Findings Of Fact On February 16, 1977, Joe Hodges, an inspector in petitioner's employ, inspected respondent's premises in the normal course of his duties. On a form styled "Public Food Service Inspection Record," Mr. Hodges noted that respondent's refrigerators lacked thermometers; that the dishwasher needed a new temperature gauge; that a screen door opening onto the outside from the kitchen was not in good repair; that the employees' restroom had no soap and towels and had a window screen in need of repair; that the surfaces of some work tables were not smooth; that the employees' hair restraints were ineffective; and that there were many roaches. After this inspection, respondent Laramore acquired thermometers for the refrigerators, caused the area outside the premises to be cleaned, put soap and towels in the employees' restroom and caused the restroom window screen to be repaired. On March 22, 1977, Mr. Hodges returned to respondent's premises, inspected again and issued a formal directive to respondent to exterminate roaches, clean the kitchen floors, repair certain nozzles on the dishwasher, clean certain equipment, store food elsewhere than on the floor of the walk-in refrigerator, lower the temperature in certain refrigerators, provide additional refrigerator thermometers, repair the lining of a freezer lid, and furnish effective hair restraints to employees. On the following day, respondent contacted Larry Farris of Panhandle Pest Control, who regularly sprayed the restaurant for bugs, and asked him to take whatever extra steps were necessary to exterminate the roaches. On the same day, respondent contacted Easom Plumbing Company and arranged for the dishwasher to be repaired. The screen door was fixed, although it was broken subsequently by men using dollies to deliver supplies. Respondent caused the freezer lining to be replaced, certain table tops to be sanded down, a sink drain to be repaired, and the entire kitchen to be steam cleaned. On March 21, 1977, Mr. Hodges returned to respondent's premises and filled out a call back inspection report which listed the items set forth in the notice to show cause, petitioner's exhibit No. 1. On December 30, 1977, together with Mr. George Parish, Mr. Hodges made another visit to respondent's premises. Mr. Parish and Mr. Hodges found roaches, a torn screen on the back door, dirty equipment and a refrigerator containing salad and pastries stored at a temperature of 56-60 degrees. Mr. Parish saw live German cockroaches in many places, notably near an oven no longer used for cooking. This oven, certain other equipment, aswell as dish and pot storage shelves were dirty and needed to be cleaned. Mr. Parish noticed roach excrement caked alongside one of the tables in the kitchen. Mr. Parish and Mr. Hodges found that the sink drain leak had been fixed. They perceived no deficiency in respondent's employees' hair restraints, even though these did not differ significantly from restraints used in the spring of 1977. They also found that respondent's dishwasher had been repaired. At the time of the inspection on December 30, 1977, the dishwasher operator, who was washing one load after another, made a wash cycle last two and a half minutes and followed up with a rinse cycle lasting a minute and a half. The dishwasher contained a hot water heater to boost the temperature of the water used for washing and rinsing dishes in the machine. Although this was in good working order, the dishwasher was being operated with a rinse water temperature of only 172 degrees. The normal wash cycle is 30 seconds and the rinse cycle normally lasts only 12 seconds. With repeated loads of dishes and abnormally long cycles, the water used for dishes in later loads does not reach the same high temperature as at first.
Recommendation Upon consideration of the foregoing, it is RECOMMENDED: That petitioner assess a civil penalty against respondent in the amount of one hundred dollars ($100.00). DONE and ENTERED this 31st day of January 1978, in Tallahassee, Florida. ROBERT T. BENTON, II Hearing Officer Division of Administrative Hearings Room 530, Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: Mr. Lawrence D. Winson, Esquire The Johns Building 725 South Bronough Street Tallahassee, Florida 32304 Mr. Herman D. Laramore, Esquire Post Office Box 793, Courthouse Marianna, Florida 32446
Findings Of Fact Chanticleer Apartments contain 38 units and have been issued license number 23-2425H by the Division of Hotels and Restaurants. An inspector from Petitioner's Miami office, in response to complaints from tenants, inspected the Chanticleer Apartments on July 14, 1978, immediately following a heavy rainfall. It was noted that the air conditioner over the door of apartment No. 27 was dripping onto the sidewalk below. It was also noted that refrigerators in apartments No. 3 and No. 28 were dripping. When queried from whence the drip was coming, the inspector did not know or remember. Nor did he know if the refrigerator was dripping because it needed defrosting. Outside steps had recently been painted with enamel paint which was slippery when wet. Following the heavy rain that had recently fallen, there were puddles on the sidewalk in one or two places and a puddle on the paved area between the parking lot and the apartments. Testifying on behalf of Respondent, the manager of the apartments stated that a defective refrigerator in apartment No. 3 had been replaced when she was advised it was bad but that older refrigerators were not frost free and unless the tenants defrosted them, ice formed around the coils would melt and drip. Between the time of the inspection and this hearing, the error perpetrated by the enamel paint on the steps had been corrected with a non-skid paint applied to the steps. With respect to the puddling of water, this witness stated an additional baffle had been installed on the roof to divert water away from the paved areas. She also stated that a project had been underway for some time to replace all drains on wall-mounted air conditioners and this project was continuing.
The Issue The issue presented is whether Respondent Seanic Corporation's application for an operating permit for a domestic wastewater treatment facility should be granted.
Findings Of Fact On January 20, 1994, Respondent Seanic Corporation submitted to Respondent Department of Environmental Protection an application to construct a wastewater treatment and disposal facility. The application requested approval to construct a facility with a design capacity of 15,000 gallons per day and to discharge its treated effluent to G-III groundwater through two Class V injection wells. Although the Department had no rules with specific depth requirements for such wells, the plans that accompanied the application contemplated wells with a total depth of 90 feet below land surface, which would be cased down to a depth of 60 feet below land surface. On February 23, 1994, the Department gave notice of its intent to issue the requested construction permit. Petitioners did not challenge the issuance of the construction permit, and the Department issued the permit on April 22, 1994, with an expiration date of five years after the issuance of the permit. On February 17, 1999, Seanic began construction of the permitted facility, including the construction of the two Class V injection wells. At the time the wells were first drilled, there were no statutes or rules regarding the appropriate depth of underground injection wells at a facility like Seanic's. Construction of the Seanic facility was completed before April 12, 1999, as reflected by the Certificate of Completion of Construction for the permitted facility. On April 21, 1999, Seanic filed with the Department its application to operate the facility. Chapter 99-395, Laws of Florida, became effective on June 18, 1999, approximately two months after the facility was constructed and the operating permit application was submitted. Section 5 of Chapter 99-395 defines the term "existing" to mean "permitted by the Department of Environmental Protection or the Department of Health as of the effective date of this act." Chapter 99-395 imposes different effluent limitations for "existing sewage facilities" than those that are applied to new facilities. For facilities that have a design capacity of less than 100,000 gallons per day, new facilities must provide treatment that will produce an effluent that contains no more, on a permitted annual basis, than the following concentrations: Biochemical Oxygen Demand (CBOD5) of 10 mg/L Suspended Solids of 10 mg/L Total Nitrogen of 10 mg/L Total Phosphorus of 1 mg/L These standards are frequently referred to as the "10-10-10-1 Standard." In accordance with Section 6(4) of Chapter 99-395, "existing sewage facilities" have until July 1, 2010, to comply with the 10-10-10-1 standard. Prior to that date, "existing sewage facilities" must meet effluent limitations of 20 mg/L for both CBOD5 and suspended solids and must monitor their effluent for concentrations of total nitrogen and total phosphorus. The Seanic facility is an "existing" facility, as that term is defined in Chapter 99-395, and, therefore, has until July 1, 2010, to comply with the 10-10-10-1 standard. Section 6(7)(a) of Chapter 99-395 requires Class V injection wells for facilities like Seanic's to be "at least 90 feet deep and cased to a minimum depth of 60 feet or to such greater cased depth and total well depth as may be required by Department of Environmental Protection rule." The Department has not promulgated any rules requiring Class V injection wells to be deeper than the depth prescribed in Chapter 99-395, Laws of Florida. As of January 26, 2000, the total depth of Seanic's injection wells measured 92 and 94.5 feet, respectively. On November 24, 1999, the Department entered its notice of intent to issue the operating permit applied for by Seanic and attached to the notice a "draft permit" with the conditions and effluent limitations that would be applied to the facility. In issuing the notice, the Department determined that Seanic had provided reasonable assurance that the facility will not discharge, emit, or cause pollution in contravention of applicable statutes or the Department's standards or rules. The draft permit included effluent limitations of 20 mg/L for both CBOD5 and suspended solids and required Seanic to monitor its effluent for total nitrogen and total phosphorus, in accordance with Chapter 99-395, Laws of Florida, and the Department's rules for existing sewage facilities. The draft permit notes that Seanic must comply with the 10-10-10-1 standard by July 1, 2010. Because Seanic's condominium development has not been completed and the wastewater treatment facility is not expected to go into operation for approximately one year, the draft permit also requires that the facility be re-inspected and re-certified immediately prior to going into operation. The Seanic facility was designed to create an effluent that is several times cleaner than required by Department rules. The facility uses an extended aeration process that is expected to reduce levels of both biological oxygen demand ("BOD") and total suspended solids ("TSS") to lower than 5 mg/L, concentrations that are 75 percent lower than the effluent limitations in the draft permit. Similar facilities in the Florida Keys have shown that they can achieve BOD and TSS concentrations of less than 5 mg/L. The Seanic facility has also been designed to provide a greater level of disinfection than required by law. While the draft permit requires only that the facility maintain a chlorine residual of 0.5 mg/L after fifteen minutes' contact time, the facility has been designed with larger chlorine contact tanks to provide a chlorine contact time of approximately one hour at anticipated flow rates. The facility operator can also increase residual chlorine concentrations. These facts, along with the reduced TSS levels at this facility, will provide considerably greater levels of disinfection than the law requires. Although the draft permit does not contain effluent limitations for total nitrogen or total phosphorus, the levels of these nutrients expected to be present in the Seanic facility's effluent are approximately 5 mg/L and 2-3 mg/L, respectively. Studies conducted on the rate of movement of phosphorus in the subsurface indicate that some of the phosphorus is rapidly immobilized through chemical reactions with the subsurface soil matrix. Specifically, studies conducted on injection wells in the Florida Keys report that 95 percent of the phosphorus is immobilized within a short time after entering the injection well. Studies conducted on the rate of movement of nitrates in the subsurface indicate that some nitrate migration is also retarded through chemical reactions with the subsurface soil matrix. More specifically, studies conducted with injection wells in the Florida Keys report that denitrification removes approximately 65 percent of the nitrates within a short time after the effluent enters the injection well. In addition to the chemical reduction of phosphorus and nitrogen levels in the groundwater, studies conducted on injection wells in the Florida Keys with a total depth of 90 feet and a cased depth of 60 feet have reported extremely high dilution rates by the time effluent injected into such wells would appear in surrounding surface waters. More specifically, studies using chemical and radioactive tracers have reported dilution rates on the range of seven orders of magnitude, i.e., 10 million times. After undergoing chemical reduction in the groundwater as well as extremely high dilution rates, the levels of nitrogen and phosphorus that would be expected to enter Captain's Cove and the adjacent canals will be infinitesimal, i.e., less than one part per trillion. Such levels would be several orders of magnitude below detection limits of currently available analytical methods. The surface waters in the artificial canals and in Captain's Cove surrounding the homes of Petitioners' members are classified by the Department as Class III waters that are predominantly marine. The permitted levels of fecal coliform bacteria in the facility's effluent (as restricted in the draft permit) are identical to the discharge limits for fecal coliform bacteria in Class III waters that are predominantly marine. The operation of Seanic's facility will not result in discharges of fecal coliform bacteria in excess of the applicable effluent limitations. Petitioners' expert witnesses agree that the facility, as designed, will comply with all of the conditions and effluent limitations in the draft permit. No Department rule or standard will be violated by this facility. The Department has not promulgated any effluent limitations or standards for viruses to be discharged to G-III groundwater or Class III surface waters that are predominantly marine. Petitioners' members use and enjoy the clear waters in their canals and in Captain's Cove. They have had the water quality tested four times a year since 1988. Captain's Cove, along with the adjacent canals, has remained a clear, oligotrophic water body with minimal algae growth. Petitioners' members fear that the introduction of viruses and other microorganisms through the facility's effluent will cause swimming in Captain's Cove and the adjacent canals to be harmful to their health. Their fear has been heightened by newspaper stories about viruses and a publicized study which erroneously claimed that Captain's Cove had high levels of harmful bacteria. Petitioner Port Antigua Property Owners Association ("PAPOA") received notice of the Department's intent to issue an operating permit to Seanic. The president discussed the permit with another resident, a microbiologist, who in turn discussed the facility with geologists and reviewed studies performed in the Florida Keys. Their serious concern over the depth of the injection wells and the possible release of viruses and bacteria harmful to the marine environment and to the public health was expressed throughout PAPOA's petition, and a copy of one of the tracer studies upon which they relied was attached to the petition. The president of Petitioner Port Antigua Townhouse Association, Inc. ("PATA"), who is also a member of PAPOA, discussed the Department's notice of intent with the president of PAPOA and the microbiologist. He also discussed the project with a member of PATA who oversees Broward County's wastewater treatment facility, which has the same effluent limitations as the Seanic facility. PATA members believed they should join with PAPOA and the Lower Matecumbe Key Association in requesting a hearing on Seanic's operating permit. PATA and others have also filed litigation in the Circuit Court against Seanic Corporation and others. That litigation is still pending. Petitioners were not able to cite any statute or rule that would be violated by the Seanic facility's discharge. They believe that since the facility is not yet operating, it should be required to adhere to the stricter effluent standards required for new facilities. They also believe that the Department should consider the harmful effects of viruses and bacteria on the marine environment and on the public health. Petitioners did not file their petitions for any improper purpose. They did not file their petitions for any frivolous purpose or to harass or to cause unnecessary delay or to increase Seanic's costs in obtaining an operating permit for its facility. They believed the language in the Department's notice of intent to issue the permit which advises substantially affected persons that they have a right to an administrative hearing and that the Department could change its preliminary agency action as an result of the administrative hearing process. They believe they are simply exercising a right that they have under the law.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered granting Seanic's application for an operating permit for its domestic wastewater treatment facility but denying Seanic's Motion for Attorney's Fees and Costs. DONE AND ENTERED this 13th day of November, 2000, in Tallahassee, Leon County, Florida. LINDA M. RIGOT 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 the Clerk of the Division of Administrative Hearings this 13th day of November, 2000. COPIES FURNISHED: Francine Ffolkes, Esquire Department of Environmental Protection 3900 Commonwealth Boulevard Mail Station 35 Tallahassee, Florida 32399-3000 Evan Goldenberg, Esquire White & Case, LLP First Union Financial Center 200 South Biscayne Boulevard Miami, Florida 33131-5309 Lee R. Rohe, Esquire Post Office Box 500252 Marathon, Florida 33050 Kathy C. Carter, Agency Clerk Department of Environmental Protection 3900 Commonwealth Boulevard Mail Station 35 Tallahassee, Florida 32399-0300 Teri L. Donaldson, General Counsel Department of Environmental Protection 3900 Commonwealth Boulevard Mail Station 35 Tallahassee, Florida 32399-0300
The Issue The issues presented are (1) whether the Subscriber Assistance Panel had jurisdiction to hear the Subscriber's appeal; (2) whether this matter is properly before the Division of Administrative Hearings; and (3) whether the cold water therapy device utilized by the Subscriber is covered under the subject Humana commercial policy.
Findings Of Fact Petitioner Humana Medical Plan, Inc., is a health maintenance organization (hereinafter "Humana" or "HMO") authorized to operate in Florida pursuant to a certificate of authority issued in accordance with Part I of Chapter 641, Florida Statutes. The affected agency in this proceeding is the Office of Insurance Regulation (hereinafter "Office"). Humana issued a large group contract providing health insurance coverage to the School District of Hillsborough County for the benefit of the School District's employees and their eligible dependents. During all times relevant to this proceeding, the Subscriber T. O. was enrolled in this HMO Plan. The Office had previously reviewed and approved the terms of Humana's Certificate of Coverage at issue in this proceeding. The Certificate of Coverage is a contract between Humana and the School District. Pursuant to this contract, Humana provides an agreed-upon set of healthcare services to its subscribers in exchange for an agreed-upon sum of money. Humana's Certificate of Coverage provides coverage for durable medical equipment (hereinafter "DME"), which is defined as equipment meeting all of the following criteria: it can stand repeated use; it is primarily and customarily used to serve a medical purpose rather than being primarily for comfort and convenience (i.e., scooter to allow a patient to go shopping); it is usually not useful to a person in the absence of sickness or injury; it is appropriate for home use; it is related to the patient's physical disorder; and the equipment must be used in the subscriber's home, a relative's home, or a home for the aged or other type of institution. By the use of the word "and" to connect all of the criteria in the definition of DME, the contract provides coverage for a DME only if it meets all of the conditions. Thus, Humana is neither obligated nor authorized to provide coverage for a DME if any of the criteria in the definition are not met. The Certificate of Coverage also excludes coverage for supplies, care, or treatment that are not essential for the necessary care and treatment of an injury or sickness. The Certificate also provides that Humana has the full and exclusive discretionary authority to interpret the Plan's provisions, to make decisions regarding eligibility for coverage and benefits, and to resolve factual questions relating to coverage and benefits. The Subscriber T. O., a then-13-year-old male, underwent reconstructive knee surgery to repair a torn anterior cruciate ligament. The surgery was performed by Dr. Steven Page, an orthopedic surgeon, on August 13, 2007. Dr. Page was part of a group practice known as Brandon Orthopedic Associates, which had a contract with Humana to provide in-network healthcare to Humana subscribers and was, therefore, a participating provider. On August 7, 2007, the Subscriber's mother received an item of DME while in Dr. Page's office, which had been prescribed by Dr. Page. The DME was a cold water therapy device. She did not receive the device from Dr. Page, and he had no discussion with her regarding whether the device would be covered under her group insurance contract. Dr. Page made no representations to her regarding coverage or non-coverage, and she made no inquiry regarding whether her insurance would pay for the device. Instead, according to her own testimony, she made the decision that she would pay for the device herself if there was no coverage. In a Letter of Medical Necessity dated August 7, Dr. Page prescribed the DME to be used for 14 days following surgery. The Letter further states that the device is being prescribed for its ability to reduce pain and edema, limit the patient's hospital stay, and facilitate recovery. It further states that ice or ice substitutes cannot be used continuously due to possible tissue damage. The cold water therapy device delivered to the Subscriber was provided by Aberdeen Medical Services through office space within the office space of Dr. Page's practice group. Aberdeen does not have a contract with Humana to provide services to Humana's subscribers and is, therefore, a non- participating provider. At the same time the cold water therapy device was delivered to the Subscriber, the Subscriber's mother signed Aberdeen's Assignment Agreement. The Agreement includes a paragraph entitled Assignment of Benefits, which provides that if the Subscriber's insurance company does not pay the claim in full, the Subscriber assigns to Aberdeen all rights to any appeal granted by the Subscriber's insurance company. When the Subscriber's mother failed to bring the cold water therapy device to the hospital on the day of her son's surgery, Dr. Page instructed the Subscriber's mother to return home to retrieve the device. He did not tell her that he would not perform the surgery if she did not retrieve the device, and he would not have refused to perform the surgery for a patient who chose not to use the device. Aberdeen submitted a claim to Humana seeking to be paid $850 for the Subscriber's rental of the cold water therapy device for 14 days. Humana denied coverage for the device in September 2007, stating that there was no prior authorization on file. The contract between Dr. Page's practice group and Humana requires that prior authorization must be obtained before a Subscriber can receive treatment or services from a non- participating provider. When Humana denied Aberdeen's claim for payment, Aberdeen initiated the internal appeal and grievance process with Humana. Humana requested that Aberdeen obtain the Subscriber's consent by having the Subscriber's mother complete an Appointment of Authorized Representative Form. The Form was completed by the Subscriber's mother and returned to Humana by Aberdeen. Upon receiving confirmation that the Subscriber wished to be represented in the appeal by Aberdeen, Humana continued with the internal review process. Humana's Grievance and Appeal Panel considered the appeal and upheld the denial of coverage, stating that Humana considers the device to be a convenience item. Humana informed Aberdeen of the denial of the appeal by letter dated December 21, 2007, and further informed Aberdeen that an additional grievance procedure was available before the State's Subscriber Assistance Panel. The Subscriber's mother filed a grievance with the Subscriber Assistance Panel (hereinafter "Panel") appealing Humana's denial of the claim. The Panel heard the case on April 15, 2008. Two representatives from Humana and the Subscriber's mother appeared before the Panel by telephone. Aberdeen did not participate in the Panel review. The Panel found that the cold water therapy device is excluded from coverage under the terms of the Subscriber's Certificate of Coverage. The Panel also found that the Subscriber's mother "detrimentally relied upon the participating physician's recommendation of the cold water therapy device and she was not given any other option as to alternative treatments." The Panel determined that Humana "acted inconsistently with its obligations to the Subscriber under the rules and laws that regulated managed care entities" and recommended to the Office that Humana be ordered to provide coverage despite the device being excluded under the terms of the Certificate of Coverage. The Panel did not, however, cite to any "rules and laws" allegedly violated by Humana. By letter dated June 18, 2008, the Office adopted by reference and incorporated all the terms of the Panel's Proposed Recommended Order and ordered Humana to provide coverage for the device, finding that "coverage ordered herein is necessary in order for representations made to the Subscriber via the Member Handbook and Certificate of Coverage to be unambiguous and not violative of Sections 641.31 and 641.3903, Florida Statutes." The letter fails to specify what representations made in the Member Handbook or the Certificate of Coverage are ambiguous and fails to specify what provisions within the two lengthy statutes cited would be violated if coverage were excluded in accordance with the Certificate of Coverage. Humana filed with the Office a timely Petition for Summary Hearing, which was forwarded to the Division of Administrative Hearings on July 23, 2008. The cold water therapy device at issue consists of an 8-quart water cooler that looks like a small drink cooler, a cuff, a pump, and a hose. The pump automatically exchanges water through the hose from the pump to the cooler to provide a continuous flow of cold water through the cuff which is wrapped around the injured area. As opposed to other treatment modalities such as an ice pack/compression bandage combination or a cuff/water cooler combination, the cold water therapy device involved in this case is designed to provide a continuous flow of cold water through the cuff and eliminate the need for the patient to remove and replace ice packs or manually exchange the warmed water in the cuff with cold water from the cooler. The cold water therapy device also provides compression to the injured area because of a compression strap and the water pressure inside the cuff. The device comes with directions to use 20 minutes on and 20 minutes off, so monitoring is required. Humana requires providers to submit claims using claims codes. Humana's claims codes for cold water therapy devices include separate codes for a water-circulating cold pad with pump, for a pump for a water-circulating cold pad, and for a pad for a water-circulating unit. None of these devices or components is a covered benefit under the Certificate of Coverage involved in this case. Neither Dr. Page nor Aberdeen obtained pre- authorization from Humana before providing the cold water therapy device to the Subscriber. According to the contract between Humana and Dr. Page's practice group, pre-authorization was required before this device could be considered for coverage since it was supplied by a non-participating provider. Likewise, the Subscriber never attempted to contact Humana regarding any issue related to coverage prior to receiving this device. Aberdeen's president testified at deposition that Humana has reimbursed Aberdeen in previous claims for the cold water therapy device at issue here. However, in those situations Aberdeen was reimbursed under different policies with different coverage terms than the one at issue in this case. Moreover, if a specific code is available for a specific piece of DME, then that is the proper claims code to use for reimbursement purposes. Aberdeen has submitted claims for payment for cold water therapy devices under the claims code "E1399," a claims code that is used for unlisted DMEs. In conjunction with using that claims code, Aberdeen described the DME as being "electronic controlled thermal therapy acute pain management." This claims code and this accompanying description are not applicable to the cold water therapy device for which Aberdeen was seeking reimbursement. The correct code should have been "E0218," the code for a water-circulating cold pad with pump. Humana admits that it has paid Aberdeen two claims in error due to Aberdeen's use of the wrong code. The Subscriber's mother has paid nothing toward the rental of the cold water therapy device from Aberdeen. Aberdeen has not even sent an invoice or other request for payment to the Subscriber. Whether Aberdeen will ever seek reimbursement for the device from the Subscriber is speculative. Whether Aberdeen can seek reimbursement from the Subscriber is questionable since the Office offered into evidence two forms provided to the Subscriber by Aberdeen. One of them is entitled: "Frequently Asked Questions Regarding Your Responsibilities for the Use of the Controlled Cold Therapy Device," and the other is entitled: "Most Frequently Asked Questions Regarding Your Responsibilities for the Use of the Controlled Cold Therapy Device." Both contain the question: "Will I be personally responsible for any of the bill for my use of this device?" The first form answers the question as follows: "We accept payment consistent with the terms of your applicable insurance." The second answers as follows: "We accept payment according to the terms of your applicable insurance and this is the extent of your responsibility." Dr. Page uses the cold water therapy device for his patients who undergo surgery to repair the anterior cruciate ligament. He was impressed with an article in the American Journal of Knee Surgery, which found the device to be superior to using crushed ice. He does not, however, know the prevailing medical standard among orthopedic surgeons as to use of the device. The fact that he knows many who do does not establish a standard of care. He agrees that not everything deemed medically necessary is covered by insurance and that under his contract with Humana, Humana has the authority to determine that the device is a convenience item and not a covered benefit. Dr. Louis Hochheiser is Humana's Medical Director for clinical policy development. He oversees the committee that is responsible for examining new medical technologies, as well as writing and reviewing clinical policies. A clinical policy provides guidance to Humana's providers so they know what Humana covers, and it also serves as guidance for physicians and nurses doing case review to help ensure that all of Humana's subscribers are treated equally. The clinical policies are published on Humana's website and are available to its subscribers and providers. When Humana is developing a clinical policy for a medical technology or device such as the cold water therapy device at issue in this case, a workgroup of the committee researches the device using medical literature and any statement or assessment that any specialty organization may have made on that particular device. Humana also subscribes to the services of two companies that examine and rate new technologies. Humana also consults the rules of the Center for Medicare and Medicaid Services and reviews its competitors' positions with respect to any new technology. When the workgroup has compiled and reviewed the information, it creates a draft clinical policy. One of the medical directors of the full committee then reviews the draft policy form and all the literature that was reviewed in creating the draft policy form. If necessary, the draft policy is revised after discussion and further research. Once the draft policy is approved, it is sent to the full committee for presentation, discussion, and approval. When the policy is approved, it is posted on Humana's website and sent to its providers as part of a quarterly update of new and revised policies. The provider contract between Humana and Dr. Page's practice group that requires the group's physicians to comply with Humana's policies and procedures includes such policies. The voting members of the committee are physicians from three different areas of Humana: regional medical directors, market medical officers who work with Humana's providers, and Medicare medical directors. Approximately 20 physicians participate in the committee on a monthly basis. Additional input is provided by nurses, legal counsel, product development, sales and communications, but the voting and approval of clinical policies is only done by physicians. The committee does not consider cost of the technology when it creates Humana's clinical policy forms but relies on medical evidence to make its decisions. If a technology is supported by the medical evidence, and if it makes improvements for Humana's subscribers, then the committee will approve the technology. If such approval results in a higher cost, this increased cost is addressed by Humana's actuaries and built into the cost of the health plan. With respect to the development of the clinical policy on the cold water therapy device at issue in this case, Humana's technology assessment forum reviewed journal articles, information supplied by the two organizations that provide reviews of technology, and literature from the Institute of Arthritis and Musculoskeletal Skin Diseases' web site to determine the efficacy of cold and heat therapy based on the published literature. There is no reliable evidence that cold water therapy devices provide better outcomes for patients than traditional cold packs. The only advantage to the cold water therapy devices compared to cold packs is that of convenience because the patient does not have to change cold packs if the patient is using the cold water therapy device.
