genital tract infections,obtetric and gynaecologi nrsing

GTI

1. GENITAL TRACT INFECTION

2. NORMAL DEFENCE MECHANISM Vulva: Apocrine glands: modified sweat glands → fungicidal acid Apposition of labia closes introitus Vagina: Apposition of anterior and posterior walls Stratified squamous epithelium resistant to infection Vaginal acidity

3. Flora: the doderlein’s bacilli splits glycogen into lactic acid Cervix: Closed by bacteriolytic cervical mucus Uterus: Period ic endometrial shedding during menstruation eliminates any infection

4. Reproductive tract infections include two types of infection: Venereal [STD] Non venereal diseases

5. VULVAL INFECTIONS BACTERIAL VIRAL FUNGAL PARASITIC

6. VULVAL CELLULITIS The causative organism is predominantly Staphylococcus aureus . The vulva is swollen, red, and tender. The patient complains of intense pain, itching and problem in micturition . There may be excoriation of the skin due to scratching and laceration. Treatment is effective by systemic antibiotics, local hot compress and analgesics.

7. FURUNCULOSIS The infection affects the hair follicles of the mons and labia majora → folliculitis → furunculitis The offending organism is Staphylococcus aureus . Treatment is effective with systemic and local antibiotics and local cleanliness

8. Impetigo: Impetigo is a pustular infection caused by Staphylococcus aureus or Streptococcus. It may be localized to vulva or spread to other parts of the body, face, or hands. Systemic and local antibiotics are to be prescribed.

9. Erysipelas: This rare spreading cellulitis is caused by invasion of the superficial lymphatic by b- haemolytic Streptococcus. There may be systemic constitutional symptoms. It responds well to systemic broad spectrum antibiotics.

10. Herpes zoster: The causative agent is varicella zoster virus It produces an inflammatory painful eruption of groups of vesicles distributed over the skin. It is commonly unilateral but may extend to the thigh or buttock of the same side. The vesicles may rupture or become dry with scab formation. It resolves spontaneously in 3 weeks time. Treatment is by analgesics to relieve pain and antibiotics to prevent secondary infection. Acyclovir 800 mg orally five times daily for 7 days is recommended. Acyclovir cream (5%) may be used locally for less severe infection.

11. Ringworm: The causative organism is Tinea cruris . The lesions look bright red and circumscribed. The fungus can be detected microscopically from scraping of the lesion. Treatment is very effective with imidazole ( clotrimazole or miconazole ) cream.

12. Threadworm: The causative organism is Oxyuris vermicularis . It is common in children. Nocturnal perineal itching with evidences of perianal excoriation is observed. The parasite is detected in the stool. Antihelmintic drugs such as mebendazole and local application of gentian violet cures the condition.

13. INFECTIONS OF BARTHOLIN’S GLAND BARTHOLINITIS: Causative Organisms: Escherichia coli, Staphylococcus, Streptococcus, or Chlamydia trachomatis Clinical Features: local pain and discomfort, difficulty in walking or sitting. Examination reveals tenderness and induration of the posterior half of the labia. The duct opening looks congested and secretion comes out through the opening Treatment: Hot compress over the area and analgesics to relieve pain are instituted. Systemic antibiotic like ampicillin 500 mg orally 8 hourly is effective

14. INFECTIONS OF BARTHOLIN’S GLAND Bartholin’s cyst There is closure of the duct. The cause may be infection or trauma followed by fibrosis and occlusion of the lumen. Clinical features: a small size often remains unnoticed. If it becomes large (size of hen’s egg), there is local discomfort and dyspareunia . Examination reveals a unilateral swelling on the posterior half of the labium majus . Its medial projection makes the vulval cleft ‘s’-shaped. The overlying skin is thin and shiny. Treatment: marsupialization is the gratifying surgery for bartholin’s cyst.

15. VAGINAL INFECTION BACTERIAL VAGINOSIS Bacterial vaginosis is a type of vaginal inflammation caused by the overgrowth of bacteria naturally found in the vagina, which upsets the natural balance. Clinical Features: Thin, gray, white or green vaginal discharge Foul-smelling "fishy" vaginal odor Vaginal itching Burning during urination Painful micturition .

16. VAGINAL INFECTION Golden test-gram staining Treatment: Simple perineal hygiene will relieve the symptoms, estrogen cream is to be applied locally, every night for two weeks. When the specific organisms are detected, therapy should be directed to cure the condition Metronidzole and clindamycin [ 2 nd choice]

17. CANDIDA VAGINITIS (MONILIASIS) Causative Organism - Moniliasis is caused by Candida albicans , a grampositive yeast-like fungus Predisposing factors for Candida vaginitis Diabetes Pregnancy Broad spectrum antibiotics Combined oral pills Immunosuppression Drugs–steroids Thyroid, Parathyroid disease Obesity

18. CANDIDA VAGINITIS (MONILIASIS) Clinical Features The patient complains of vaginal discharge with intense vulvovaginal pruritus . The pruritis is out of proportion to the discharge. There may be dyspareunia due to local soreness. On examination: The discharge is thick, curdy white and in flakes, (cottage cheese type) often adherent to the vaginal wall .Vulva may be red and swollen with evidences of pruritus . Vaginal examination may be tender. Removal of the white flakes reveals multiple oozing spots.

19. Diagnosis: Wet Smear of vaginal discharge and Culture Treatment: Local fungicidal preparations Nystatin , clotrimazole , miconazole , econazole are used in the form of either vaginal cream or pessary . One pessary is to be introduced high in the vagina at bedtime for consecutive 2 weeks. Single dose oral therapy with fluconazole (150 mg) or itraconazole is also found effective Husband should be treated with nystatin ointment locally for few days following each act of coitus. The use of condom is preferred.

20. ATROPHIC VAGINITIS (SENILE VAGINITIS) Vaginitis in postmenopausal women is called atrophic vaginitis . There is atrophy of the vulvovaginal structures due to estrogen deficiency. The vaginal defence is lost. Vaginal mucosa is thin and is more susceptible to infection and trauma. There may be desquamation of the vaginal epithelium which may lead to formation of adhesions and bands between the walls.

21. CERVIX CERVICITIS The term cervicitis is reserved to infection of the endocervix including the glands and the stroma . The infection may be acute or chronic. ACUTE CERVICITIS The endocervical infection usually follows childbirth, abortion, or any operation on cervix. Clinical Features: The vaginal examination is painful. The cervix is tender on touch or movements. Cervix looks edematous and congested. Mucopurulent discharge

22. Treatment: High vaginal and endocervical swabs are taken for bacteriological identification and drug sensitivity test. Appropriate antibiotics should be prescribed. General measures are to be taken as outlined in acute pelvic infection. CHRONIC CERVICITIS Chronic cervicitis is the commonest lesion found in women attending gynecologic outpatient. It may follow an acute attack or usually chronic from the beginning

23. Clinical Features: There may not be any symptom as it may be accidentally discovered during examination (a) The cervix may be tender to touch or on movement. (b) Mucoid or mucopurulent discharge. There may be enlargement, congestion, or ectropion of the cervix. Treatment Cervical scrape cytology to exclude malignancy is mandatory prior to any therapy The diseased tissue may be destroyed by electro or diathermy cauterization or laser or cryosurgery.  

24. ENDOMETRITIS During childbearing period, infection hardly occurs in the endometrium except in septic abortion or puerperal sepsis and acute gonococcal infection. ACUTE- It almost always occurs after abortion or childbirth. CHRONIC- It is indeed rare for chronic endometritis to occur during reproductive period even following acute PID. Women often presents with purulent or seropurulent vaginal discharge. Diagnosis is made by cervical smear, culture of the discharge, transvaginal - ultrasonography and histology, of the endometrium .

25. ENDOMETRITIS Treatment: The offending cause is to be removed or eradicated. Levofloxacin 500 mg PO daily for 14 days with Metronidazole 400 mg PO twice daily for 14 days are given ATROPHIC ENDOMETRITIS (Senile endometritis ) Following menopause, due to deficiency of estrogen, the defense of the uterocervicovaginal canal is lost. As a result, organisms of low virulence can ascend up to infect the atrophic endometrium .

26. Clinical Features: The postmenopausal women complain of vaginal discharge, at times offensive or even blood-stained. Purulent discharge may be seen escaping out through the cervix Diagnosis The diagnosis is confused with carcinoma of the endometrium which must be excluded prior to treatment Ultrasonography (TVS),Diagnostic curettage Treatment: In women with recurrent attacks, hysterectomy should be done

27. ENDOMETRITIS PYOMETRA Collection of pus in the uterine cavity is called pyometra . The prerequisites for pyometra formation are : Occlusion of the cervical canal. Enough sources of pus formation inside the uterine cavity. Presence of low grade infection

28. ENDOMETRITIS Causes Obstetrical—The only condition is following infection of lochiometra . Gynecological— Carcinoma in the lower part of the body of uterus, Senile endometritis , Infected hematometra following amputation, Tubercular endometritis Clinical Features: Intermittent blood stained purulent offensive discharge Pain in lower abdomen Per abdomen: an uniform suprapubic swelling may be felt of varying size

29. ENDOMETRITIS Diagnosis is confirmed by dilatation of the cervix, all types of investigations are to be made to exclude malignancy of the body of the uterus and endocervix Treatment: Once malignancy is excluded, the pyometra is drained by simple dilatation of the cervix. Even in non-malignant cases or in cases of recurrence , hysterectomy may be indicated. Definite surgery for malignancy is to be done following drainage of pus.

30. SALPINGITIS Infection of the fallopian tube is called salpingitis . Organisms responsible for salpingitis Sexually transmitted: Gonococcus Chlamydia trachomatis , Mycoplasma (rarely) Pyogenic: #Aerobes – Streptococcus, Staphylococcus, E. coli #Anaerobes – Bacteroides fragilis , Actinomycosis Tubercular: Mycobacterium tuberculosis Etiology I. Ascending infection from the uterus, cervix and II. Direct spread from the adjacent infection II. Tubercular

31. SALPINGITIS Symptoms of salpingitis In milder cases, salpingitis may have no symptoms. This means the fallopian tubes may become damaged without the woman even realising she has an infection. The symptoms of salpingitis may include: Abnormal vaginal discharge, such as unusual colour or smell, Spotting between periods, Dysmenorrhoea (painful periods) Pain during ovulation, fever,abdominal pain on both sides lower back pain, frequent urination nausea and vomiting

32. SALPINGITIS Types of salpingitis Acute salpingitis , the fallopian tubes become red and swollen, and secrete extra fluid so that the inner walls of the tubes often stick together. In rare cases, the tube ruptures and causes a dangerous infection of the abdominal cavity (peritonitis). Chronic salpingitis usually follows an acute attack. The infection is milder, longer lasting and may not produce many noticeable symptoms. Diagnosis of salpingitis General examination - to check for localised tenderness and enlarged lymph glands

33. SALPINGITIS Pelvic examination - to check for tenderness and discharge Blood tests - to check the white blood cell count and other factors that indicate infection Mucus swab - a smear is taken to be cultured and examined in a laboratory so that the type of bacteria can be identified Laparoscopy - in some cases, the fallopian tubes may need to be viewed by a slender instrument inserted through abdominal incisions .

34. SALPINGITIS Treatment for salpingitis Antibiotics-including intravenous administration of antibiotics Surgery - if the condition resists drug treatment. Complications of salpingitis Further infection - the infection may spread to nearby structures, such as the ovaries or uterus. Tubo -ovarian abscess ,Ectopic pregnancy, Infertility after

35. OOPHORITIS Isolated infection to the ovaries is a rarity. The ovaries are almost always affected during salpingitis [ salpingo-oophoritis ]. Direct affection of the ovaries without tubal involvement may be due to mumps or influenza. In mumps, there is no sterilizing effect on the ovaries unlike testes. The symptomatology and treatment are like those of salpingitis .  

36. STD BACTERIAL VIRAL PROTOZOAL ARTHROPODS FUNGAL

37. GONORRHEA Gonorrhea is a common infection that develops due to the bacterium Neisseria gonorrhoeae . It is highly contagious and, without treatment, can lead to life threatening complications Gonorrhea can spread during oral, vaginal, or anal sex. If a person touches an infected area of the body and then touches their eye, gonorrhea can also lead to pink eye. This infection can also spread to a baby during childbirth. There are often no symptoms, but if they do occur, they may include: pain during urination, discharge, swelling of the genitals, bleeding between periods, Rectal symptoms

38. GONORRHEA Diagnosis with the use of NAAT vulvovaginal or endocervical swab/violin string adhesions.   Treatment one dose of 3rd generation cephalosporin, specifically ceftriaxone 250 milligrams to be given by intramuscular injection. One dose of azithromycin 1 gram to be taken by mouth to treat possible coinfection of chlamydia .  After initial treatment, follow up tests should be discussed with the patient. 

39. SYPHILIS Syphilis stems from an infection with the bacterium Treponema pallidum.There are usually four stages. In the first stage, a person may notice a round, firm sore at the site of the infection, usually around the genitals, anus, rectum, or mouth .[chancre] At the secondary stage, there may be a non-itchy rash of rough, brownish or red spots on the palms of the hands or soles of the feet[ condyloma lata ] Lesions in the mucous membranes, such as the mouth, vagina, or anus Swollen lymph nodes, Hair loss, Headaches Weight loss, Muscle aches, Fatigue and fever

40. In the latent stage, the symptoms disappear, but the bacteria remain in the body and can continue to cause damage. Tertiary: presentation can be within months or years from inoculation. Systemic symptoms can range to cardiovascular, neurologic, and cutaneous symptoms described as gummatous lesions. Diagnosis will be guided by dark field microscopy [cork-screw shaped organism]and serologic tests [ VDRL,wesserman test,ELISA ] .

41. Treatment and management of secondary, latent, and tertiary syphilis should be independent on the treatment of primary syphilis infection.  Primary, secondary, and early syphilis infection can be treated with Penicillin G - Benzathine 2.4 million units to be given by intramuscular injection. Tertiary syphilis should be treated as an inpatient due to the three doses of penicillin G benzathine 2.4 million units once a week for a total of 3 weeks.

42. CHLAMYDIA It results from an infection with Chlamydia trachomatis . It is a common infection that can spread through anal, vaginal, and oral sex. It can also spread to a baby during childbirth[ prematurity,neonatal conjunctivitis]. Chlamydia does not usually cause any symptoms, but it can result in infertility and other complications if a person does not seek treatment for it. It is easy to cure with early treatment. If symptoms do occur, they may include a change in vaginal discharge and burning pain during urination.Chlamydia can also affect the rectum, this can lead to: rectal pain rectal bleeding rectal discharge Violin string adhesions

43. TREATMENT Primary treatment and management should be supported by history, the physical exam, and clinical presentation. Consideration of coinfections with the most common sexually transmitted infections should be considered and treated simultaneously. One dose of azithromycin 1 gram needs to be taken by mouth or doxycycline 100 milligrams to be taken by mouth for seven days After initial treatment, follow up tests should be discussed with the patient

44. CHANCROID Chancroid is a rare bacterial infection that develops due to Haemophilus ducreyi . It can only spread through sexual contact . It causes painful sores on the genitals. Chancroid can also increase the chance of HIV, and it can make HIV harder to treat. Painful, red-colored bumps in the genital region that become ulcerated, open sores. The base of the ulcer can appear grey or yellow. Urethritis , or inflammation of the urethra,Abnormal vaginal discharge Pain and bleeding of the sore

45. CHANCROID Dysuria , a condition caused by urethral inflammation Typically prescribe antibiotics to clear the infection. Azithromycin [1 gram (g) orally once daily] Ceftriaxone Ciprofloxacin

46. LYMPHOGRANULOMA VENEREUM (LGV) Lymphogranuloma venereum (LGV) is caused by one of the aggressive L serotypes of Chlamydia trachomatis usually acquired sexually Signs and symptoms: Patients will present with painful lymphadenopathy localized to the inguinal area. Patients may note the initial presentation of a pustule that gradually progressed to large painful ulceration Physical Exam: LGV presents with two stages:

47. LYMPHOGRANULOMA VENEREUM (LGV) Primary phase is a small painless papule/pustule that will ulcerate and can be visualized throughout the affected genital area. During the secondary phase, patients present with unilateral lymphadenopathy that is fluctuant with palpation or maybe suppurative in a presentation known as Buboes/groove sign. Buboes tend to rupture in the acute phase and progress to a thickened mass. Treatment - Doxycycline 100 milligrams taken by mouth twice daily for 21 day

48. TRICHOMONAS VAGINITIS Vaginal trichomoniasis is the most common and important cause of vaginitis in the childbearing period. Causative Organism: It is caused by Trichomonas vaginalis , Clinical Features There is sudden profuse and offensive vaginal discharge often dating from the last menstruation. Irritation and itching of varying degrees within and around the introitus are common. There is presence of urinary symptoms such as dysuria and frequency of micturition . There may be history of previous similar attacks

49. TRICHOMONAS VAGINITIS (a) There is thin, greenish-yellow and frothy offensive discharge per vagina (b) The vulva is inflamed with evidences of pruritus . Vaginal examination may be painful. The vaginal walls become red and inflamed with multiple punctate hemorrhagic spots. Diagnosis (a) Identification of the trichomonas is done by hanging drop preparation (b) Culture of the discharge collected

50. Treatment The treatment is very much effective with metronidazole . Metronidazole 200 mg thrice daily by mouth is to be given for 1 week. A single dose regimen of 2 g is an alternative. Tinidazole single 2 gm dose PO is equally effective. The husband should be given the same treatment schedule for 1 week. The husband should use condom during coitus irrespective of contraceptive practice until the wife is cured

51. GRANULOMA INGUINALE (DONOVANOSIS) The causative organism is a Gram-negative intracellular bacillu Calymmatobacterium granulomatis ( Donovania granulomatis). Signs and symptoms: Patients will present with highly vascularized lesions over the genitals, perineum that tend to be painless Physical Exam: Exam will show ulcer-like lesions that are beefy red consistent with high vascularization that bleeds easily with manipulation.

52. 4 main lesions can be seen on the exam: Ulcerovegetative : large painless ulcer present on the patients physical exam. (2) Nodular: soft and erythematous that tend to ulcerate throughout the infectious process. (3) Cicatricial : dry ulcerations that tend to transition into plaques. ( 4) Hypertrophic: lesions are thick and painless Treatment - Azithromycin 1 gram to be taken by mouth once per week until lesions resolve completely

53. HERPES GENITALIS The causative organism is herpes simplex virus (HSV) type 1 and 2. It is usually transmitted sexually by an infected partner but may possibly be transmitted by orogenital contact. HSV-1 usually affects the mouth. It can spread through saliva or if there is a herpes-related sore around another person’s mouth. It can pass to the genital area during oral sex.HSV-2 can affect the genital area, the anal area, and the mouth. It transmits through vaginal, oral, and anal sex.

54. HERPES GENITALIS The main symptoms are blisters around the mouth, anus, or genital area. These blisters can break, causing a painful sore that takes a week or longer to heal. Fever Body aches Swollen lymph nodes Painful urination Eye infection

55. HERPES GENITALIS Herpes cannot spread via utensils, toilet seats, swimming pools, soaps, or bedding. However, if a person touches a body part where herpes is present and then touches another part of their body, the herpes can spread to that There is currently no cure, but medication can help relieve any symptoms. Daily antiviral medications can help prevent the spread of herpes. Acyclovir, valacyclovir , and famciclovir are three types of primary treatment that can be started on patients.

56. Genital Warts (CONDYLOMA ACUMINATA) Condylomata are papillary lesions caused by Human Papilloma Virus (HPV) usually type 6 and 11 Treatment: HPV vaccine (Types 6 and 11) can prevent 90% of condyloma . Different treatment modalities used are: Cryotherapy , electrocautery , laser therapy, surgical excision or topical use of 5-fluorouracil, trichloro -acetic acid or intralesional interferon.

57. MOLLUSCUM CONTAGIOSUM It is a common and contagious viral skin infection. It causes raised, pearl-like nodules or papules on the skin. These papules are called molluscum bodies, Mollusca , or condyloma subcutaneum . The papules appear as small, firm, flesh-colored, dome-shaped, pearly, wart-like spots on the skin. The papules are generally painless, and they do not itch. They can affect any area of skin, but especially the trunk of the body, arms, and legs. Treatment options include: Curettage Cryotherapy , Laser therapy, Chemical treatment

58. PEDICULOSIS PUBIS The infective agent is a crab louse ( Phthirus pubis) which affects the coarse hair of the pubis. The louse along with its eggs are attached to the hair. It is transmitted by sexual contact or infected clothes encouraged by inadequate hygiene. It produces intense pruritis → scratching → secondary infection →suppuration Treatment Permethrin cream (1%) is applied over the affected area and washed off after 10 minutes. Lindane 1% is used as a shampoo

59. SCABIES This is caused by Sarcoptes scabiei . It produces intense itching and often excoriation of skin. It is often associated with poor local hygiene Treatment - Permethrin cream 5% or malathion 0.5% aguan solution is applied to all areas of the body below the neck and washed off after 8–14 hours. The clothing should be boiled. The family members are also to be treated simultaneously to prevent re-infection.

60. THANK YOU

61. Continued List of Organizations… American College of Rheumatology American Hospital Association American Pharmacists Association American Society of Clinical Oncology Arthritis Foundation Colorado Medical Society Medical Group Management Association Medical Society of the State of New York

62. Continued Organizations… Minnesota Medical Association North Carolina Medical Society Ohio State Medical Association Washington State Medical Association Adherence to these principles will ensure that patients have timely access to treatment and reduce administrative costs to the health care system.

63. Management Reform Principles The 21 principles are divided into five broad categories . Clinical validity Continuity of care Transparency and fairness Timely access and administrative efficiency Alternatives and exemptions

64. Clinical Validity

65. Clinical Validity – Principle #1 Health care providers want nothing more than to provide the most clinically appropriate care for each individual patient. Utilization management programs must therefore have a clinically accurate foundation for provider adherence to be feasible. Cost-containment provisions that do not have proper medical justification can put patient outcomes in jeopardy .

66. Clinical Validity – Principle #1 Summary Any utilization management program applied to a service, device or drug should be based on accurate and up-to-date clinical criteria and never cost alone. The referenced clinical information should be readily available to the prescribing/ordering provider and the public.

67. Clinical Validity – Principle #2 The most appropriate course of treatment for a given medical condition depends on the patient's unique clinical situation and the care plan developed by the provider in consultation with his/her patient. While a particular drug or therapy might generally be considered appropriate for a condition, the presence of comorbidities or patient intolerances, for example, may necessitate an alternative treatment. Failure to account for this can obstruct proper patient care

68. Clinical Validity – Principle #2 Summary Utilization Management program should allow for flexibility, including the timely overriding of step therapy requirements and appeal of prior authorization denials.

69. Clinical Validity – Principle #3 Adverse utilization management determinations can prevent access to care that a health care provider, in collaboration with his/her patient and the care team, has determined to be appropriate and medically necessary. As this essentially equates to the practice of medicine by the utilization review entity, it is imperative that these clinical decisions are made by providers who are at least as qualified as the prescribing/ordering provider.

70. Clinical Validity – Principle #3 Summary Utilization review entities should offer an appeals system for their utilization management programs that allows a prescribing/ordering provider direct access , such as a toll-free number, to a provider of the same training and specialty/subspecialty for discussion of medical necessity issues.

71. Continuity of Care

72. Continuity of Care – Principle #4 Patients forced to interrupt ongoing treatment due to health plan utilization management coverage restrictions could experience a negative impact on their care and health. In the event that, at the time of plan enrollment, a patient's condition is stabilized on a particular treatment that is subject to prior authorization or step therapy protocols, a utilization review entity should permit ongoing care to continue while any prior authorization approvals or step-therapy overrides are obtained.

73. Continuity of Care – Principle #4 Summary Utilization review entities should offer a minimum of a 60-day grace period for any step­ therapy or prior authorization protocols for patients who are already stabilized on a particular treatment upon enrollment in the plan. During this period, any medical treatment or drug regimen should not be interrupted while the utilization management requirements (e.g ., prior authorization, step therapy over rides, formulary exceptions, etc.) are addressed.

74. Continuity of Care – Principle #5 Many patients carefully review formularies and coverage restrictions prior to purchasing a health plan product in order to ensure they select coverage that best meets their medical and financial needs. Unanticipated changes to a formulary or coverage restriction throughout the plan year can negatively impact patients' access to needed medical care and unfairly reduce the value patients receive for their paid premiums.

75. Continuity of Care – Principle #5 Summary A drug or medical service that is removed from a plan's formulary or is subject to new coverage restrictions after the beneficiary enrollment period has ended should be covered without restrictions for the duration of the benefit year.

76. Continuity of Care – Principle #6 Many conditions require ongoing treatment plans that benefit from strict adherence. Recurring prior authorizations requirements can lead to gaps in care delivery and threaten a patient's health.

77. Continuity of Care – Principle #6 Summary A prior authorization approval should be valid for the duration of the prescribed/ordered course of treatment.

78. Continuity of Care – Principle #7 Many utilization review entities employ step therapy protocols, under which patients are required to first try and fail certain therapies before qualifying for coverage of other treatments. These programs can be particularly problematic for patients-such as those purchasing coverage on the individual marketplace-who change health insurance on an annual basis. Patients who change health plans are often required to disrupt their current treatment to retry previously failed therapeutic regimens to meet step therapy requirements for the new plan. Forcing patients to abandon effective treatment and repeat therapy that has already been proven ineffective under other plans' step therapy protocols delays care and may result in negative outcomes.

79. Continuity of Care – Principle #7 Summary No utilization review entity should require patients to repeat step therapy protocols or retry therapies failed under other benefit plans before qualifying for coverage of a current effective therapy.

80. Transparency and Fairness

81. Transparency & Fairness – Principle #8 Prior authorization requirements and drug formulary changes can have a direct impact on patient care by creating a delay or altering the course of treatment . In order to ensure that patients and health care providers are fully informed while purchasing a product and/or making care decisions, utilization review entities need to be transparent about all coverage and formulary restrictions and the supporting clinical documentation needed to meet utilization management requirements.

82. Transparency & Fairness – Principle #8 Summary Utilization review entities should publically disclose , in a searchable electronic format, patient-specific utilization management requirements , including prior authorization, step therapy, and formulary restrictions with patient cost-sharing information, applied to individual drugs and medical services. Such information should be accurate and current and include an effective date in order to be relied upon by providers and patients , including prospective patients engaged in the enrollment process. Additionally, utilization review entities should clearly communicate to prescribing/ordering providers what supporting documentation is needed to complete every prior authorization and step therapy override request.

83. Transparency & Fairness – Principle #9 Incorporation of accurate formulary data and prior authorization and step therapy requirements into electronic health records (EHRs) is critical to ensure that providers have the requisite information at the point of care. When prescription claims are rejected at the pharmacy due to unmet prior authorization requirements, treatment may be delayed or completely abandoned, and additional administrative burdens are imposed on prescribing providers and pharmacies/pharmacists.

84. Transparency & Fairness – Principle #9 Summary Utilization review entitles should provide and vendors should display accurate patient-specific and up-to-date formularies that include prior authorization and step therapy requirements in electronic health record (EHR) systems for purposes that include e-prescribing.

85. Transparency & Fairness – Principle #10 Data are critical to evaluating the effectiveness, potential impact and costs of prior authorization processes on patients, providers, health insurers and the system as a whole; however, limited data are currently made publically available for research and analysis. Utilization review entities need to provide industry stakeholders with relevant data, which should be used to improve efficiency and timely access to clinically appropriate care.

86. Transparency & Fairness – Principle #10 Summary Utilization review entities should make statistics regarding prior authorization approval and denial rates available on their website (or another publically available website) in a readily accessible format . The statistics shall include but are not limited to the following categories related to prior authorization requests: Healthcare provider type/specialty; Medication, diagnostic test or procedure; Indication; Total annual prior auth requests, approvals and denials; Reasons for denial such as, but not limited to, medical necessity or incomplete prior auth submission; and Denials overturned upon appeal These data should inform efforts to refine and improve utilization management programs

87. Transparency & Fairness – Principle #11 A planned course of treatment is the result of careful consideration and collaboration between patient and physician. A utilization review entity's denial of a drug or medical service requires deviation from this course. In order to promote provider (physician practice, hospital and pharmacy) and patient understanding and ensure appropriate clinical decision­ making, it is important that utilization review entities provide specific justification for prior authorization and step therapy override denials, indicate any covered alternative treatment and detail any available appeal options.

88. Transparency & Fairness – Principle #11 Summary Utilization review entities should provide detailed explanations for prior authorization or step therapy override denials , including an indication of any missing information. All utilization review denials should include the clinical rationale for the adverse determination (e.g ., national medical specialty society guidelines , peer-reviewed clinical literature , etc .), provide the plan's covered alternative treatment and detail the provider's appeal rights.

89. Timely Access and Administrative Efficiency

90. Timely Access and Efficiency – Principle #12 The use of standardized electronic prior authorization transactions saves patients, providers and utilization review entities significant time and resources and can speed up the care delivery process. In order to ensure that prior authorization is conducted efficiently for all stakeholders, utilization review entities need to complete all steps of utilization management processes through NCPDP SCRIPT ePA transactions for pharmacy benefits and the ASC X12N 278 Health Care Service Review Request for Review and Response transactions for medical services benefits. Proprietary health plan web-based portals do not represent efficient automation or true administrative simplification, as they require health care providers to manage unique logins/passwords for each plan and manually re-enter patient and clinical data into the portal.

91. Timely Access and Efficiency – Principle # 12 Summary A utilization review entity requiring health care providers to adhere to prior authorization protocols should accept and respond to prior authorization and step-therapy override requests exclusively through secure electronic transmissions using the standard electronic transactions for pharmacy and medical services benefits . Facsimile , proprietary payer web-based portals , telephone discussions and nonstandard electronic forms shall not be considered electronic transmissions.

92. Timely Access and Efficiency – Principle #13 Providers have encountered instances where utilization review entities deny payment for previously approved services or drugs based on criteria outside of the prior authorization review process (e.g., eligibility issues, medical policies, etc.). These unexpected payment denials create hardship for patients and additional administrative burdens for providers.

93. Timely Access and Efficiency – Principle # 13 Summary Eligibility and all other medical policy coverage determinations should be performed as part of the prior authorization process . Patients and physicians should be able to rely on an authorization as a commitment to coverage and payment of the corresponding claim.

94. Timely Access and Efficiency – Principle # 14 Significant time and resources are devoted to completing prior authorization requirements to ensure that the patient will have the requisite coverage. If utilization review entities choose to use such programs, they need to honor their determinations to avoid misleading and further burdening patients and health care providers. Prior authorization must remain valid and coverage must be guaranteed for a sufficient period of time to allow patients to access the prescribed care. This is particularly important for medical procedures, which often must be scheduled and approved for coverage significantly in advance of the treatment date.

95. Timely Access and Efficiency – Principle # 12 Summary In order to allow sufficient time for care delivery, a utilization review entity should not revoke , limit, condition or restrict coverage for authorized care provided within 45 business days from the date authorization was received.

96. Timely Access and Efficiency – Principle # 15 In order to ensure that patients have prompt access to care, utilization review entities need to make coverage determinations in a timely manner. Lengthy processing times for prior authorizations can delay necessary treatment, potentially creating pain and/or medical complications for patients.

97. Timely Access and Efficiency – Principle # 15 Summary If a utilization review entity requires prior authorization for non-urgent care , the entity should make a determination and notify the provider within 48 hours of obtaining all necessary information . For urgent care , the determination should be made within 24 hours of obtaining all necessary information.

98. Timely Access and Efficiency – Principle # 16 When patients receive an adverse determination for care, the patient (or the physician on behalf of the patient) has the right to appeal the decision. The utilization review entity has a responsibility to ensure that the appeals process is fair and timely.

99. Timely Access and Efficiency – Principle # 16 Summary Should a provider determine the need for an expedited appeal, a decision on such an appeal should be communicated by the utilization review entity to the provider and patient within 24 hours . Providers and patients should be notified of decisions on all other appeals within 10 calendar days. All appeal decisions should be made by a provider who (a) is of the same specialty , and subspecialty, whenever possible, as the prescribing/ordering provider and (b) was not involved in the initial adverse determination

100. Timely Access and Efficiency – Principle # 17 Prior authorization requires administrative steps in advance of the provision of medical care in order to ensure coverage. In emergency situations, a delay in care to complete administrative tasks related to prior authorization could have drastic medical consequences for patients.

101. Timely Access and Efficiency – Principle # 17 Summary Prior authorization should never be required for emergency care.

102. Timely Access and Efficiency – Principle #18 There is considerable variation between utilization review entities' prior authorization criteria and requirements and extensive use of proprietary forms. This lack of standardization is associated with significant administrative burdens for providers, who must identify and comply with each entity's unique requirements. Furthermore , any clinically based utilization management criteria should be similar-if not identical- across utilization review entities.

103. Timely Access and Efficiency – Principle # 18 Summary Utilization review entities are encouraged to standardize criteria across the industry to promote uniformity and reduce administrative burdens.

104. Alternatives and Exemptions

105. Alternatives and Exemptions – Principle #19 Broadly applied prior authorization programs impose significant administrative burdens on all health care providers, and for those providers with a clear history of appropriate resource utilization and high prior authorization approval rates, these burdens become especially unjustified.

106. Alternatives and Exemptions – Principle # 19 Summary Health plans should restrict utilization management programs to “outlier” providers whose prescribing or ordering patterns differ significantly from their peers after adjusting for patient mix and other relevant factors.

107. Alternatives and Exemptions – Principle #20 Prior authorization requirements are a burdensome way of confirming clinically appropriate care and managing utilization, adding administrative costs for all stakeholders across the health care system . Health plans should offer alternative, less costly options to serve the same functions.

108. Alternatives and Exemptions – Principle #20 Summary Health plans should offer provider/practices at least one physician-driven, clinically based alternative to prior authorization , such as but not limited to "gold-card" or "preferred provider" programs or attestation of use of appropriate use criteria , clinical decision support systems or clinical pathways.

109. Alternatives and Exemptions – Principle # 21 By sharing in the financial risk of resource allocation, providers engaged in new payment models are already incanted to contain unnecessary costs, thus rendering prior authorization unnecessary.

110. Alternatives and Exemptions – Principle # 21 Summary A provider that contracts with a health plan to participate in a financial risk-sharing payment plan should be exempt from prior authorization and step-therapy requirements for services covered under the plan's benefits.

111. Prior Authorization Legislative Bills SB 530 - Relating to Health Insurance – 2017 General Health Insurance : Requiring a utilization review entity or health insurer to make current prior authorization requirements , restrictions and forms accessible in a specified manner ; specifying requirements for a utilization review entity or health insurer that implements a new prior authorization requirement or that amends an existing requirement or restriction ; requiring a plan to publish on the plan's website and provide to an insured a written procedure for requesting a protocol exception, etc. Effective Date: July 1, 2017

112. Prior Authorization Legislative Bills HB 877 - Relating to Health Insurer Authorization – 2017 General Health Insurer Authorization : Revises criteria for prior authorization forms ; requires health insurers to provide manner, requirements, restrictions, & any changes to obtaining prior authorizations & protocol exceptions on its website & in writing; provides timeframe, conditions & notification requirements for health insurers to make determination for protocol exception requests. Effective Date : July 1, 2017

113. Prior Authorization/Fail-First Update HB 7117- Statewide Medicaid Managed Care Program The amendment added prior authorization and fail-first protocols. The bill was placed on Third Reading and will be heard again before it is voted on and heads back to the House.   A copy of the amended bill is here : http :1/ww w .flsenate . go v /Session/Bill/20 17/7117/Amendment/655868/PDF.

114. Contact Your State Representatives HEALTH POLICY Location: 530 Knott Building Mailing Address : 404 S.Monroe Street Tallahassee , FL 32399-1100 Chair : Senator Young Vice Chair : Senator Passidomo Members : Senators Benacquisto , Book, Hukill , Hutson , Montford and Powell [phone] Senate VOIP 5824 Staff Director : Sandra Stovall Committee Administrative Assistant : Celia Georgiades