18 - ICD10 SpecialtyTips Oral Maxillofacial-2 - abeo.com · ICD$10!SPECIALTYTIPS’...

ICD-‐10 SPECIALTY TIPS

ORAL & MAXILLOFACIAL | 1 of 6

SPECIALTY TIP #18 Oral & Maxillofacial The following information was obtained from several carrier sources: Most carriers will cover medically necessary reconstructive surgery and procedures performed on abnormal structures of the body caused by congenital defects, developmental abnormalities, trauma, infection, tumors, or disease when there is a physical functional impairment or ongoing medical complication that is expected to be improved upon with the requested procedure. They may also consider reconstructive/restorative procedures of the face to correct severe disfigurement depending on the circumstances. Reduction of any facial bone fractures is usually covered under medical plans as would the removal of tumors, treatment of dislocations, facial and oral wounds/lacerations, and removal of cysts or tumors of the jaws or facial bones, or other diseased tissues. A dental service may be a covered medical expense if the dental service is medically necessary and is incident to and an integral part of a service covered under the medical plan.

• Examples: o Reconstruction of a dental ridge distorted as a result of removal of a tumor (including bone grafting and dental implants if

necessary to stabilize a maxillofacial prosthesis such as an obturator). o Removal of broken teeth necessary to reduce a jaw fracture

Reconstructive procedures require prior authorization in order to determine the benefit coverage and/or the medical necessity of the procedure. Simultaneous procedures may be medically necessary to provide functional improvement. When more than one procedure is requested, you will probably need to provide documentation that satisfies the criteria for each procedure before services may be authorized. For some conditions, a planned staged procedure may be medically appropriate, but for most conditions, only the initial reconstructive procedure will be authorized unless a significant functional impairment or ongoing medical complication remains, and medical review criteria are met. For planned staged procedures, be sure to specify that multiple surgeries or procedures will be needed when obtaining the initial authorization. Anesthesia for Dental or OMS Services General anesthesia and MAC may be considered medically necessary for dental or OMS services if any of the following criteria is met:

• The patient is a child, up to 6 years old, with a dental condition (such as baby bottle syndrome) that requires repairs of significant complexity (e.g., multiple amalgam and/or resin-‐based composite restorations, pulpal therapy, extractions or any combinations of these noted or other dental procedures); or

• Patients who exhibit physical, intellectual, or medically compromising conditions, for which dental treatment under local anesthesia, with or without additional adjunctive techniques and modalities, cannot be expected to provide a successful result and which, under anesthesia, can be expected to produce a superior result. Conditions include but are not limited to mental retardation, cerebral palsy, epilepsy, cardiac problems and hyperactivity (verified by appropriate medical documentation); or

• Patients who are extremely uncooperative, fearful, unmanageable, anxious, or uncommunicative members with dental needs of such magnitude that treatment should not be postponed or deferred and for whom lack of treatment can be expected to result in dental or oral pain, infection, loss of teeth, or other increased oral or dental morbidity; or

• Patients for whom local anesthesia is ineffective (such as due to acute infection, anatomic variations or allergy); or • Patients who have sustained extensive oral-‐facial and/or dental trauma, for which treatment under local anesthesia would be

ineffective or compromised; or • Patients with bony impacted wisdom teeth.

According to guidelines from the American Academy of Pediatric Dentistry (AAPD, 2004 and 2005), the indications for deep sedation and general anesthesia in pediatric dental patients include:

• Patients with certain physical, mental or medically compromising conditions; • Patients with dental restorative or surgical needs for whom local anesthesia is ineffective; • Patients who are extremely uncooperative, fearful, anxious including physically resistant children or adolescents with substantial

dental needs and no expectation that the behavior will improve soon; • Patients who have sustained extensive orofacial or dental trauma; • Patients with dental needs who otherwise would not receive comprehensive dental care.

Keep in mind, documentation of inclusive conditions need to be present for consideration for reimbursement.



The Basics Medically necessary oral and maxillofacial surgery and procedures may be covered when relevant criteria are met.

Condition Documentation Needed Significant skeletal abnormality that causes a disabling functional malocclusion Note: Photographs and radiographs must be taken within 3 months of the procedure.

•Significantly impaired chewing and eating functions secondary to jaw misalignment with the potential for weight loss, inadequate growth, and/or nutritional deficiency due to interference with eating; •Documentation of the patient history, symptoms and functional impairment, exam, diagnosis, and proposed treatment plan including any prior or dietary advice or nutritionist counseling; •Photographs of the occlusion (right, left, and center); •Current panorex radiographs, and cephalometric radiographs including lateral and posterior-‐anterior orientation (where indicated) with analysis, and any other tracings, imaging, or other information that support analysis or treatment plan; and •The condition cannot be treated by orthodontic treatment alone.

Poor intelligibility when speaking in sentences.

•In addition to documentation of the patient history, symptoms and functional impairment, exam, diagnosis, and proposed treatment plan and expected improvement, •A Speech Language Pathology evaluation may be required to substantiate degree of impairment in phonation and failed treatment intervention, and to attest to the expected improvement from surgery.

Surgical correction of skeletal abnormalities associated congenital and syndromatic craniofacial anomalies

Requires repair for nutritional or airway compromise or for brain development, such as: Pierre Robin syndrome, Apert syndrome, or Treacher Collins •There must be documentation of the clinical history, and exam photos, Panorex radiographs, and cephalometric radiographs including lateral and posterior-‐anterior orientation (where indicated) with analysis, and any other tracings, imaging, or information that supports the analysis or treatment plan.

Medically necessary treatment of an oral/maxillofacial tumor, facial fractures and dislocations, or osteoradionecrosis of the jaw due to head and neck radiation

•There must be a documentation of the clinical history and exam, documentation of x-‐rays, CT scan, and/or photographs demonstrating bone involvement when applicable.

Airway dysfunction that is due to a significant skeletal abnormality and not amenable to non-‐surgical treatment

For maxillomandibular advancement or mandibular advancement for sleep apnea there must be medical record documentation of the following: •Moderate or severe OSA (AHI/RDI ≥15) ; or mild apnea (AHI/RDI 5-‐14) with significant O2 desaturations and/or Epworth sleepiness scale of >9 •Failure of PAP titration or adherence despite coaching and treatment adjustments, or for mild OSA failure of an oral appliance due to ineffectiveness or intolerance. •If the patient is obese weight loss must be discussed. •The requested surgical procedure is expected to significantly improve their OSA as evidenced by lateral cephalometric radiographs with tracings, measurements and predictions, or by 3D CT scan of the upper airway; or For other skeletal abnormalities causing airway compromise there must be: •Documentation of the clinical history, photos, Panorex radiographs, and cephalometric radiographs including lateral and posterior-‐anterior orientation (where indicated) with analysis, and any other tracings, imaging, or information that supports the analysis or treatment plan.

Severe temporomandibular joint pain and dysfunction (limitation in mobility or persistent intermittent locking)

When conservative, non-‐surgical interventions have failed, and when there is documentation of these failed treatments, MRI or other imaging confirming boney and/ or joint abnormalities that would require and be amenable to the proposed treatment, including therapeutic arthroscopy, arthroplasty/arthrotomy and joint replacement •Therapeutic arthroscopy for internal disc derangement requiring internal modification in the absence of minimal or no degenerative disc changes. •Arthroplasty/arthrotomy including discectomy: for osteoarthritis, severe disc displacement associated with degenerative changes or perforation, or for severe scarring resulting from injury or prior procedure. •Joint replacement with a prosthesis or autologous costo-‐chondral grafting: considered end-‐stage treatment for severe degenerative joint pathology when other surgical treatment modalities have been unsuccessful. Treatment may be considered for: temporal bone without smooth articular fossa, damaged condyles no longer ball shaped, loss of mandibular condylar height and/or occlusional relationship, persistent inflammatory arthritis, recurrent fibrous or bony ankylosis, failed autologous bone graft or alloplastic reconstructive effort.

Trauma to the face •The circumstances of the accidental trauma and the degree of injury are well documented by clinical notes. (Photos may be required). •The procedure must be requested and performed within 12 months of the accidental injury; or -‐For children who have not reached full maturity (i.e. age 16 or less), the medical record must document that a delay greater than 12 months for performing the initial restorative procedure was required in order for growth to be complete; or -‐For any other delay greater than 12 months, the medical record must document that the postponement of the initial restorative procedure was required in order for optimal reconstruction, healing, and remodeling. •The requested procedure can be reasonably expected to have a successful outcome.

Lesions ALWAYS document the size, number, and location of EACH lesion •Excision is defined as full-‐thickness including simple (non-‐layered closure) -‐ For excisions requiring more than a simple closure, be sure to document in •Size is determined by measuring the greatest clinical diameter plus the margin -‐ Do not depend on the path report for size (it will shrink thereby defaulting to a lesser value -‐ If no size is given, the coding must default to the lesser code •If known, document type of lesion (malignant, benign, epidermal, etc.). -‐ Should we look for a path report? Note on op report if specimen is sent to path



• Your verbiage may sway the decision for coverage; therefore, if the condition meets the criteria for reconstructive/corrective surgery, emphasize the medical necessity rather than just cosmetic reasons for the case.

o The H&P or consult may be requested for the medical review, those documents are ideal to illustrate the need for treatment. X-‐rays or a path report may also be needed support medical necessity in some instances.

o Do not forget to include pertinent information and diagnoses in your surgical op report. Often, the supporting diagnosis (contracture from burn scarring, etc.) may be missing from the op reports and the H&P or consult are needed in order to obtain the information thus causing a delay in submitting the claim.

• Provide adequate history to identify any former surgeries or conditions affecting treatment o Often it is difficult to differentiate whether the current surgery is the initial procedure or is this surgery:

§ A repeat surgery (-‐76 modifier if same surgeon, -‐77 modifier by a different surgeon), § A planned, staged procedure (-‐58 modifier if within the postoperative global period), § For a different condition (thereby starting the global “clock” for a different condition, -‐79 modifier), § A correction of a defect (different diagnosis noting a complication) § An unplanned return to the operating room for a related procedure (-‐78 modifier)

o For staged procedures, when was the last surgery? § Is this within the global period of the previous surgery?

o Otherwise, what condition has prompted the current surgery? • When seeing a patient, the coding would depend on the INTENT of the visit. See the chart in Specialty Tip #8; this may help to

determine whether a consult or a visit code would be most appropriate. • For Consults, you cannot self-‐refer. There must always be a request for your services in the medical record in order to qualify for a

consult as well as documentation of your response back to the requesting provider o If you assume all or a portion of care for the patient, it is no longer considered a consult but a visit

• YOUR documentation should easily clarify the intent of the visit. Keep in mind that Charge Tickets are not a part of a legal medical record.

• When requesting a prior authorization, check that the facility would be appropriate for the procedure (inpatient versus outpatient). Some procedures can only be performed in the inpatient setting.

Diagnosis It is all in the details of your documentation as to whether a claim could be a “paying” diagnosis for a procedure or whether it (they) would not medically support payment by an insurance company with the expense falling to the patient. Diagnoses tell a story of why a procedure is needed and your documentation illustrates that medical necessity. ICD-‐10 opens up a wider range of coding opportunities.

• If applicable, always state laterality. o Keep in mind that it is now easier to code for different conditions in contralateral locations supporting procedures that

might otherwise be bundled together. • Location, location, location...always be site specific and detail anatomical locations. • Identify acute versus chronic conditions. • For musculoskeletal conditions and injuries, state whether the patient is:

o In the treatment phase (surgery, Emergency Department, evaluation and treatment by new physician, etc.), o In the healing phase (cast change or removal, medication adjustment, aftercare following treatment), o Or is this a late effect/sequela of an injury?

• When treating a sequela for an injury you need to gather information on the mechanism of the injury o Details of the original injury (“closed fracture of the nasal bone with a dislocation of the septal cartilage of the nose”) o When did the original injury occur? (Date) o What happened? (“driver in an MVA”, “slip and fall in home”, “hit by a baseball”, etc.)

• Rather than a current condition, are you treating a late effect or should this be termed a “history of”? o “History of” codes, especially malignancies may help to support reconstruction codes.

• Coding rules dictate that when coding for multiple conditions, the more severe or acute code is sequenced first with chronic conditions as secondary.

o Be sure to qualify the severity of the condition. Diagnostic sequencing depends on severity (acute over chronic, etc.) o In addition, for E&M coding, those descriptive words help in the medical decision making portion of the visit

• State acute or chronic, old injury, any descriptive wording that help to illustrate the condition. o Example: “Glaucoma, early stage”

• State any “due to” or precipitating conditions. • Include comorbid and relevant conditions that impact decision making or might complicate surgery . • Update your diagnosis for the current service being provided especially in bringing forward visits in an EMR:

o While prior conditions may have originally prompted the visit, would they still be relevant? o Unless a condition is under treatment or has an impact on the condition under treatment, it would not be considered

relevant.



• For chronic patients, new conditions are relevant and can impact the medical decision making IF they are addressed (i.e. during the examination, within the plan, etc.)

• If a patient is pregnant, always include trimester and number of weeks regardless of the setting. o The only time pregnancy is considered incidental is when it is documented as such. Otherwise it is coded as “Pregnancy

complicated by...” • Be sure that you are listing as your diagnosis the condition YOU are treating (i.e. COPD under treatment by a Pulmonologist, atrial

fibrillation treated by a Cardiologist, etc.) • Certain conditions (neoplasms, respiratory, etc.) ask for additional information regarding alcohol and tobacco use, abuse, exposure

to, or history of (see specifics below). • Codes for Postop Complications are expanded in ICD-‐10 and a distinction is made between intraoperative complications and

postprocedural disorders. o Not all conditions that occur during or following medical care or surgery are classified as complications

§ There must be a cause-‐and-‐effect relationship between the care provided and the condition, and § An indication in the documentation that it is a complication. This cannot be assumed.

o A condition that is normal and expected post-‐operatively is not a complication

Condition Additional Information Needed

Alcohol dependence – (F10-‐) (Applicable to many dx codes)

•Use, abuse, or dependence of alcohol? •Blood alcohol level if applicable •With other related disorders (withdrawal, intoxication, in remission, mood disorder, etc.)?

Bleeding, post-‐op •Specific to intraoperative or postprocedural. •Specific to system / location.

Cancer

•Site? Laterality when applicable? -‐Example: C50.211 Malignant neoplasm of upper-‐inner quadrant of right female breast •Asks for additional code to identify alcohol abuse and/or dependence • Other condition(s) associated with malignancy – (dehydration, anemia, etc.) •Complication(s) associated with neoplasm •Include estrogen receptor status (if applicable)

●Document morphology: -‐ Malignant (Primary) -‐ Secondary -‐ Benign -‐ In situ -‐ Uncertain behavior -‐ Unspecified behavior -‐Overlapping sites

For “History of”, document: -‐Has the malignancy been excised or eradicated? -‐Is there still treatment being provided for the primary and/or secondary site? -‐Is there evidence of remaining malignancy at the primary site? -‐Document any associated diagnoses/conditions

Complications: • Internal device, implant,

and graft • Mechanical/Hardware • Infection or

inflammation

•If a complication of surgery, state whether intraoperative or postoperative •Be sure to designate the cause and effect relationship to illustrate the complication •Specify nature of the complication: -‐ Breakdown -‐ Displacement -‐ Hemorrhage, seroma

-‐ Pain -‐ Stenosis -‐ Embolism -‐ Leakage

-‐ Obstruction -‐ Perforation -‐ Protrusion -‐ Stitch dehiscence

Tobacco Use Disorder – (Applicable to many dx codes)

•Document type: -‐ Cigarettes -‐ Chewing tobacco -‐ Other

•Delineate between: -‐ Tobacco use/abuse (Z72.0) -‐ Tobacco dependence (F17-‐) -‐ History of (Z87.891) -‐ Exposure to environmental tobacco smoke (Z77.22) -‐ Exposure to tobacco smoke in the prenatal period (P96.81)

•Document state of dependence: -‐ In remission -‐ With withdrawal -‐ Without withdrawal

Cosmetic surgery codes Z41.1: Encounter for cosmetic surgery Z41.8: Encounter for other procedures for purposes other than remedying health state Z41.9: Encounter for procedure for purposes other than remedying health state, unspecified

Fractures

Codes for fractures are classified on the basis of following: • Traumatic or Pathologic (+ underlying condition)? • Specific anatomical information type of fracture • Open or closed • Displaced or non-‐displaced?

Right, Left, or Bilateral? • Episode of Care:

-‐ Initial (treatment phase)/ subsequent -‐ (Routine healing/ Delayed healing, Non-‐union/ Malunion) Initial or subsequent encounter? -‐ Or Sequela (detail original injury)?



Some diagnosis common to OMS:

ICD-10 Codes Diagnosis Q35.1 Cleft hard palate Q35.3 Cleft soft palate Q35.5 Cleft hard palate with cleft soft palate Q35.7 Cleft uvula Q35.9 Cleft palate, unspecified Q36.0 Cleft lip, bilateral Q36.1 Cleft lip, median Q36.9 Cleft lip, unilateral Q37.0 Cleft hard palate with bilateral cleft lip Q37.1 Cleft hard palate with unilateral cleft lip Q37.2 Cleft soft palate with bilateral cleft lip Q37.3 Cleft soft palate with unilateral cleft lip Q37.4 Cleft hard and soft palate with bilateral cleft lip Q37.5 Cleft hard and soft palate with unilateral cleft lip Q37.8 Unspecified cleft palate with bilateral cleft lip Q37.9 Unspecified cleft palate with unilateral cleft lip C03.0 -‐ C03.9 Neoplasm, malignant of gum C41.0 -‐ C41.1 Neoplasm, malignant of bones of skull and face and mandible C76.0 Neoplasm, malignant of head, face, and neck D10.30 -‐ D10.39 Neoplasm, benign of other and unspecified parts of mouth D16.4 -‐ D16.5 Neoplasm, benign of bones of skull and face and lower jaw bone K09.0 -‐ K09.1 M27.0 -‐ M27.9 Diseases of jaws

M26.211 -‐ M26.29 Anomalies of dental arch relationship M26.30 -‐ M26.39 Anomalies of tooth position of fully erupted tooth or teeth Numerous options Open wound of head, neck, and trunk, sequela

S01.401+ -‐ S01.95x+ Open wound of face, internal structures of mouth, or other and unspecified, without mention of complication, or complicated

S02.0xxS -‐ S02.92xS Fracture of skull and face bones, sequela S02.400+ -‐ S02.42x+ S02.600 -‐ S02.69x+ Fracture of malar, maxillary, zygoma and mandibular bones, closed or open

S03.0xx+ Dislocation or jaw S09.10x+ -‐ S09.19x+ S09.8xx+, S09.90x+ -‐ S09.93x+

Injury to head, face, and neck

T84.81x+ -‐ T84.89x+ Other specified complications of internal orthopedic prosthetic devices, implant, and grafts T85.21x+ -‐ T85.318 T85.390 -‐ T85.398 T85.618

Mechanical complication of other specified prosthetic device, implant, and graft due to other implant and internal device, not elsewhere classified

T85.79x+ Infection and inflammatory reaction due to other internal devices, implants and grafts Z01.20 -‐ Z01.21 Encounter for dental examination and cleaning

Dental ICD-‐10 has added coding that more specifically details the extent of teeth loss and whether caries is limited to the enamel, dentin, or pulp. It asks for additional codes to identify alcohol abuse or dependence (F-‐10-‐) and/or use/dependence/history of/or exposure to tobacco. There are a number of new ICD-‐10 codes for Dental. Note the Edentulism Classifications for loss of teeth at the bottom of the following diagnostic code list. When treating situations involving a traumatic injury, in addition to the details of the condition, you will need to also gather information regarding the mechanism of injury:

1. When did the original injury occur? (Date) 2. What happened? (“driver in an MVA”, “slip and fall in home”, “bitten by a neighbor’s dog”, “playing soccer”, etc.) The more detail

the better. And, yes, this is where some of those really amusing scenarios for a vast array of event codes come in. More and more often, we are being asked to provide this information. When the information is not provided, an extensive amount of follow-‐up has to be done in order to garner the information to complete the billing (often necessitating obtaining information from the patient’s primary care). For every denial or request for information, there is a time delay in payment of the claim.



ICD-‐10 Codes Diagnosis

K00.2 Abnormal Size-‐ teeth K00.3 Mottled teeth K00.4 Disturbance of formation K00.5 Disturbance of tooth structure K00.6 Disturbance of tooth eruption K02.9 Dental Caries

K02.52 Dental Caries-‐ on pit/fissure surface penetrating into dentine

K02.62 Dental Caries-‐ on smooth surface penetrating into dentine K02.53 Dental Caries-‐ on pit/fissure surface penetrating into pulp K02.63 Dental Caries-‐ on smooth surface penetrating into pulp K03.0 Excessive Attrition K03.1 Abrasion – dental K03.1 Abrasion-‐ localized K03.1 Abrasion-‐ generalized K03.2 Erosion of teeth-‐ unspecified K03.2 Erosion of teeth-‐ localized K03.5 Accretions On Teeth M26.72 Alveolar Mandibular Hyperplasia

K08.0 Exfoliation Of Teeth Due To Systemic Causes – Code also underlying systemic condition

Complete Loss Of Teeth Due To Periodontal Disease, K08.121 Class I K08.123 Class III K08.122 Class II K08.124 Class IV

K08.129 Complete Loss of Teeth Due to Periodontal Disease, Unspecified Class

Partial Los of Teeth Due to Periodontal Diseases, K08.421 Class I K08.423 Class III K08.422 Class II K08.424 Class IV

K08.429 Partial Loss of Teeth Due to Periodontal Diseases, Unspecified Class

K08.50 Unspecified defective dental restoration K08.52 Unrepairable overhanging of dental restorative materials K08.531 Fractured Dental Restorative Material W/ Loss Of Material K08.56 Poor Aesthetics Of Existing Restoration K12.2 Cellulitis And Abscess Of Oral Soft Tissues K13.21 Leukoplakia Of Oral Mucosa, including tongue K13.3 Hairy leudoplakia K14.8 Other Specified Conditions Of The Tongue

Complete Loss Of Teeth Due To caries, K08.131 Class I K08.133 Class III K08.132 Class II K08.134 Class IV K08.139 Complete Loss of Teeth Due to Caries, Unspecified Class

Partial Los of Teeth Due to caries, K08.431 Class I K08.433 Class III K08.432 Class II K08.434 Class IV K08.439 Partial Loss of Teeth Due to caries, Unspecified Class K08.51 Open Restoration Margins

K08.530 Fractured Dental Restorative Material Without Loss of Material

K08.54 Contour Incompatible With Oral Health M27.3 Alveolitis Of Jaw, Alveolar osteitis K13.0 Diseases Of Lips, Abscess K14.5 Plicated Tongue

M26.30 Vertical Displacement Of Alveolus & Teeth Unspecified anomaly of tooth position of fully erupted tooth or teeth

M26.79 Other specified alveolar anomalies Complete Loss Of Teeth Due To Trauma,

K08.111 Class I K08.113 Class III K08.112 Class II K08.114 Class IV K08.119 Complete Loss of Teeth Due to Trauma, Unspecified Class

Partial Los of Teeth Due to Trauma, K08.411 Class I K08.413 Class III K08.412 Class II K08.414 Class IV K08.419 Partial Loss of Teeth Due to Trauma, Unspecified Class K03.1 Abrasion Of Teeth, Generalized K03.5 Ankylosis Of Teeth K04.0 Pulpitis K04.4 Acute Apical Periodontitis K04.7 Periapical Abscess Without Sinus K04.5 Chronic Apical Periodontitis K04.6 Periapical Abscess With Sinus K05.00 Acute Gingivitis K05.10 Chronic Gingivitis K06.0 Gingival Recession, Unspecified K05.21 Aggressive Periodontitis, Localized K05.22 Aggressive Periodontitis, Generalized K05.31 Chronic Periodontitis, Localized K05.32 Chronic Periodontitis, Generalized M26.71 Alveolar Maxillary Hyperplasia

Other Conditions Influencing Care F70 Mild Mental Retardation Q90.9 Down Syndrome, unspecified F84.0 Autistic Disorder, Current or Active State F90.9 ADHD, unspecified type G80.9 Cerebral Palsy NOS R56.9 Seizure Disorder J45.909 Asthma, unspecified, uncomplicated F71 Moderate Mental Retardation F72 Severe Mental Retardation F73 Profound Mental Retardation F41.1 Generalized Anxiety Disorder

Q04.9 Congenital Encephalopathy Congenital malformation of brain, unspecified

Q06.9 Congenital malformation of spinal cord, unspecified Q07.9 Congenital malformation of nervous system, unspecified R01.1 Heart Murmur F41.9 Anxiety state, Unspecified F41.0 Panic Disorder w/o agoraphobia

Edentulism Classifications Class I Ideal or minimally compromised Class II Moderately compromised Class III Substantially compromised Class IV Severely compromised

The information provided is only intended to be a general summary and not intended to take place of either written law or regulations.

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