acupuncturists perform when they insert acupuncture needles into their patients. Mr. Bibbey opined that the similarity between dry needling and acupuncture is not limited to the use of acupuncture needles. He stated, “[I]t’s not simply just the tool. It’s the tool, the target tissue, the physiological effect, and the therapeutic effect are all one and the same with acupuncture and dry needling.” Mr. Bibbey’s description of the needling technique used in acupuncture was as follows: The procedure--you know, again, with the insertion of the needle is, again, identifying the target tissue, and depending on the target tissue in question, there can be manipulation of the needle, which would include a variety of techniques--twirling, spinning the needle, scratching the needle, lifting, thrusting the needle, pistoning the needle--a variety of techniques where you raise and drive the needle into the target tissue without removing the needle from the body. So you may insert to a depth, you’re going to bring it up to a depth just under the surface of the skin itself, and reapply it to the target tissue. FSOMA notes the similarity between Mr. Bibbey’s description of acupuncture technique and Mr. McElroy’s discussion of the “pistoning” used in dry needling to obtain a “twitch response.” See Finding of Fact 22, supra. Mr. Bibbey testified that although acupuncture’s theoretical basis lies in traditional Chinese medicine and dry needling is based on “western medical concepts,” the needling technique and therapeutic goals are essentially the same, regardless of the terminology used to express them. Mr. Bibbey opined that myofascial trigger points and acupuncture points “are one and the same.” Acupuncturists find acupuncture points by using the same technique of palpation that PTs use to locate trigger points. Mr. Bibbey testified that palpation and the location of trigger points for diagnostic and identification purposes are taught in acupuncture training. Mr. Parente also testified that dry needling and acupuncture are “one and the same.” He went on to say: I don’t see how you can separate the two. You’re using the same tool . . . . [T]echnically, there isn’t any place on the human body that doesn’t have some form of channel in terms of traditional Chinese medicine, and whether or not you’re even thinking along those lines, there’s other ways to apply them even within the realm of Chinese medicine, okay. So to me, I don’t know how you can separate the two. Unsurprisingly, the Board and FPTA disagree that dry needling is acupuncture. They concede FSOMA’s point that the statutory definition of acupuncture includes “the insertion of acupuncture needles . . . to specific areas of the human body.” However, they contend that a fair reading of section 457.102(1) should include the entire sentence in question: Acupuncture shall include, but not be limited to, the insertion of acupuncture needles and the application of moxibustion to specific areas of the human body and the use of electroacupuncture, Qi Gong, oriental massage, herbal therapy, dietary guidelines, and other adjunctive therapies, as defined by board rule. (emphasis added). The Board and FPTA point to Florida Administrative Code Rule 64B1-4.010, adopted by the Board of Acupuncture and titled, “Traditional Chinese Medical Concepts, Modern Oriental Medical Techniques.” They argue that this rule provides a definition of “specific areas of the human body” that distinguishes acupuncture from dry needling. Rule 64B1-4.010 provides: Traditional Chinese medical concepts and modern oriental medical techniques shall include acupuncture diagnosis and treatment to prevent or correct malady, illness, injury, pain, addictions, other conditions, disorders, and dysfunction of the human body; to harmonize the flow of Qi or vital force; to balance the energy and functions of a patient; and to promote, maintain, and restore health; for pain management and palliative care; for acupuncture anesthesia; and to prevent disease by the use or administration of: stimulation to acupuncture points, ah-shi points, auricular points, channels, collaterals, meridians, and microsystems which shall include the use of: akabane; allergy elimination techniques; breathing; cold; color; correspondence; cupping; dietary guidelines; electricity; electroacupuncture; electrodermal screening (EDS); exercise; eight principles; five element [sic]; four levels; hara; heat; herbal therapy consisting of plant, animal, and/or mineral substances; infrared and other forms of light; inquiring of history; jing-luo; listening; moxibustion; needles; NAET; observation; oriental massage--manual and mechanical methods; palpation; physiognomy; point micro-bleeding therapy; pulses; qi; xue and jin-ye; ryodoraku; san-jiao; six stages; smelling; tongue; tai qi; qi gong; wulun-baguo; yin-yang; zang-fu; Ayurvedic, Chinese, Japanese, Korean, Manchurian, Mongolian, Tibetan, Uighurian, Vietnamese, and other east Asian acupuncture and oriental medical concepts and treatment techniques; French acupuncture; German acupuncture including electroacupuncture and diagnosis; and, the use of laboratory test and imaging findings. (emphasis added). The Board and FPTA argue that the underscored language of the rule defines “specific areas of the human body” as “acupuncture points, ah-shi points, auricular points, channels, collaterals, meridians, and microsystems.”7/ They argue that these “specific areas” do not correspond to the areas of the human body treated by PTs in dry needling, essentially because the theories of acupuncture and dry needling are so different. As Dr. Dommerholt testified in a discussion of an academic study on the correlation between acupuncture points and trigger points, “[M]ost acupuncture points do not have a pain indication, which is the main indication of trigger points.” Mr. Bibbey, on the other hand, testified as to a high correlation between trigger points and acupuncture points, based on his broad definition of the latter. There are 14 meridian channels that cover 100 percent of the body and consist mostly of paired organs: the spleen and stomach; kidney and bladder; liver and gallbladder; lung and large intestine; heart and small intestine; pericardium and triple warmer; and du and ren. Mr. Bibbey explained that acupuncture points may or may not be located along defined meridians. Other acupuncture points are not predefined and must be identified by palpation. These acupuncture points, called “de-meridian,” provided the basis for Mr. Bibbey's opinion that “any target tissue that you put an acupuncture needle into becomes an acupuncture point.” Under Mr. Bibbey’s expansive definition, there would necessarily be a high correspondence between acupuncture points and trigger points, in the sense that it would be difficult to identify a trigger point that is not also an acupuncture point. Both sides offered academic articles on the subject of the correspondence, if any, between acupuncture points and myofascial trigger points. The articles introduced by the Board and FPTA were more recent and more methodologically rigorous, but both sets of articles constitute uncorroborated hearsay and are not relied upon herein. In the absence of contrary evidence, Mr. Bibbey’s credible expert testimony as to the 100-percent coverage of the body by the meridian channels is accepted. If the meridian channels include the entire body, then the language of Board of Acupuncture rule 64B1-4.010 emphasized by the Board and FPTA does not operate as a limitation on the statutory language that acupuncture includes “the insertion of acupuncture needles . . . to specific areas of the human body.” The plain reading of the Board of Acupuncture rule supports the conclusion drawn from Mr. Bibbey’s expert testimony. “Acupuncture points, ah-shi points, auricular points, channels, collaterals, meridians, and microsystems” is a laundry list that appears to cover every possible area of the human body. Mr. Bibbey’s testimony was that an “acupuncture point” is essentially any point on the human body into which an acupuncturist decides to place a needle. This testimony is not inconsistent with the definitional language of either the acupuncture statute or rule. The Board and FPTA offered no evidence that the quoted language in the rule operates as a limitation on the statutory language, beyond the clear theoretical differences between dry needling and acupuncture. It is accepted that dry needling does not approach the human body on the same theoretical basis as acupuncture. Dry needling is a specific technique used by PTs in treatment programs to alleviate pain and restore range of motion. Unlike acupuncture, dry needling is not an entire system of medicine. Nonetheless, dry needling is “the insertion of acupuncture needles . . . to specific areas of the human body.” Dry needling may not constitute the practice of acupuncture in any real world sense, but in the statutory sense it does. Because it meets the definition of “acupuncture” set forth in section 457.102(1), dry needling is prohibited in the practice of physical therapy by section 486.021(11), which allows PTs to perform acupuncture only “when no penetration of the skin occurs.” Tad Fisher, FPTA’s executive director, offered testimony that summed up the state of the law as to dry needling: “[T]he statutes don’t necessarily keep up with the evolution of the health care professions that they’re regulating . . . .” The evidence presented at the hearing demonstrated the safety and efficacy of dry needling as performed by PTs in other states, but could not overcome the plain, if perhaps outdated, language of the Florida Statutes.
The Issue There are three issues to be determined in this case: (1) whether the Petitioner, Arlington Ridge Community Association, Inc. (Arlington Ridge), demonstrated standing to challenge the proposed agency actions; (2) whether the terms of Consent Order OGC No. 18-0077 (proposed Consent Order) constituted a reasonable exercise of the Respondent, Department of Environmental Protection's (Department), enforcement discretion; and (3) whether the Department's notice of intent to issue minor source air construction permit 0694866-009-AC (009 Permit) to the Respondent, GI Shavings, LLC (GI Shavings), met the applicable rule and statutory criteria for issuance.
Findings Of Fact The Parties The Arlington Ridge community is located in Lake County comprising approximately 500 acres. The community is a 55-year- old plus active adult community with approximately 730 homes. The community includes an 18-hole golf course, swimming pool, tennis courts, pickle ball courts, walking trails, conservation areas, and common areas. Arlington Ridge is a Florida not-for-profit community association governed by its Declaration of Restrictive Covenants for Arlington Ridge, recorded on April 15, 2005, at Official Records Book 2809, Page 1622, of the Public Records of Lake County, Florida, as amended. Arlington Ridge's Articles of Incorporation demonstrate that it was formed, in part, to promote the health, safety, and welfare of the owners within its community and to provide for the ownership, operation, maintenance, and preservation of the common areas. Arlington Ridge is made up of the Declarant, CB Arlington Ridge Landco, LLC, as long as the Declarant still owns lots and the residents who own lots. Robert Salzman is vice president of the Declarant. He serves as president and is a member of the board of directors of the community association. The Declarant still owns 170 undeveloped lots and 91 lots that are under development. There are 730 existing homes that are owned by individual residents who are members of the community association along with the Declarant. The community association owns a section of the roadway and land around the rear gate of the subdivision. GI Shavings is a Florida limited liability company and is the applicant for the minor source air construction permit at issue in this proceeding. The GI Shavings property is located adjacent to the Arlington Ridge community. The address is 26444 County Road 33, Okahumpka, Lake County, Florida 34736. GI Shavings also signed the proposed Consent Order at issue in this proceeding. The Department is the administrative agency of the state having the power and duty to protect Florida's air and water resources and to administer and enforce the provisions of chapter 403, Florida Statutes, and rules promulgated thereunder in Florida Administrative Code Title 62 regarding activities which have the potential to cause air pollution. Facility History of Permitting and Operations On February 7, 2014, GI Shavings' predecessor, Quality Shavings of South Florida, LLC, applied to the Department for an initial air construction permit. The application described the proposed project as a wood chip dryer that included a 30 million British thermal unit per hour (mmBtu/hr) burner fueled by wood chips and sawdust. The burner provided heat to the rotary kiln chip dryer and exhausted to a cyclone dust separator prior to venting to the atmosphere through an exhaust stack. The application materials contained information about the United States Environmental Protection Agency's (USEPA) AP-42 emissions factors for combustion of wood products, with estimations of regulated air pollutant potential and estimated actual emissions from the wood chip drying process. The potential emissions for each pollutant and group of pollutants were listed in tons per year (TPY), and were based on a 30 mmBtu/hr facility running 8,760 hours per year, i.e., no hourly limit. The estimated actual emissions were based on the facility running a typical production schedule of 3,600 hours per year. The listed air pollutants were carbon monoxide (CO), nitrous oxides (NOX), particulate matter (PM), volatile organic compounds (VOCs), sulphur dioxide (SO2), carbon dioxide (CO2), and hazardous air pollutants (HAPs). Although there were potential emissions and estimated actual emissions for each pollutant and group of pollutants, the major source thresholds were not triggered. Therefore, the facility would be classified, from a regulatory standpoint, as a minor source of air pollution. The only air pollution control device was the cyclone dust separator that was rated at 99 percent removal efficiency for PM10, i.e., particulate matter of grain size 10 microns or less, from the exhaust airstream. The application reflected that there were no controls proposed for CO, NOX, VOCs, SO2, CO2, or HAPs. The application was silent as to control of fine particulates or PM2.5, i.e., particulate matter of grain size 2.5 microns or less. The application contained a site location map based on an aerial map. The proposed location of the facility was on a parcel adjacent to the Arlington Ridge community's golf course, and further east a road labeled as Arlington Ridge Boulevard. Other roads, in what appeared to be a not fully built-out subdivision, were White Plains Way and Manassas Drive. The facility plot plan in the application located the wood drip dryer, rotary kiln, cyclone dust separator and exhaust stack on the eastern end of the parcel closest to the boundary with the Arlington Ridge community's golf course. On April 4, 2014, the Department issued minor source air construction permit 0694866-001-AC (001 Permit). The 001 Permit established a visible emissions (VE) limit of five percent opacity, which is the limit specified under the materials handling rules. Like all air permits issued under the Department's rules, the 001 Permit was also subject to certain general conditions. These included the prohibition against "objectionable odor" as defined in the Department's air pollution rules. At the time the 001 Permit was issued, neither GI Shavings nor the Department recognized that the rules for carbonaceous fuel burning equipment were applicable to GI Shavings and that there should also have been a limit for PM in the 001 Permit. Instead, the rules for a materials handling operation were applied to the facility, which required a VE limit of five percent opacity. The 001 Permit required GI Shavings to demonstrate initial compliance and apply for an operating permit no later than 60 days before it expired on June 30, 2015. On December 18, 2014, the Department issued an amendment of the 001 Permit to grant a transfer of ownership from Quality Shavings of South Florida, LLC, to GI Shavings (002 Permit). On May 11, 2015, GI Shavings submitted a request for additional time to demonstrate initial compliance. The reason given for the request was that operations had not started because GI Shavings was waiting on a certificate of occupancy from Lake County, which was expected within the next 60 days. On May 28, 2015, DEP granted the request and issued a permit amendment (003 Permit), which extended the expiration date from June 30, 2015, to December 31, 2015. On November 24, 2015, GI Shavings submitted a second request for additional time to demonstrate initial compliance. The reason given for the request was coding issues at the new warehouse. The request noted that "[a]ll the equipment has been up and runs." On December 7, 2015, the Department granted the request and issued a permit extension (004 Permit), which extended the expiration date from December 30, 2015, to June 30, 2016. In the 004 Permit extension, the Department reminded GI Shavings that there must be notification to the Department within five days of commencing operations, compliance testing within 30 days of commencing operations, 15 days notification to the Department prior to compliance testing, and application for an initial air operation permit no later than 60 days prior to the new expiration date. On April 27, 2016, GI Shavings submitted a third request for additional time to demonstrate initial compliance. There was not any reason given for this 120-day extension request. On May 11, 2016, the Department granted the request and extended the permit's expiration date to October 31, 2016 (005 Permit). The Department reiterated the same reminders as in the 004 Permit extension. On October 24, 2016, the Department conducted its first formal site inspection of GI Shavings in response to complaints from Arlington Ridge residents about smoke, airborne PM, and odor. The Inspection Report confirmed it was a complaint inspection. The Inspection Report also stated that the Department's permitting engineer, Jeff Rustin, had made a previous site visit at which time he had requested to review facility records. The inspection revealed that GI Shavings had commenced operations without notifying the Department, and had not scheduled or submitted a VE compliance test to demonstrate compliance with the permit's five percent opacity limit. During the site inspection, Jeff Rustin and his supervisor, Tom Lubozynski, also a professional engineer, noted that GI Shavings was emitting white smoke from the exhaust stack that did not dissipate quickly and that the smoke may have both moisture and particulates. As they stood 60 feet from the burner and the burner's smoke stack, there was the odor of burning smoke, and particles fell onto Mr. Lubozynski's notepad. Based on their observations, the Department's engineers concluded that the cyclone dust separator was not adequately controlling PM emissions, that the method of operations was unlikely to keep emissions below the five percent opacity VE limitation, and that the equipment should not be operated, except for test purposes. On October 26, 2016, GI Shavings submitted a fourth request for additional time to demonstrate initial compliance. The request was for a 180-day extension with no reason given for the request. On November 23, 2016, the Department granted the request and extended the expiration date from October 31, 2016, to April 4, 2017 (006 Permit). The Department specifically stated in the 006 Permit that the facility was not authorized for normal operations and suggested the alternatives of adding another pollution control device in the form of a bag house, or replacing the cyclone dust separator. Despite the Department's limitations on operations stated in writing at the times of issuing the 004 and 005 Permit extensions, the credible and persuasive evidence was that GI Shavings operated throughout 2016 up until it hired Bruno Ferraro in late November 2016. Actions Taken Before Rerating the Burner Mr. Ferraro is the president of Grove Scientific and Engineering Company, and an expert in air emissions, combustion and visible emissions testing, and air permitting. Mr. Ferraro contacted the Department in early December 2016, stating that he was hired by GI Shavings to evaluate emissions and hoped to visit the facility that month. He requested the original emissions calculations and was provided the original air construction permit application, which contained that information. On December 22, 2016, Mr. Ferraro provided to the Department a report of his initial investigation of the GI Shavings facility. He conducted a site visit on December 20, 2016, accompanied by three representatives from the Department that included Jeff Rustin, Brianna Gowan, and Wanda Parker- Garvin. Ms. Parker-Garvin was the environmental manager for the Central District Office's compliance assurance program. Of particular relevance in the report was the following statement: The cyclone works as designed by separating the dry wood shavings and sawdust from the hot combustion air. However, the cyclone is not designed to remove fine particulates from the combustion of wood. The particulate matter (PM) emitted from the combustion of wood is unburned carbon and too small a particle size to be removed by the cyclone. This carbonaceous PM is best controlled by increasing the efficiency of combustion or through the use of post combustion control equipment. (Emphasis added). J. Ex. 1 at DEP 1-360. Mr. Ferraro recommended certain actions to increase the efficiency of combustion, such as changing the starter fuel to wood logs and varying the sawdust feed rate. He also recommended that GI Shavings seek a permit modification to allow excess emissions during startup, shutdown, and malfunction. He also recommended seeking a permit modification to allow a higher VE limit, such as 20 percent opacity, for normal operating conditions. He recommended, as a last resort, the use of post combustion control equipment. This would involve the installation of a bag house, which he described as a "very costly alternative and an excessive measure for controlling carbonaceous PM from the combustion of clean wood." The Department responded to Mr. Ferraro's report on January 5, 2017. Ms. Parker-Garvin provided the Department's comments and response in a lengthy email that also approved a two-week experimental testing phase. The email specifically limited opacity to no more than 20 percent for a smoke plume that would be carried by a west wind in an easterly direction toward the adjacent residents and golf course in a 90-degree quadrant designated on an aerial map as the area of concern or "AOC." The email summarized an expectation that a future air operation permit would require a showing of reasonable assurance that the relevant carbonaceous fuel burning rules for a 30 mmBtu/hr burner could be met. This would include a VE limit of 30 percent opacity and a PM limit of 0.2 pounds per mmBtu of heat input of carbonaceous fuel. Both limitations would need to be initially demonstrated before an air operation permit could be issued. On January 8, 2017, Mr. Ferraro provided a draft startup, shutdown, and malfunction operation plan (SSMOP) to the Department. In his email, Mr. Ferraro stated that the facility would start the two-week experimental testing phase the next day, on January 9, and keep the Department updated. He also stated that they would submit an application to modify the air construction permit. On January 17, 2019, GI Shavings applied for a permit modification, specifying only a change in VE limit from five percent opacity to 30 percent opacity. On March 8, 2017, the Department met with Mr. Ferraro, and an attorney for GI Shavings who attended by telephone. The meeting summary documented a discussion of issues that included requirements for annual PM testing, annual VE testing, and the SSMOP's restrictions on hours of operation and wind direction. The Department's response referred to "health concerns of the complainants," "adverse impacts off property," "numerous complaints," and "proximity to a retirement-age community" as reasons for the SSMOP's restrictions. On March 31, 2017, the Department's intent to modify GI Shavings' air construction permit was published. Arlington Ridge residents made verbal comments and filed complaints with the Central District Office regarding the draft air construction permit. The residents also filed a petition for administrative hearing that was eventually resolved in some manner, because the evidence showed that the final permit was issued on June 26, 2017. On June 26, 2017, the Department modified the air construction permit (007 Permit). The 007 Permit authorized a change in the VE limit, added a PM limit, added a SSMOP, added initial compliance requirements, and extended the expiration date to November 30, 2017. The 007 Permit also included a separate hours of operation agreement (HOA) between the Department and GI Shavings. The HOA initially provided for "[t]wo consecutive 8-hour shifts per day, between the hours of 6:00am and 10:00pm, Sunday thru Friday." These hours could be increased based on lack of compliance issues and lack of complaints over a 90-day period after the 007 Permit was issued. Mr. Ferraro testified that one of the permit requirements was to do a PM compliance test using EPA Method 5. This involved establishing a protocol that would be approved by the Department prior to conducting the compliance test. He testified that during June and July of 2017, the facility started having operational problems that made it difficult to calibrate the fuel feed system to establish the maximum fuel rate and the maximum shavings production rate. During calibration, the sawdust feed system motor kept burning out. Finally, he was able to schedule and conduct the PM compliance test on August 25, 2017. Mr. Ferraro testified that he ran the burner at maximum capacity during the test, which turned out to be an average of 18.252 mmBtu/hr. That is when he observed that this burner's maximum capacity was not 30 mmBtu/hr. The facility failed the PM compliance test with a three-run average PM of 0.531 pounds per mmBtu of heat input of carbonaceous fuel. The facility complied with the VE limit using the EPA Method 9 test, with the highest six-minute average of 13.33 percent opacity. The compliance test results were reported to the Department on September 8, 2017. In his report, Mr. Ferraro concluded "[i]t is our opinion that the PM caused by the burning of carbonaceous fuel, plus the process emission from the wood shavings dust combined in the method 5 sample filter to cause the observed PM emission rate." He stated that GI Shavings wanted to resolve the situation by exploring a change to the PM limit in the permit. Mr. Ferraro testified that there continued to be startup and operational difficulties at the facility. At maximum operation, the facility was not able to get the burner to the specified heat output of 30 mmBtu/hr. After multiple calibrations and tests, the facility was still unable to function as originally specified by the manufacturer. After consulting with the Department, Mr. Ferraro designed a demonstration test in which the sawdust fuel was fed into the burner without the drying of wood shavings. The demonstration test's purpose was to address the PM and VE from the combustion of sawdust. The test was conducted on October 11, 2017, and reported to the Department on October 30, 2017. The facility failed the PM test with a three-run average PM of 0.824 pounds per mmBtu of heat input of carbonaceous fuel. The facility complied with the VE limit using the EPA Method 9 test, with the highest six-minute average of 5.6 percent opacity. Mr. Ferraro concluded that the October test confirmed the PM measured was a result of unburned carbon or incomplete combustion of the carbonaceous fuel, i.e., sawdust. He stated that the cyclone dust separator appears to do a good job of removing all large PM. However, the burner was not designed for complete combustion, i.e., did not burn hot enough for long enough. This resulted in the black soot deposited on the method 5 filters during the compliance tests. Meanwhile, on October 10, 2017, Mr. Ferraro forwarded an email to the Department with a request from GI Shavings to increase its hours of operation since it was "commencing our six months busy season," and was negotiating with additional clients. After receiving the initial October 10, 2017, test results from Mr. Ferraro, the Department's permitting program administrator at the time, Kimberly Rush, responded that "[b]ased upon the requirements outlined in the [HOA], the Department cannot approve the request[ed] hours of operation change at this time due to the pending compliance test and the complaint received on 8/16/17." Mr. Ferraro testified that GI Shavings decided to bring in Energy Unlimited Inc., the equipment manufacturer, to commission the facility. At this time, GI Shavings, through Mr. Ferraro, also requested an extension of the air construction permit that was set to expire in December of 2017. The reason given was that more time was needed to conduct and complete the commissioning process and continue working on facility compliance. On November 20, 2017, the Department extended the expiration date of the air construction permit to November 30, 2018 (008 Permit). The 008 Permit did not make any other changes to the provisions and requirements of the 007 Permit. In January 2018, the manufacturer did significant work to the facility's systems including reworking the fuel feed system, installing a new programmable logic controller and temperature controllers, as well as mechanical and programmatic changes. Upon completion of the commissioning process, Energy Unlimited, Inc., certified and rerated the equipment at a design rate maximum of 26 mmBtu/hr and an actual rate of 21 mmBtu/hr. Mr. Ferraro testified that typical operation was between 15 and 18 mmBtu/hr depending on the temperature outside and the amount of moisture in the air. Impacts to Arlington Ridge Residents Dennis Hartman lives on Arlington Ridge Boulevard and has been a member of the community association since early 2018. Mr. Hartman testified that GI Shavings is located on a diagonal from his home adjacent to the 11th fairway of the golf course. He testified that the smoke and smell from GI Shavings irritates his lungs, throat, and nasal passages. Mr. Hartman testified that he is impacted by the facility, in this manner, at least twice a week. Notably, he does not experience these impacts when he is away from Arlington Ridge. James Piersall has been a member of the community association since July 6, 2018, when he closed on his home in Arlington Ridge. Mr. Piersall testified that on November 27, 2018, while playing golf on the 11th hole, a dark blue wave of smoke came across and covered the green. The smell was prevalent, which he equated to burning wood. Mr. Piersall captured the smoke on video with his cell phone. He testified that it was common knowledge that GI Shavings was located on the other side of the 11th hole. The 150-yard marker and a cell tower serve as landmarks that help the residents locate the GI Shavings facility. Mr. Piersall also testified that this was the time of year to open the windows and doors, and let the breeze blow through the house. However, it was not possible to do so, as there was "sediment and soot that comes out on the patio." Rhonda Lugo has lived in Arlington Ridge since August of 2014, and has been a member of the community association. She testified that GI Shavings began operating two years after she moved to Arlington Ridge. She lives on Arlington Ridge Boulevard, where her home is directly behind GI Shavings and her backyard is approximately 300 yards from the facility. Ms. Lugo testified that her first two years in her home were great. She used her lanai and enjoyed her home. She now describes her home as "unlivable." She does not open any doors or windows, and has not used the lanai for almost two years. The soot and ash covers her lanai furniture. She testified that her eyes burn, and described the odor as more than "just a wood burning smell." Ms. Lugo testified that over the last two years, the residents as a group, have gone to the City of Leesburg and to Lake County, have written senators and state representatives, and have contacted the Department many times. Cheryl Thomack has lived on Arlington Ridge Boulevard since August 2017, and has been a member of the community association. She experiences headaches and breathing difficulties, and uses an inhaler, which she attributes to smoke and soot from the GI Shavings facility. She testified that she went on vacation for a week away from her home and did not experience any headaches or breathing problems while away from Arlington Ridge. She also testified that the GI Shavings facility has operated when the wind is blowing in the direction of the community. Michael Becker has lived on Manassas Drive in the Arlington Ridge community since August 4, 2017. Mr. Becker enjoys the outdoor activities at the Arlington Ridge community and is a member of the softball team. He testified that the operations of the GI Shavings facility are disruptive to himself and his wife, and that they stay indoors with all windows and doors closed. He testified that they only enjoy their lanai in the late hours of the night, when GI Shavings is not operating. He described the smoke fumes as "pretty toxic" when the wind is blowing their way, with a scorched wood type of smell. Mr. Becker testified that he and his wife have taken several videos of dark smoke billowing from the GI Shavings facility, and provided them to the community association representatives. Mr. Becker also testified that he was aware of the location of at least two industrial facilities near the Arlington Ridge subdivision. He testified that Covanta, a clean waste facility, was located outside the subdivision's gate, and, what he believed was a cement plant, was located off Rogers Industrial Park Road. Douglas Deforge has lived on Manassas Drive since December 2017. He testified that when he first moved in, there was "a lot of noise and I saw a lot of smoke coming out of the trees that are behind us." Eventually, he figured out that it was the location of the GI Shavings facility. Mr. Deforge testified that his wife likes to go out on the lanai to drink her coffee and read the paper, but she is not able to do so on certain days when the machinery is running. Particles on the lanai have to be removed frequently. Mr. Deforge testified that the smoke has a pungent odor like a paper mill. He expressed concern that he may eventually have respiratory issues because of the particles he inhales when out on his lanai. Mr. Deforge testified that since late November 2018, up until the morning of the final hearing, "[i]t seems more frequently that I'm seeing plumes coming out of GI Shavings." Sherry O'Brien lives on Arlington Ridge Boulevard and has been a member of the community association since October 2014. The GI Shavings facility is directly behind her home across the 11th fairway of the golf course. She has even walked the fence line at the 11th fairway to locate GI Shavings' smoke stack. Ms. O'Brien testified that the dark smoke and odor from the GI Shavings facility prevents her from enjoying the lanai and from golfing. She experiences a more hoarse and raspy voice and sinus problems. Ms. O'Brien testified that even with the windows closed, inside her home smells like burning wood. She testified that she observed the smoke directly behind the 11th green, which is directly behind her home. In her testimony, Ms. O'Brien distinguished between the location of smoke from the GI Shavings facility and the Covanta facility. Robert Salzman has been at Arlington Ridge for several years, four to five days per week, 10 to 12 hours per day. He is involved with the day-to-day activities of the sales office, community association management; and he is on the architectural control committee. He testified that GI Shavings' operations impact the 11th and 12th holes of the golf course, which is still owned by the Declarant. Mr. Salzman testified that resident complaints about GI Shavings have increased over the years, particularly in the months of October and November when the operations increase from five to seven days per week and into the night. He testified that while GI Shavings is operating, the residents are not active outdoors, they do not seem to leave their homes, and golfers skip the 11th and 12th holes. Mr. Salzman testified that he was familiar with the industrial facilities around Arlington Ridge. He testified to the locations of an adjacent peat facility, an aggregate company, and the Covanta waste-to-energy facility. He testified that there was not a cement plant nearby, but that it was a concrete mixing company. Mr. Salzman also testified that Covanta has a giant stack that puts out steam, but it is not located in the same direction as the GI Shavings facility. All the residents who testified stated that they get "black stuff" on their lanais when there is smoke coming from GI Shavings. The residents also testified that they cannot open their windows and cannot enjoy their lanais. All the residents believed that an increase in hours of operation and no restriction on wind direction for GI Shavings would negatively impact their quality of life. Complaints to the Department The preponderance of the competent and substantial evidence showed that the residents lodged complaints with the community association, the Department, and the local governments about GI Shavings' operation for most of 2016, 2017, and 2018. The complaints increased in October of each year when GI Shavings increased operations to meet business demands. The complaints varied from the operations being a nuisance and affecting their quality of life in their retirement community, to genuine concerns for their health and well-being. During the hearing, GI Shavings tried to suggest that its facility was not the source of the smoke seen and videoed by the residents. Although the Arlington Ridge subdivision is adjacent to an industrial park, the residents' description and observation of GI Shavings' location behind the tree line at the 11th hole of the golf course was consistent and was supported by the preponderance of the competent and substantial evidence. Arlington Ridges' expert witness, Mitchell J. Hait, Ph.D., and GI Shavings' expert witness, Mr. Ferraro, both provided similar descriptions of the atmospheric conditions during the summer and winter months. They explained that during the winter months, when the atmospheric conditions are cooler, the plume from the exhaust stack does not dissipate as quickly as during the warmer summer months. Thus, the plume would tend to remain visible and be carried by the wind. The increase in residents' complaints starting in October of each year could be explained by a combination of the cooler atmospheric conditions and GI Shavings' increased operations to meet business demands. GI Shavings tried to suggest that the plumes were only comprised of steam from the drying process and that PM was removed at 99 percent efficiency by the cyclone dust separator. However, the preponderance of the competent and substantial evidence established that the cyclone dust separator did not remove fine PM identified as "unburned carbon . . . too small a particle size to be removed by the cyclone." In other words, the "black stuff" that the residents found on their lanais, and the odor that irritated their noses, throats, and lungs. Enforcement and Consent Order Despite overwhelming lay and expert evidence of ongoing objectionable odor violations, the Department sought only to resolve the August and October 2017 PM emission limit exceedances with the proposed Consent Order. Even though both Mr. Ferraro and Ms. Rush agreed that the October 2017 test was not run under normal operating and compliance conditions, the Department decided to label it as a violation in the proposed Consent Order. The proposed Consent Order gave GI Shavings a choice of corrective actions, and did not impose any monetary penalty. The choice given was to either install a pollution control device, such as a bag house, or perform a rerating of the burner. The preponderance of the competent and substantial evidence established that the cyclone dust separator did not remove the fine PM that was the source of the residents' objectionable odor complaints. The adequate and reasonable course of action would be to order GI Shavings to both install a bag house and perform the rerating of the burner. Instead, GI Shavings was allowed to rerate the unit and apply for the associated permit that would remove the requirement of a PM emission limit. Notably, the proposed Consent Order was not finally executed until April 20, 2018, at which time GI Shavings had already rerated the facility, applied for a permit, and received a notice of intent to issue with the draft 009 Permit. These completed actions were even stated in the proposed Consent Order. The Department's expert witness, Ms. Rush, testified that considering the difficulties with the facility's operations at its original specifications, rerating the burner was a viable option for obtaining compliance. However, giving GI Shavings a choice of corrective actions, which allowed it to avoid addressing the objectionable odor complaints, was not an adequate and reasonable exercise of the Department's enforcement discretion under the facts and circumstances described above. 009 Permit Application On January 31, 2018, Mr. Ferraro, on behalf of GI Shavings, submitted the 009 Permit application to the Department. Mr. Ferraro testified that the purpose of the application was to apply the correct part of the carbonaceous fuel burning equipment rule to the facility. The switch would be from the standards applicable to a 30 mmBtu/hr burner to the standards applicable to a less than 30 mmBtu/hr burner. This switch would entirely remove the PM limit and change the VE limit to 20 percent opacity. Mr. Ferraro testified that the application did not request any other change, and the Department did not request any additional information. The application described its purpose as "to update emission limiting standard for carbonaceous [fuel] burning equipment with a rating of less than 30 mmBtu/hr." The emissions unit control equipment was described as a single cyclone device that "separates wood shavings and sawdust from airstream, but does not control products of combustion." Although the inability of the cyclone dust separator to "control products of combustion" was acknowledged, the application indicated that PM would not be synthetically limited, and that a PM limit would not apply to the facility. The application did not propose a pollutant control device for the continuously acknowledged unburned carbon described as "too small a particle size to be removed by the cyclone." Ms. Rush testified that the only PM expected from the facility was PM10. However, as Mr. Ferraro pointed out in his testimony, actual site specific information and data should be considered whenever it is available, instead of simply relying on what is expected based on the literature from the USEPA. The 009 Permit's notice of intent to issue also stated that "the operational hours agreement has been removed from the permit," although GI Shavings did not apply for any change to the 008 Permit beyond the rule switch. Ms. Rush testified that the HOA was voluntary and the Department did not have the authority to require GI Shavings to incorporate these terms into future permits. However, the HOA continues to be a condition of GI Shavings' current 008 Permit. The Department and GI Shavings did not present any persuasive evidence to show that this condition was now obsolete and should not be carried forward into the 009 Permit. The 009 Application did not request any revision to the current SSMOP. Ms. Rush testified that any minor source air permittee may request to revise its SSMOP at any time. However, such a request would be subject to Department approval as specified in condition A.15. of the draft 009 Permit. Although Dr. Hait testified that the facility should be reviewed as a 30 mmBtu/hr burner, the more persuasive evidence was that the rerating by the manufacturer established a design fire rating of 26 mmBtu/hr and an actual rating of 21 mmBtu/hr. Ms. Rush testified that the draft 009 Permit would contain a feed rate limitation that would restrict the facility to a maximum firing rate of 21 mmBtu/hr. Thus, the carbonaceous fuel equipment burning rule was the most appropriate category for this facility, and it was appropriately regulated as a minor source of air pollution. The preponderance of the competent and substantial evidence proved that GI Shavings did not provide reasonable assurance that the facility would control the cause of the objectionable odor violations, i.e., fine PM identified as "unburned carbon . . . too small a particle size to be removed by the cyclone." In other words, the "black stuff" that the residents had constantly and consistently complained about. Ultimate Findings The preponderance of the competent and substantial evidence established that the GI Shavings facility emits fine PM or "black soot" into the outdoor atmosphere, which by itself or in combination with other odors, unreasonably interferes with the comfortable use and enjoyment of life or property at the Arlington Ridge community, and which creates a nuisance. The preponderance of the competent and substantial evidence established that the cyclone dust separator did not remove the fine PM that was the source of the residents' objectionable odor complaints. Therefore, it was an unreasonable exercise of enforcement discretion for the Department to not require that GI Shavings directly address the objectionable odor issue. In addition, the utility of entering the proposed Consent Order was diminished by the fact that the October 2017 alleged violation was not an appropriate compliance test. Also, by the fact that the proposed Consent Order was not finally executed until April 20, 2018, at which time GI Shavings had already rerated the facility, applied for a permit, and received a notice of intent to issue with the draft 009 Permit. The preponderance of the competent and substantial evidence proved that GI Shavings did not provide reasonable assurance that the facility would control fine PM, which the evidence established was the source of the residents' objectionable odor complaints. All other contentions that Arlington Ridge raised in this proceeding that were not specifically discussed above have been considered and rejected.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department enter a final order denying GI Shavings' application for minor source air construction permit 0694866-009-AC, and disapproving Consent Order OGC No. 18-0077. DONE AND ENTERED this 19th day of June, 2019, in Tallahassee, Leon County, Florida. S FRANCINE M. FFOLKES Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 19th day of June, 2019. COPIES FURNISHED: Stephen "Toby" Tobias Snively, Esquire Law Offices of John L. Di Masi, P.A. 801 North Orange Avenue, Suite 500 Orlando, Florida 32801 (eServed) John L. Di Masi, Esquire Law Offices of John L. Di Masi, P.A. 801 North Orange Avenue, Suite 500 Orlando, Florida 32801 Dorothy E. Watson, Esquire Foley & Lardner, LLP 111 North Orange Avenue, Suite 1800 Orlando, Florida 32801 (eServed) Matthew J. Knoll, Esquire Department of Environmental Protection Office of the General Counsel Douglas Building, Mail Station 35 3900 Commonwealth Boulevard Tallahassee, Florida 32399-3000 (eServed) Peter A. Tomasi, Esquire Foley & Lardner, LLP 777 East Wisconsin Avenue Milwaukee, Wisconsin 53202-5306 Lea Crandall, Agency Clerk Department of Environmental Protection Douglas Building, Mail Station 35 3900 Commonwealth Boulevard Tallahassee, Florida 32399-3000 (eServed) Justin G. Wolfe, General Counsel Department of Environmental Protection Legal Department, Suite 1051-J Douglas Building, Mail Station 35 3900 Commonwealth Boulevard Tallahassee, Florida 32399-3000 (eServed) Noah Valenstein, Secretary Department of Environmental Protection Douglas Building 3900 Commonwealth Boulevard Tallahassee, Florida 32399-3000 (eServed)
Findings Of Fact Petitioner took the massage exam in November, 1984, and received a passing grade of 81 on the written portion and a failing grade of 69.5 on the practical portion of the exam. A grade of 70 is required on both portions in order to pass the exam. It is the contention of the Petitioner that his practical exam score should be "rounded off" to a 70, thereby giving him a passing grade on both portions of the exam. He also disputes the grades given him on the practical portion, pointing out that there was a wide variation of 18 points between the grades he received from the two examiners, and he asserts that this should call into question the validity of the grades he was given. The evidence shows that the rules and policies of the Board of Massage do not authorize the practice of rounding off grades, as some other professions do. Therefore, there is no evidence upon which to base a finding that Petitioner's grade should have been rounded off. Expert testimony offered by Respondent establishes that all examiners are carefully selected as experienced licensees with at least five years experience, and are trained in examination procedures before they participate in an exam. Examiners also go through a "standardization" exercise before the exam in order to minimize disparity in grading. An analysis of the two examiners who graded Petitioner's exam shows that the examiner who gave Petitioner a 78 gave a mean grade of 86.85 to all candidates examined during the November exam, and the examiner who gave him a 60 gave a mean grade of 84.02. Each of these examiners agreed with other examiners in the November exam over 97 percent of the time. Of the 352 candidates who took the November exam, only nine failed (4 percent). Thus, grades were generally very high, and according to the expert in examination testing and measurement there is an extremely high degree of reliability in the grades given on this practical exam.
Recommendation Based upon the foregoing findings of fact and conclusions of law, it is recommended that a Final Order be issued dismissing the petition filed by Michael V. Oswalt. DONE and ENTERED this 20th day of June, 1985 at Tallahassee, Florida. Hearings Hearings DONALD D. CONN, Hearing Officer Division of Administrative The Oakland Building 2009 Apalachee Parkway Tallahassee, Florida 32301 (904) 488-9675 Filed with the Clerk of the Division of Administrative this 20th day of June, 1985. COPIES FURNISHED: Michael V. Oswalt 2735 N.W. 55th Blvd. Gainesville, Florida 32606 H. Reynolds Sampson, Esquire Department of Professional Regulation 130 N. Monroe Street Tallahassee, Florida 32301 Linda Biedermann Executive Director Board of Massage 130 N. Monroe Street Tallahassee, Florida 32301 Salvatore A. Carpino, Esquire Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301 Fred Roche, Secretary Department of Professional Regulation 130 North Monroe Street Tallahassee, Florida 32301
The Issue Whether during the relevant audit period, Respondent, Mary Cecilia Crosby, D.D.S. ("Dr. Crosby"), an oral and maxillofacial surgeon, was overpaid for services that, in whole or in part, were not covered by Medicaid, were not medically necessary, were improperly coded, or were insufficiently documented; and, if so, in what amount and what is the appropriate penalty.
Findings Of Fact The Parties This case arises from an AHCA Medicaid audit of Dr. Crosby for services provided and paid for during the period July 1, 2011, through December 31, 2014. Dr. Crosby is an oral and maxillofacial surgeon, licensed to practice in Florida, who began her dental practice in 1987 after receiving her dental degree from Ohio State University College of Dentistry and a certificate for oral and maxillofacial surgery from Columbia University. Dr. Crosby maintains her practice in Royal Palm, Florida. AHCA does not contend that Dr. Crosby provided poor quality of care. It also does not claim that her billings were fraudulent. The Florida Legislature has designated AHCA as the single state agency authorized to make payments for medical assistance and related services under Title XIX of the Social Security Act ("Medicaid program"). AHCA oversees and administers the Medicaid program for the State of Florida. § 409.913, Fla. Stat. AHCA investigates and audits Medicaid providers to identify and recoup overpayments for services rendered to Medicaid recipients. The Legislature also empowered AHCA to impose sanctions and fines against providers that received overpayments. § 409.913, Fla. Stat. In the Medicaid program, providers bill AHCA for services rendered and AHCA pays the bills, also called claims. Later AHCA audits the claims. This audit includes examination of whether the services were proper, whether the amounts billed were correct, and whether Medicaid covers the services provided. If AHCA determines that it overpaid a provider, AHCA seeks reimbursement of the funds. The Medicaid program follows a process of record collection, records analysis, provider input, and rebuttal from the provider before reaching its final determination of amounts overpaid. AHCA issues a FAR, sometimes amended, stating its determination and the reasons for it. If the provider disputes AHCA's final determination, it may request a formal administrative hearing. The Audit Process AHCA audited Dr. Crosby's claims and agency payments made during the period July 1, 2011, through December 31, 2014 (the "audit period"). During the audit period, Dr. Crosby was an enrolled Medicaid provider subject to the requirements of the Medicaid provider agreement. The Medicaid provider agreement is a contract between AHCA and the provider. It requires the Medicaid provider to comply with all state and federal laws establishing and regulating the Medicaid program. This includes Florida Medicaid Provider General Handbooks ("Provider General Handbooks") that are incorporated by reference into rules. The agreement required Dr. Crosby to maintain medical records and make those records available to AHCA in a systematic and orderly manner for review. The records must be accessible, legible, and comprehensive. AHCA uses a statistical sampling and extrapolation process for conducting Medicaid audits. Administrator Robi Olmstead provided the framework by which this audit was opened, investigated, reviewed, and reported. The process involves identifying and analyzing a randomly selected number of claims paid during the audit period. AHCA extrapolates the results of the analysis of the selected claims to the amount of claims paid during the audit period to determine the amount of overpayment, if any. The process of statistical sampling and the statistical methods used to establish the validity of the overpayment calculation in this case is an accepted and valid process that complies with section 409.913(20). AHCA's application of this process in this case is consistent with the requirements of all applicable versions of the Provider General Handbooks and Dental Services Coverage and Limitations Handbooks ("Dental Handbooks"), Current Dental Terminology ("CDT") manual definitions, Current Procedural Code ("CPC") definitions, Florida Statutes regulating dentistry, and dental standards of care to guide his evaluation. AHCA's application of the claims sample program resulted in the selection of the records of 35 of Dr. Crosby's patients. AHCA then asked Dr. Crosby to submit records and other documents to support her claims for the 35 patients. Dr. Crosby provided documents, including her medical records and billing records. Agency employees and a contracted expert, John H. Hardeman, D.D.S., M.D., reviewed the records. Dr. Hardeman is a Florida-licensed medical doctor and dentist, who is board- certified in oral and maxillofacial surgery. Dr. Crosby stipulated and agreed that Dr. Hardeman meets the requirements and qualifications of a "peer" as defined in section 409.9131. Dr. Hardeman's testimony is credible. The Audit Reports AHCA preliminarily concluded that it had overpaid Dr. Crosby $862,226.96. AHCA advised Dr. Crosby of its conclusion in a Preliminary Audit Report ("PAR"). This report and its attached worksheets explicated AHCA's rationale for its conclusions. AHCA provided Dr. Crosby an opportunity to provide additional records to support her claims, and to explain the questioned billings, but Dr. Crosby provided no further records. AHCA issued the FAR, seeking repayment from Dr. Crosby in the amount of $862,226.96 as a Medicaid overpayment for paid claims that, in whole or in part, are not covered by Medicaid. AHCA sought to impose a fine of $50,000.00 as a sanction for violations of rule 59G-9.070(7)(e). AHCA also claims that Respondent should pay investigative, legal, and expert witness costs, pursuant to section 409.913(23). Prior to the final hearing, AHCA performed further revisions and seeks $841,666.43 from Dr. Crosby as a Medicaid overpayment; seeks to impose upon Respondent a reduced fine of $49,000.00 for violation of rule 59G-9.070(7)(e); and also seeks payment of costs pursuant to section 409.913(23). The FAR identified four categories of shortcomings, resulting in reductions in payments for claims, under the heading "Findings" as follows: The 2008 and 2012 Florida Medicaid Provider General Handbooks, page 5-4, state that when presenting a claim for payment under the Medicaid program, a provider has an affirmative duty to present a claim for goods and services that are medically necessary. A review of your medical records by a peer consultant in accordance with Sections 409.913 and 409.9131, F.S. revealed that the medical necessity for some claims submitted was not supported by the documentation. Payments made to you for these services are considered an overpayment. (NMN) The 2008 and 2012 Florida Medicaid Provider General Handbooks, page 5-4, require that when presenting a claim for payment under the Medicaid program, a provider has an affirmative duty to present a claim that is true and accurate and is for goods and services that have actually been furnished to the recipient. A review of your medical records revealed that some services rendered were erroneously coded on the submitted claim. The appropriate dental code was applied. These dental services are not reimbursable by Medicaid. Payments made to you for these services are considered an overpayment. (ERROR IN CODING) The 2008 Florida Medicaid Provider General Handbook, pages 2-57 and 5-8 and the 2012 Florida Medicaid Provider General Handbook, pages 2-60 and 5-9, define incomplete records as records that lack documentation that all requirements or conditions for service provision have been met. A review of your medical records revealed that the documentation for some services for which you billed and received payment was incomplete or was not provided. Payments made to you for these services are considered an overpayment. (INSUFFICIENT/NO DOC) The 2007 Dental Services Coverage and Limitations Handbook, page 2-1 through 2-4, and pages 3-1 through 3-8, and the 2011 Dental Services Coverage and Limitations Handbook, page 2-1 through 2-5, state that only those services designated in the applicable provider handbook and fee schedule are reimbursed by Medicaid after the correct code was assigned. Payments made to you for these services are considered overpayments. (NOT A COVERED SERVICE). Bone Grafting--Coding Issues Most of the claims in dispute in this case involve whether procedures identified by Dr. Crosby as bone grafting, following the extraction of molars or wisdom teeth, were medically necessary or properly coded as procedures covered by Medicaid. The Florida Medicaid Dental Program, at the time of the audit, was limited in scope in the services and treatments available. The program does not cover preventive care. For the procedures in question, Dr. Crosby used CPC codes 21210 and 21215, which are codes for face bone and lower jaw bone grafts, respectively. Dr. Hardeman opined that the appropriate code for the procedures performed by Dr. Crosby is CDT Code D7953, which is not a Medicaid-covered procedure. CPC Code 21210 is for a graft in the upper jaw and described as "[g]raft, bone: nasal, maxillary or malar areas (includes obtaining graft)." CPC Code 21215 is for a graft in the lower jaw and described as "[m]andible (includes obtaining graft)." Significantly, the CPC manuals in effect during the years of the audit provide an introduction to the graft codes which states: Codes for obtaining autogenous bone, cartilage, tendon, fascia lata grafts, or other tissues through separate skin/fascial incisions should be reported separately unless the code descriptor references the harvesting of the graft or implant (eg., includes obtaining graft). (Emphasis added). CDT Code D7953 states as follows: bone replacement graft for ridge preservation--per site Osseous autograft, allograft or non-osseous graft is placed in an extraction site at the time of the extraction to preserve ridge integrity (e.g., clinically indicated in preparation for implant reconstruction or where alveolar contour is critical to planned prosthetic reconstruction). Membrane, if used should be reported separately. In laymen's terms, CPC codes 21210 and 21215 are for complex bone grafting involving a fairly extensive surgical procedure, including the harvesting of bone from the patient's body or that of a cadaver, and filling in or reconstructing a portion of the jaw. These codes apply when the bone grafting procedures are required because of traumatic or genetic defects and relate to large areas of reconstruction, not a single socket. None of the recipients who received bone grafts coded as CPC 21210 and 21215 had a traumatic injury. The Coding Guide for CPC codes 21210 and 21215, respectively, state that these grafts "may be held in place with wires, plates or screws" and the graft "shall be firmly positioned with wires, plates or screws". Dr. Crosby did not use plates, wires, or screws in any of the bone grafting procedures at issue. Dr. Crosby did not harvest any bone from any recipient but purchased the bone putty material from a manufacturer. Her belief, that taking putty out of a jar for a graft, constitutes "obtaining graft" is inconsistent with the CPC explanation of grafts for purposes of codes 21210 and 21215. These codes clearly require harvesting the bone material. Dr. Hardeman credibly testified that the procedures performed, with one exception, which was then allowed by AHCA post-FAR, were socket or ridge preservation grafts more appropriately coded as D7953. However, D7953 is a dental code that is not available for billing to Medicaid. That code is not present in the Dental General Fee Schedules or the Dental Oral/Maxillofacial Surgery Fee Schedules for any of the years of the audit period. Dr. Hardeman explained that it would take a competent oral surgeon from 15 to 20 minutes to remove impacted wisdom teeth and "just a few brief moments" to perform the bone grafting procedures Dr. Crosby billed to Medicaid and which are the subject of this audit. However, Dr. Crosby billed and received payment from Medicaid for bone grafting procedures at rates as high as $2,256.56. Agreements Reached During Final Hearing At final hearing, Dr. Crosby testified on her own behalf and presented the testimony of her expert witness, Dr. Robert Marx, D.D.S., who is also an oral and maxillofacial surgeon. Despite the claims in the Petition for Formal Administrative Hearing and the Amended Joint Prehearing Stipulation, at the final hearing, further agreement was reached on certain claims. Recipient 10, claims 5 through 12, were withdrawn because Dr. Crosby acknowledged the records/claims were actually for someone other than the recipient (they belonged to a sibling of the recipient). These claims were properly denied by AHCA. Also, in his final hearing testimony, Dr. Marx agreed with Dr. Hardeman's conclusions that AHCA properly denied the claims for the following: Recipient 4, claim 2; Recipient 5, claims 3, 13, 15, and 181/; c. Recipient 10, claim 2; d. Recipient 13, claim 2; e. Recipient 16, claim 7; f. Recipient 17, claim 4; g. Recipient 18, claim 4; h. Recipient 20, claim 2; i. Recipient 24, claim 5; j. Recipient 27, claim 7; k. Recipient 27, claim 13; l. Recipient 30, claim 3; m. Recipient 30, claim 4; n. Recipient 30, claim 5; o. Recipient 30, claim 7; p. Recipient 31, claim 4; q. Recipient 31, claim 6; r. Recipient 34, claim 4; and s. Recipient 34, claim 13. In addition, Dr. Crosby also conceded the following claims which had been disallowed by Dr. Hardeman, even though her expert, Dr. Marx disagreed: Recipient 27, claim 6; and Recipient 34, claim 3. To the extent that Dr. Marx agreed with Dr. Hardeman, the undersigned upholds their findings, even if disputed by Dr. Crosby. To the extent that Dr. Crosby conceded claims, the undersigned accepts that testimony, which is supported by that of Dr. Hardeman. Remaining Disputed Claims Eliminating the claims conceded at the final hearing leaves the following claims for determination: Recipient 5, claim 25 (code 41150--denied as error in coding and not a covered service). Recipient 10, claim 3 (code 21215--denied as error in coding, not medically necessary, and not a covered service). Recipient 10, claim 4 (code 21215--denied as error in coding, not medically necessary, and not a covered service). Recipient 11, claim 5 (code 21215--denied as error in coding, not medically necessary, and not a covered service). Recipient 15, claim 10 (code 21215--denied as error in coding, not medically necessary, and not a covered service). Recipient 15, claim 11 (code 21215--denied as error in coding, not medically necessary, and not a covered service). Recipient 16, claim 8 (code 21215--denied as error in coding, not medically necessary, and not a covered service). Recipient 20, claim 1 (denied for lack of documentation). Recipient 21, claim 1 (denied for lack of documentation). Recipient 21, claim 4 (error in coding--payment was reduced, but not denied). Recipient 23, claim 4 (code 21215--denied as error in coding and not a covered service). Recipient 23, claim 5 (code 21215--denied as error in coding and not a covered service). Recipient 24, claim 4 (code 21210--denied as error in coding and not a covered service). Recipient 24, claim 5 (code 21210--denied as error in coding and not a covered service). Recipient 27, claim 8 (code 21215--denied as error in coding, not medically necessary, and not a covered service). Recipient 27, claim 12 (code 21215--denied as error in coding, not medically necessary, and not a covered service). Recipient 29, claim 6 (code 41150--denied as error in coding and not a covered service). Recipient 34, claim 12 (code 21215--denied as error in coding, not medically necessary, and not a covered service). Specific Claims Recipient 5, Claim 25, and Recipient 29, Claim 6 Recipient 5, claim 25, and Recipient 29, claim 6, both concern claims billed for "Reconstruction of a Tongue Fold." AHCA denied these claims based on error in coding and the procedures not being covered by Medicaid. With regard to these claims, Dr. Hardeman testified that Dr. Crosby billed code D41520, which is very specific in its language and requires an incision and rearrangement of tissues. However, the procedure she actually performed was a maxillary frenectomy, which only involves cutting the muscle attachments. Because there was no documentation showing Dr. Crosby made an incision and rearranged the tissues in a Z-plasty formation, Dr. Hardeman opined that code 40806 was more appropriate. Dr. Marx testified that the code used was proper because Dr. Crosby had to place a stitch, even though that code calls for repositioning of tissue, which Dr. Crosby admittedly did not do. The testimony of Dr. Hardeman was more credible than that of Dr. Marx with regard to this issue. AHCA properly adjusted payment for these claims. Recipient 10, Claims 3 and 4 Dr. Crosby coded the procedures as CPC code 21215, grafts in the lower jaw of a 14-year-old patient. However, Dr. Crosby did not "obtain a graft" from this patient. Rather she opened a jar and removed putty to place in the socket after removal of impacted wisdom teeth. Dr. Hardeman testified that a bone graft was not warranted, even for the preservation of the ridge. Younger patients tend to heal better. The current standard of care is not to perform grafting in patients less than 26 years old. Dr. Hardeman relies on the position papers ("white papers") of the American Association of Oral and Maxillofacial Surgeons ("AAOMS"). Dr. Marx disagreed and opined that the 26-year-old cut-off has been disregarded in the last 15 years and that using grafting material leads to complete bone regeneration. According to Dr. Marx, younger patients will get complete healing without grafting material but they will not get complete bone regeneration. Dr. Marx offered no evidence in support of this theory. Dr. Hardeman's testimony regarding the medical necessity of grafting in younger patients is more credible and accepted.2/ Code D7953 is the appropriate code for these procedures, and AHCA properly adjusted payment for these claims. Recipient 11, Claim 5 This claim involves the extraction of tooth 17, an impacted third molar with an enlarged follicle. Both experts agree that grafting was appropriate to preserve tooth 18. However, Dr. Hardeman explained that this was a ridge preservation graft and should have been coded D7953 rather than 21215. Dr. Marx offered no contradictory testimony. AHCA properly adjusted payment for this claim. Recipient 15, Claims 10 and 11 Both claims involve the removal of wisdom teeth from the lower jaw of a 17-year-old. Both experts agree that grafting was appropriate. Again, the dispute centers on the appropriate coding. The experts disagreed regarding the extensiveness of the reconstruction needed. However, because Dr. Crosby did not harvest any graft material from the patient, these procedures were miscoded, and AHCA properly adjusted payment for these claims. Recipient 16, Claim 8 This procedure involved extraction of a molar in the lower jaw and a graft. Dr. Hardeman testified he would not have used a graft for this tooth, but did not explain why. Dr. Marx testified that "if Dr. Crosby had to remove bone to get out the roots and such, then it would be justifiable, but I would have her testify to that, not me." During her testimony, Dr. Crosby agreed with Dr. Marx that this claim should be allowed, but provided no explanation. Insufficient testimony and evidence was provided to decide whether this procedure was medically necessary. However, given the fact that Dr. Crosby did not harvest bone for any of the claims in dispute in this audit, code 21215 is not appropriate, and AHCA properly adjusted payment for this claim. Recipient 20, Claim 1; Recipient 21, Claim 1 AHCA denied claim 1 (limited oral evaluation; problem focused) on Recipients 20 and 21 based on insufficient medical documentation of the evaluation. Dr. Hardeman testified that the necessary components of an evaluation that need to be documented are the medical history, review of symptoms, a review of the data, and an assessment leading to a plan of action. For Recipient 20, claim 1, there was only a notation that the risks were mentioned to the mother. Missing were the chief complaint, a brief medical history of the patient, a review of systems, a review of data (such as X-rays or tests), and a treatment plan. Dr. Marx's explanation, that this amount of information is unnecessary for a limited oral exam, was not credible. For Recipient 21, claim 1, the notes and the treatment provided did not match. The notes reflect Dr. Crosby performed a limited exam for teeth 1, 16, and 32. However, on the treatment date, teeth 31 and 32 were removed. AHCA properly adjusted the payment for these claims. Recipient 21, Claim 4 AHCA reduced payment by $14.00 on claim 4 (tooth root removal) on Recipient 21 based on an error in coding. Dr. Hardeman testified that D7250 was inappropriate and D7210 was appropriate due to the initial status of the tooth. CDT Code 7250 is for the "surgical removal of residual tooth roots (cutting procedure) and "includes cutting of soft tissue and bone, removal of tooth structure, and closure." CDT Code 7210 is for "surgical removal of erupted tooth requiring removal of bone and/or sectioning of tooth, and including elevation of mucoperiosteal flap if indicated," and "includes related cutting of gingiva and bone, removal of tooth structure, minor smoothing of socket bone and closure." Which code applies depends on how much tooth, if any, is present at the beginning of the procedure. If tooth is present above the gum line, the appropriate code is D7210. If only roots remain, the code is D7250. Dr. Marx offered no testimony on this claim. Dr. Crosby explained that she used D7250 because the decay was so extensive that there was virtually no tooth left. However Dr. Hardeman credibly testified that the X-ray taken before the procedure for the tooth showed some tooth remaining. AHCA properly adjusted the payment for this procedure. Recipient 23, Claims 4 and 5 This claim involves the appropriate coding for the removal of two side-by-side molars (teeth 1 and 2) in the upper jaw of a 30-year-old. Dr. Crosby used CPC code 21215 for both procedures. Dr. Marx testified that this coding was appropriate for one tooth but not both. The removal of the two teeth created a jaw defect because the teeth occupied a "fair amount of bone," and was more than a socket defect. However, as with Recipients 10 and 15 discussed above, no harvesting of bone was done. CDT Code 7953 is the appropriate code for the kind of graft used here. AHCA properly adjusted the payment for these procedures. Recipient 24, Claims 4 and 5 These claims involve the removal of teeth 1 and 2 from the upper jaw of a 17-year-old. Both experts agreed that grafting was medically necessary. Dr. Crosby used CPC code 21210. Because there was no harvesting of bone, CDT Code 7953 is the appropriate code for the kind of graft used here. AHCA properly adjusted the payment for these procedures. Recipient 27, Claims 8 and 12 These claims involve the removal of upper and lower left wisdom teeth of a 16-year-old. Dr. Hardeman testified that these procedures were not medically necessary, but did not explain why. However, because there was no harvesting of bone, CDT Code 7953 is the appropriate code for the kind of graft used here, rather than CPC code 21210 and 21215 used by Dr. Crosby. AHCA properly adjusted the payment for these procedures. Recipient 34, Claim 12 This claim involves the lower jaw bone graft in a 12-year-old after removal of tooth 29. Grafting was not appropriate due to the age of the patient. Further, because there was no harvesting of bone, CDT Code 7953 is the appropriate code for the kind of graft used here, rather than CPC code 21215 used by Dr. Crosby. AHCA properly adjusted the payment for this procedure.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency for Health Care Administration enter a final order: requiring Respondent to repay claims in the amount of $841,666.43; imposing a sanction of $49,000.00; and requiring Dr. Crosby to repay AHCA's investigative, legal and expert witness costs. If the parties do not stipulate to the amount of costs, the final order should permit Dr. Crosby to request a hearing to contest the amount of costs. DONE AND ENTERED this 18th day of April, 2019, in Tallahassee, Leon County, Florida. S MARY LI CREASY Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 18th day of April, 2019.
Findings Of Fact The Petitioner premised the prosecution of its case upon certain oral testimony presented in the course of the hearing and certain tangible items of evidence presented in the course of the hearing. The Respondent presented a case in the form of oral testimony, to include testimony by the Respondent, and certain tangible evidence offered in the course of the hearing. The Respondent's presentation was conditioned on the possible rejection by the hearing officer and/or the Florida State Board of Podiatry Examiners, of the Respondent's motion to dismiss or in the alternative motion for more definite statement directed to count (2) of the administrative complaint, and the Respondent's motion which was in the form of a request for directed verdict addressing both counts in the administrative complaint, such motion being made at the close of the Petitioner's presentation. The first witness for the Petitioner was Irma Chanter, who is a dietary supervisor in a local hospital in Palm Beach County. The witness testified that she had been a patient of the Respondent for 3 or 4 years and during that time had received palliative care for her feet. One of the particular areas which was treated by Dr. Perry was the toenails of the patient, Irma Chanter. In connection with that foot problem the witness stated that Dr. Perry indicated that an operation was needed to remove the ingrown toenails and that Dr. Perry suggested that if this operation was not performed the patient would be crippled. The witness was not certain when in time the subject of the operation was discussed with the Respondent; however, it was developed in the course of her testimony that she had bean seeing Dr. Perry since June, 1969. This date was suggested to the witness as being the date of the initial visit to the Respondent and the witness did not take issue with the date. She also indicated that she had checked her income tax records and they showed that she had been Dr. Perry's patient for 4 or 5 years. By way of response to Dr. Perry's suggestion that surgery was necessary, the witness indicated that she wanted time to think about it, and it was also solicited from her that she could not afford such an operation at the beginning of her treatment by the Respondent. The witness did not know if the condition got progressively worse or better during the palliative care stages, but a decision was made by the witness to have an operation performed to remove the toenails and portions of the toenails that were providing problems for her. This operation was eventually performed on July 22 and July 23, 1974, in the office of the Respondent. Mrs. Chanter wasn't particularly satisfied with the Respondent's care, but she said he was never rude, or otherwise objectional before the operation in July of 1974. After that date complaints against the doctor were made, complaints about matters arising in the course of the operation and the post operative treatment, as alleged by the witness in her affidavit attached to the administrative complaint which is Exhibit "A" in that complaint. The witness also seemed to indicate that there were other areas of dissatisfaction. One of the areas was an assertion by the witness that the respondent had over charged for certain X-ray procedures, in that the charge was $250.00 and the witness thought that this was excessive. Additionally the witness complained that the Respondent had charged $75.00 for certain appliances (arch supports) which were allegedly tailored for her purposes and in fact could have been purchased at any retail drug store. The witness brought the above items with her to the hearing and showed them to the hearing examiner. The items were two metal apparatus which appear to be arch supports with the trade name, Dr. Scholls, affixed. In alluding to the complaints which the witness had about the operation, the initial area of consideration is the cost of the operation. The witness seemed to state that she was told the price of certain procedures to be performed was in the amount of $1,275.00 which is the amount stated in her deposition before the hearing. The witness, however, seemed concerned that the Respondent had not indicated the specific cost of the process of the operation which was performed on July 22 and July 23, 1974, as opposed to giving a quotation which would include certain procedures involving bunions and callouses on her feet, as well as the toenail treatment. It was noted later in the course of the hearing, that charges for the procedures effected on July 22 and July 23, 1974, were in the amount of around $580.00, which was in compliance with the insurance rates of Blue Cross Blue Shield's analysis of proper payment by an insurance carrier for such procedures. Of that quoted amount of $580.00, the witness testified that $243.00 was paid by the Blue Cross - Blue Shield and that $219.00 which was tendered under a separate section of the policy was spent by the witness for matters other than payment of the Respondent. In further testimony about the cost of the operation, the witness indicated that she had been unduly put upon about the payment of her bill to the extent of threats directed from the Respondent about her bill. She said she had not paid the bill because she had contracted staph infection following the operation and consequently did not pay anything out of her pocket for the cost of the operation. The operation itself was a radical matricetomy, in which the toenails on the three lesser toes of both feet were completely removed and portions of the toenails of the great toe and the toe adjacent to the great toe were removed from both feet. The process utilized by the Respondent in the operation was a phenol alcohol technique, by the application of carbolic acid. The witness indicated that something was injected into her toes as an anesthetic and that anesthetic was later identified as being xylocaine with epinephrine, 1-200,000. The witness testified that when the toenails were being removed, she said, "it hurt like sam hill when he started digging in." Nevertheless, she never told him to stop the process during the first day's operation * * NOTE: Page 5 is missing from the Original Recommended Order on file with DOAH and is therefore not available in this ACCESS document. any odor at that time. She doesn't know how many days after the operation it was, that she saw the doctor in the office but she does remember going to work the same day she saw Dr. Perry for the visit. She said she made no further follow ups with the Respondent because she contracted staph infection, as diagnosed by Dr. Donald R. Alkema, a local podiatrist. On the Thursday before her initial examination by Dr. Alkema, the witness said that there was a certain excretion which she characterized as being puss, emanating from the area of the feet where the operation had been performed. On Sunday morning the witness notified Dr. Alkema of her problem and the doctor saw her in the office. At the time she went to see Dr. Alkema on Sunday morning there was an excretion from the area where the operation had been performed and her feet were extremely odoriferous, and the odor was nauseating. The witness testified that Dr. Alkema cleaned her feet and prescribed medicine for her. Since that time Dr. Alkema has been her attending physician as it relates to her foot problem. The witness says that she still has pain in her toes and that she can't perform her work as well as before the operation, and that she takes two aspirin for discomfort associated with her present problem. She said that her right large toe in the nail area aches and throbs. Furthermore, she said that on the toe which is immediately adjacent to the left small toe, the toenail has come back and that the right small toenail has come back, when it was her understanding that none of the last three toenails on the toes of her feet would come back. The Petitioner called Dr. Joseph Castronuovo, a specialist in internal medicine. Dr. Castronuovo has been Mrs. Chanter's treating physician and has treated her for high blood pressure and cardiac problems. The cardiac problems mentioned by the doctor were not identified as major problems. The doctor indicated that his contact with Mrs. Chanter around the time of the operations, as performed by the Respondent in July, 1974, was to the extent of seeing the patient on July 29, 1974 after such operation had been performed. This office visit was after being called by Dr. Alkema. At the time of the office visits the blood pressure was 180/102, when the norm in that time sequence had been 140/80. The feet of the patient, Chanter, appeared inflamed but not particularly infected and the witness testified that he did not treat her feet, although Mrs. Chanter had indicated that he did treat the alleged infection. The doctor further stated that he was not aware of the procedure involved in a radical matricetomy, nor was he aware of the normal post operative appearance of a patient's feet. The Petitioner attempted to solicit testimony from the witness to the effect that the failure of the Respondent to notify the witness at a time when the operation was contemplated was unprofessional conduct on the part of the Respondent, because of the patient's high blood pressure and minor cardiac problem. This testimony was objected to and not allowed as acceptable evidence for deliberation by the hearing officer because the hearing officer was of the opinion that the Respondent was not duly noticed of such a claim by the Petitioner to allow the Respondent to adequately defend against it. It should also be noted that the witness indicated that these standards of notification apply to the medical profession of which the witness is a practitioner and not specifically to the canons prescribed for practicing podiatrists. One comment was made by the witness that he felt that application of anesthetic which had as a part the substance known as ephinephrine was not advisable in the case of Mrs. Chanter. However, later testimony by the Respondent indicated that the percentage of ephinephrine in the xylocaine applied to the patient was one half the normal strength. Further, development of the testimony offered by the doctor concerning the question of the alleged unprofessional conduct for failing to notify the witness of the proposed operation will be developed in the section of this Recommended Order entitled CONCLUSIONS OF LAW. The Petitioner next tried to produce testimony through a witness Ayn Dupay. Ayn Dupay had been a patient of Dr. Perry in the Spring of 1974, and had had heavy callouses and ingrown toenails. Additionally, she was operated on by the Respondent in July, 1974. This witness' testimony was objected to since it was the contention of the Respondent, that the Respondent had not been duly apprised of any allegations pertaining to this witness, notwithstanding the fact that the Petitioner had subpoened the records of this patient to be produced at the hearing. This objection by the Respondent was sustained because the requirement for notice was felt to be lacking as it relates to testimony by Ayn Dupay and because there appeared to be no other basis for allowing that testimony. A more complete examination of the objections and the reasons for sustaining the objections will be addressed in the section of this Recommended Order entitled CONCLUSIONS OF LAW. Nathan Johnson, a representative of Blue Cross - Blue Shield was called to the stand. He had with him a report rendered by G. M. Perry about the patient, Irma Chanter. This report referred to the procedures which were performed on Mrs. Chanter as being a radical matricetomy. The witness further identified himself as a person who has had a long standing association with people in the field of podiatry, as it relates to the processing of certain insurance claims in this field. Moreover, the witness though not a medical practitioner, has studied the literature on the procedures in the field of podiatry. Based upon the witness' ability and expertise in the field of insurance, the Petitioner tried to establish the witness' opinion on whether or not the toenail should have come back on toes where a total matricetomy had been performed. This testimony was objected to by the Respondent and the objection was sustained on the question of the witness' expertise to determine the reasonable result of a total radical matricetomy. A more complete discussion of the objection and ruling will be considered in the section of this Recommended Order entitled CONCLUSIONS OF LAW. Rosemary Colvin, Director of Medical Records, Palm Beach Gardens Hospital, Palm Beach Gardens, Florida, was called to the stand. She produced the records of the patient identified as Albert Frankel, deceased. This patient had been admitted in the Palm Beach Gardens Hospital in the past. Albert Frankel had been a patient of the Respondent, and the purpose of introducing the facts pertaining to Albert Frankel was identified by the Petitioner's counsel as a showing of impropriety on the part of the Respondent pertaining to matters about Albert Frankel. This testimony was objected to because of the lack of notice to defend against matters pertaining to Albert Frankel. Because of such problems with the notice and an insufficient showing of any other reason to justify the introduction of such evidence, the evidence was deemed improper for consideration by the hearing officer in the deliberation of the matters in this case. A more complete discussion of the reasons will be set forth in the section of this Recommended Order entitled CONCLUSIONS OF LAW. Dr. Donald Alkema took the stand. Dr. Alkema is a practicing podiatrist who has been in the profession for five years and is licensed in the State of Florida to practice. A stipulation was entered into concerning the expertise of the witness to testify about matters relating to the treatment of Irma Chanter's foot problems. The witness testified that he first saw Irma Chanter on July 28, 1974, at which time he debrided certain necrotic tissue associated with the operation performed by Dr. Perry, and that he drained the puss and applied a cleansing agent. The witness provided certain slides of photographs taken of the condition, the first two slides showing the right and left foot on Sunday morning, July 28, 1974, was depicting, according to the witness, infection and an abscess on the left great toe. Slides three and four were taken on August 1, 1974, which the witness indicated showed an improvement because of an antibiotic which had been prescribed. Slides five and six were taken August 19, 1974, which showed further improvement of the condition. The witness testified that in his opinion the procedure which had been utilized in the treatment of Irma Chanter was a phenol technique involving carbolic acid, which is an application of that substance to the matrix of the nail. The witness further stated that the procedure involved was a total matricetomy of the three smallest nails of the left and right foot, and a partial matricetomy of the remaining toenails on both feet. The diagnosis by Dr. Alkema of the infection was acute infection of the left foot, first and second toes; and right foot, first and third toes, with the remainder of the toes showing subacute infection. The appearance of Mrs. Chanter's feet at the time of examination revealed that the feet were clean in terms of the overall condition; however, there was a certain purulent discharge with associated odor, which the witness deemed to be some form of staphylococcus bacteria. Based upon the visual observation of the patient and the fact that the witness' mind time was of the essence, the witness said that he did not request laboratory analysis of the excretion from Mrs. Chanter's feet, in the way of a culture workup, but prescribed a broad spectrum antibiotic known as tetracycline hydrochloride. The witness felt that the antibiotic, as prescribed helped to defeat the infection. At present Mrs. Chanter is still under the treatment of Dr. Alkema and the patient still has problems with ingrown toenails. To the witness' recollection, Mrs. Chanter still has some pain associated with the great toe of the left foot and the fifth toe of the right foot, but not with the great toe of the right foot, as testified by Mrs. Chanter. In discussing the technique utilized by Dr. Perry in performing the operation on Mrs. Chanter, the witness testified that he does not utilize the process, but uses another process called SNT-1 which is a method of extraction by surgical instrument. His direct knowledge of the phenol process is to the extent of involvement four times as a student and two dozen observations. Nevertheless, the witness testified that in his estimation the phenol technique was relatively simple, although he agreed that that technique would be more effective if the practitioner had done it more. The witness said that he was unable to comment on the effectiveness of the operation since he was not in attendance at that operation. In response to questions about the outcome of the operation, the witness stated that Mrs. Chanter came to him and was complaining of pain in her toes radiating into her foot, and as related before, that in his estimation there was infection present in all ten toes. Based upon this observation, it was felt by the witness that the prescription of aspirin for treatment of the pain was insufficient. In support of this position the witness indicated that xylocaine is a prescribed anesthetic for the phenol technique and that when the effects of the xylocaine wear off that 10 percent of the patients experience pain and 1 to 2 percent experience excruciating pain, and that percentage may rise according to the number of toes involved in the operation. These statistics were based upon a certain medical text referred to by the witness, which was not authored by the witness. In the witness' opinion there is a certain risk of infection in any surgery and he agreed that the staphylococcus infection is common in many places to include the soil. In discussing the history of the situation with Mr. Chanter on July 29, 1974, the witness indicated the history only involved the history of the surgery and not the history of the patient's activities following the surgery. Although the witness felt that discussion of the technique involved in the performance of the phenol process was better stated by a person who had administered this technique on more numerous occasions, the witness felt that he was qualified, certainly as qualified as the practitioner utilizing the phenol technique in discussing the post operative procedures. In the witness' mind the post operative techniques employed by the Respondent were not acceptable in that, to his knowledge, the Respondent had prescribed the use of garamycin antibiotic ointment and this ointment was felt to be improper because it tended to cap the infection. The witness indicated that he has an office that is located essentially 100 yards away from the office of the Respondent, but that the Respondent and he are in no respect in competition for business, and the witness expressed his resentment to the characterization of his profession in those terms. In a related area an effort was made by the Petitioner's counsel to introduce through the witness, certain matters pertaining to surgery performed on Albert Frankel and Ayn Dupay, who have been previously mentioned in the course of the Findings of Facts, and this testimony was objected to based upon the lack of notice of such claims against the Respondent. The objection was sustained and will be more fully addressed in the section of this Recommended Order entitled CONCLUSIONS OF LAW. Finally, the witness indicated that the podiatrist's ethics call for consulting a treating physician who is a medical doctor when appropriate since the podiatrist may only treat a situation for which he has expertise, and the witness seemed to indicate that this should have been done by the Respondent in treating Mrs. Chanter. Furthermore, the witness did notify Dr. Castronuovo of the condition which he observed upon examining Mrs. Chanter on July 28, 1974. Dr. James Vance, who is a specialist in internal medicine, was called to the stand. Dr. Vance indicated the treatment of Albert Frankel, deceased, while in the Palm Beach Gardens Hospital. The witness indicated that there were some entries on the chart of Albert Frankel which he did not make, nor the urological service that was treating the patient and that were later discovered to have been made by the Respondent, who was not authorized to practice in the Palm Beach Gardens Hospital. An objection was made to the offering of such testimony on the basis of lack of notice on the part of the Respondent to contentions of this sort, concerning the treatment of Albert Frankel and that objection was sustained. A more complete examination of the objection will be considered in the section of this Recommended Order entitled CONCLUSIONS OF LAW. Dr. Vance was the last witness on behalf of the Petitioner and at the close of the Petitioner's case a motion for directed verdict was made by the Respondent, in that the Respondent contended that insufficient proof had been established to show violations of either Count 1 or 2 of the Administrative Complaint, whether the standard be one of preponderance of evidence or a standard of clear and convincing evidence. Ruling on that motion was reserved until such time as the facts in this matter were considered by way of deliberation and the Respondent elected to present a case based upon the hearing officer's desire to reserve ruling and upon the possibility that the Petitioner would overturn a decision adverse to its position when it examined the Recommended Order entered by Hearing Officer. After hearing the testimony offered by the Petitioner, the Motion for Directed Verdict against Count 2 of the Administrative Complaint would seem well taken, for reasons more completely discussed in the section of this Recommended Order entitled CONCLUSIONS OF LAW. The Respondent, in the presentation of its case first called Dr. Arthur Binkowitz, D.P.N. Dr. Binkowitz has been a podiatrist for five years and it was stipulated to between the parties that the witness was qualified to give testimony in the area of podiatry. The witness testified that a matricetomy is an excision at the matrix cells which produce nail plates. The witness also testified that the method he utilizes to accomplish this is the phenol technique and that he utilizes that technique 99 percent of the time. These excisions are accomplished under local anesthesia. In addressing the terms total or partial matricetomy the witness said that these procedures are the same in that they are both radical procedures, one designed to excise the total nail and the other designed to excise part of the nail. The witness said he has done hundreds of these excisions under the phenol technique, and that this technique is not a learning situation. The witness was shown the slides as produced by Dr. Alkema in his testimony, and stated that this is the first viewing of those slides by the witness. After establishing the underlying facts by way of a hypothetical depiction of the slides, the witness offered testimony. Looking at slides 1 and 2 he felt that the depiction was normal and that inflammation present was as in phenol operations but that there was no indication of infection. In looking at the slides, he said he did not see any unusual redness. He said the item in number 2 which had been described as an abscess by Dr. Alkema, in his mind was a condition caused by a drop phenol, perhaps. Slides 3 and 4 looked normal to him, with slight inflammation and the alleged abscess as shown on 4 looked like a phenol burn. Slides 5 and 6 looked normal to him. Describing the pain associated with the process he felt that the process was relatively painless and that he usually prescribes aspirin for his patients. He said that he feels that garamycin, the antibiotic, or HCB cream among others are acceptable antibiotics to utilize in the post operative treatment where the phenol process had been utilized. He also indicated that utilization of the phenol technique is a technique in which infection is less likely. When shown the appliances which were brought by Mrs. Chanter he said that these appliances might have been utilized but they don't do anything to assist, and that they are not normally prescribed. Furthermore, these appliances could be bought at any drug store. Finally he indicated to prescribe such appliances would be a disservice to the patient. The witness indicated that he is a friend of Dr. Perry, but indicated that he could be objective. Under questioning about the regrowth of a nail which had been totally excised by a radical matricetomy, he felt that this nail should not return but that because of certain permeability problems associated with certain patients that the procedure is not always 100 percent effective and that this effectiveness percentage cannot be predetermined. He further elaborated on the use of analgesic, stating that he prescribed a heavier analgesic as necessary. The post operative condition of the normal patient according to the witness was one that would allow the patient to stand on their feet as long as they continued to apply soaks. In addressing the high blood pressure problem associated with Mrs. Chanter he said that this was not of itself sufficient in his mind to consult a medical doctor before operating. In the matter related to the pain associated with the process of the operation he indicated that the pain is relatively free after the phenol compound goes to work in the prescribed area. When shown the patient's feet in the course of the hearing he felt that the process was most likely a phenol technique that the first two toes on both feet including the largest toe were partial matricetomies and that the third, fourth, and fifth toes of both feet were total matricetomies and that there appeared to be no problem with the outcome of the operation. Under examination of the hearing officer the witness felt that the improvement shown in slides 3, 4, 5, and 6 was not due to the application of the antibiotic tetracycline hydrochloride. He also stated to the hearing officer's questions, that there is a certain odor associated with the post operative condition when the phenol process is used. The Respondent next called Dr. Bruce Neal Kramer, D.P.N., licensed since 1967 and licensed in the State of Florida since 1971. A stipulation was entered into concerning this witness' ability to offer testimony in the field of podiatry. Dr. Kramer testified much in the same way as Dr. Binkowitz with several additional observations. One of the observations was to the effect that the appearance of Mrs. Chanter's feet upon his examination during the course of the hearing showed a growth on the lesser toe of the left foot which could have been a callous or possibly a regrowth of a toenail. He also indicated that if there was odor associated with the feet that the odor could mean some infection, but not staphlococcus infection. Finally the doctor indicated that if there was some purulent discharge associated with the post operative condition of the feet, that he would have ordered a culture (laboratory culture) made of the substance to determine the nature of the bacteria. The witness' overall description of the slides, prepared by Dr. Alkema, was to the effect that the condition was a normal post operative appearance. The Respondent took the stand and testified that he had been licensed to practice podiatry in the State of Florida. He first saw the patient Irma Chanter on June 27, 1969 and treated her for callouses, bunions, corns and ingrown toenails. The initial treatment was palliative in nature, but from the beginning he recommended more than palliative care after viewing the x-rays which showed a problem, that in his mind could be alleviated by operations. The charge for those x rays was $20.00. The Respondent indicated that Mrs. Chanter did not want the surgery performed because she could not afford it and he continued to treat her on a monthly basis and to remove the corners of the toenails that were presenting problems. In response to the appliances which were produced by Mrs. Chanter, the witness stated that these appliances were not in fact the appliances that he had prescribed for her. He had prescribed a leather device because metal was not the technique used on adult patients. Moreover, he indicated that the metal apparatus had been shown to him on the initial visit. The charge for the appliances prescribed by the witness was $75.00 for examination, molding and the device itself. The witness recommended the phenol technique for the problem that Mrs. Chanter was having with her ingrown toenails and also some surgical procedure to be applied for the bunion problem. He quoted a fee for hospital work to include the bunions, toenails and other procedures. The fee quoted was $1,125.00 for all work. He explained all surgery, to include the surgery for removing the toenails which was performed on July 22 and July 23, 1974. The reasons for splitting the days of the surgery was as an accommodation for Mrs. Chanter because of her nervousness about the operation. At the end of the first day's operation on July 22, 1974, he sent Mrs. Chanter back to work without a day off for the procedures. In describing the technique employed in the removal of the toenails he indicated the preparation of scrubbing of the patient's feet and the application of the phenol until the tissue turned gray and then he flushed the surface with alcohol. There was no indication of pain by the patient except on the injection of the xylocaine, although his office assistant did hold Mrs. Chanter's hand because of her nervousness. He prescribed nothing for pain except to say to take an aspirin but he told the patient to call if she experienced any pain. There was no call or complaints the night of the 22nd, nor any complaints on the 23rd of July, at which time the procedure was completed. On the second day of the surgical procedure, again Mrs. Chanter was nervous and the office assistant held her hand, although there was no pain beyond the moment of the injection of the xylocaine. The instructions given to the patient at the close of both days was to soak the feet in domboro solution; to apply garamycin cream; and to bandage the toes with a particular bandaid which was shown to the patient, Mrs. Chanter. Mrs. Chanter was also provided with a list of instructions which is similar to Respondent's Exhibit 1 (that Exhibit being a part of the record) When the patient came back to the doctor's office on July 25th, she had the wrong bandaids and plastic wedge closed shoes, and her feet were not clean. The doctor made corrections in these matters and noted that although there was a dirty appearance of the feet, that there was not any infection. After leaving on the 25th the patient called the doctor's office and said that she would not be coming back and in response to the efforts of the Respondent to contact Mrs. Chanter by phone, the phone was hung up by Mrs. Chanter. The doctor feels that the reason for the disagreement concerned a fee dispute in which he had indicated that he would be willing to work with her on some basis to pay for the operation but his office personnel had asked for some token payment and Mrs. Chanter had become offended by this matter. The doctor said he saw Mrs. Chanter's feet at the time of her deposition in this matter which was October 9, 1975, and again at the hearing, and felt that the appearance of the feet was acceptable. He knew of the high blood pressure condition but did not contact Dr. Castronuovo because he felt that the condition was within his ability to control. In that pursuit he used the xylocaine with 1/200,000 parts epinephrine, as opposed to the normal 1/100,000 parts epinephrine. An effort was attempted on the part of the counsel for the Petitioner to consider the matters involving Albert Frankel and Ayn Dupay in certain law suits in the interest of those parties. These attempts were objected to and the objection was sustained on the basis that the Respondent was not duly noticed of these potential allegations prior to the hearing. A more complete description of the reason for disallowing that testimony will be set forth in the section entitled CONCLUSIONS OF LAW. Based upon the facts as presented in the course of the testimony at the hearing, the hearing officer is convinced that the Respondent did not overcharge Mrs. Chanter for the performance of the operation. The infection, if any, was not caused by any procedures involved with the operation or post operative treatment afforded by the Respondent. It is established that as of July 25, 1974, according to the Respondent and Mrs. Chanter, the infection was not present. It has also been established that the opportunity existed for infection to set in beyond the control of the Respondent and Mrs. Chanter removed herself from the Respondent's treatment after July 25, 1974, such that he would not have been aware if such infection had set in. Dr. Alkema testified that in his opinion, infection was present on July 28, 1974, but his analysis was not followed up by any laboratory confirmation and was contradicted by Dr. Binkowitz and Dr. Kramer. The contradiction by the latter was on the basis of their statement that a visual observation of the purulent discharge would not, and in their estimation could not, label the infection as staphylococcus. Moreover, the only reasonable way they felt to effect an identification was by laboratory analysis. Again such a staphylococcus infection according to Dr. Kramer was not best treated by tetracycline hydrochloride. Dr. Binkowitz and Dr. Kramer also felt that from the examination of the slides as prepared by Dr. Alkema, that infection probably was not present and that the appearance of the slides indicated a normal recovery for the phenol process, a process that they were more familiar with than Dr. Alkema. In considering the possible contention that the operation was not successful as it relates to the lesser toe of the left foot, there is some dispute as to whether or not the recurrence is one of a toenail or some callous, which appears in the area of the toenail. Nevertheless, assuming that the substance is a toenail, accepting the statement of Dr. Binkowitz as to the possibility that a toenail will reappear even with the best efforts of the physician, because of a problem with permeability of a patient's toe, it would not appear that the operation was unsuccessful because of any willful negligence or incompetence on the part of the Respondent, nor any unprofessional conduct in performing the treatment. The contention was made that the Respondent was unprofessional in failing to notify Dr. Castronuovo of the impending operation on Mrs. Chanter, knowing that Mrs. Chanter was a patient of Dr. Castronuovo. Accepting the fact that Mrs. Chanter was a patient of Dr. Castronuovo, and keeping in mind the ruling that the Respondent was not duly noticed of such a charge of unprofessional conduct, nevertheless, it would appear that under the circumstances of the testimony set forth In the course of the Findings of Fact, it was not unprofessional on the part of the Respondent to fail to notify Dr. Castronuovo. It was suggested in the course of the hearing that there was a failure on the part of the Respondent to prescribe adequate analgesic for pain. From the testimony offered by doctors Perry, Binkowitz and Kramer, it would appear that the prescription of aspirin as a beginning analgesic was appropriate and the Respondent did not act in a willfully negligent or incompetent manner or unprofessional manner in failing to prescribe any stronger analgesic. Dr. Alkema's testimony on the question of the proper analgesic did not seem to contradict this position, in that he only suggested that he would prescribe a stronger analgesic if the condition warranted, and in this instance Mrs. Chanter did not sufficiently indicate to the Respondent that she desired a stronger analgesic. It was also brought out in the course of the hearing that the Respondent utilized the wrong anesthetic, in prescribing xylocaine with epinephrine. However, he did utilize a solution in which the epinephrine had been reduced and the testimony did not show any ill effects from the use of any anesthetic which had as a part of the solution the substance epinephrine.
Recommendation It is therefore recommended that the Respondent, Gerson M. Perry, be released from all charges brought under this Administrative Complaint. DONE and ENTERED this 28th day of January, 1976, In Tallahassee, Florida. CHARLES C. ADAMS Hearing Officer Division of Administrative Hearings The Carlton Building 2009 Apalachee Parkway Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Lawrence M. Kukey, Esquire 507 North Olive Avenue P. O. Box 3466 West Palm Beach, Florida, 33402 John S. Miller, Jr., Esquire P. O. Box 10137 Tallahassee, Florida 32301 For the Board
