What s New Medical Policy Updates September 2016

Transcription

1 What s New Medical Policy Updates September 2016 Listed below are the recent changes made to policies within the Geisinger Health Plan Medical Policy Portfolio during the month of August that will become effective October 15, 2016 (unless otherwise specified). The Plan uses medical policies as guidelines for coverage decisions made within the insured individuals written benefit documents. Coverage may vary by line of business and providers and members are encouraged to verify benefit questions regarding eligibility before applying the terms of the policy. MP24 External Counterpulsation REVISED (Edited Language) INDICATIONS: Disabling stable angina pectoris Coverage is provided for insured individuals members who have been diagnosed with disabling stable angina (Class III or above, [Canadian Cardiovascular Society Functional Classification (CCSC) or New York Heart Association (NYHA), see table 1] who, in the opinion of a cardiologist or cardiothoracic surgeon, are not readily amenable to candidates for surgical intervention, such as Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Graft (CABG) because of the following: (1). Their members condition is inoperable, or at high presents excessive risk of operative complications or post-operative failure. (2). Their members coronary anatomy is not readily amenable to does not lend itself to surgical intervention such procedures; or (3). They have Co-morbid conditions states which create introduce increased risk precluding surgical intervention excessive risk PROCESS: The insured individuals member must be evaluated by a cardiologist prior to initiation of therapy. MP53 Cochlear implant REVISED (Edited Language, Removed Healthy Connect, Edited Limitations) INDICATIONS: Single or multiple channel unilateral or bilateral cochlear implants will be considered medically necessary when ALL of the following criteria are met: The insured individual member must be at least 12 months of age with bilateral, moderate-to-profound sensorineural deafness (70 decibels or greater). The insured individual member must be unable to benefit from a hearing aid (open sentence recognition score of 40% or less under optimal aided circumstance) Service must be delivered by a participating provider The device must be an FDA approved cochlear implant. In addition, certain insured individuals members in the Medicare Business Segment may be eligible for cochlear implants as listed below : For Healthy Connect lines of Business Cochlear Implants are NOT COVERED for Healthy Connect lines of Business. LIMITATIONS:

2 Repair and/or replacement of processor will be covered under the applicable benefit document if implant met FDA guidelines, and to the extent not covered by the warranty. Replacement batteries and cables are not covered for most contracts. Replacement batteries and cables are covered with prior authorization only for GHP Family line of business. MP055 Mastectomy for Gynecomastia Oophorectomy REVISED (Edited Language) CRITERIA: For those product lines in which surgical treatment of male gynecomastia is not specifically excluded, the following criteria will be used to determine eligibility for coverage. All must be met: Male Member is of age 18 years or older or puberty is substantially completed Gynecomastia meets ASPS Grade II, III, or IV definition (see Definitions Section) MP057 Prophylactic Oophorectomy REVISED (Edited Language) Prophylactic oophorectomy is the removal of both ovaries for the potential benefit of preventing the development of ovarian cancer in women members who are at high risk for the disease. Current screening methods for ovarian cancer are not sensitive enough to detect early cancer. Because a high percentage of ovarian cancers are detected in advanced stages, long-term survival rates are significantly decreased. Because of the lack of an effective means of screening for ovarian cancer, prophylactic oophorectomy is considered as a treatment for women members at high risk for the disease. Women Members at risk include women those from families with hereditary cancer syndromes and women those with known BRCA1 or BRCA2 mutation. INDICATIONS: Prophylactic bilateral oophorectomy may be considered medically necessary in selected patients, with other risk factors including null parity, low parity, infertility, early menarche, late menopause, and late first pregnancy, who have ONE of the following criteria: 1. Women Members with a known BRCA1 or BRCA2 mutation confirmed by molecular susceptibility testing. 2. Women Members who have completed childbearing years (usually age 40 years) and has hereditary ovarian cancer syndrome based on a family pedigree constructed by a physician or genetic counselor competent in determining the presence of an autosomal dominant inheritance pattern. 3. Women Members with a personal history of breast cancer and at least one 1st degree relative (e.g., mother, sister, daughter) with history of ovarian cancer. 4. Women Members with two 1st degree relatives (e.g., mother, sister, daughter) with a history of ovarian cancer. 5. Women Members with one 1st degree relative (e.g., mother, sister, daughter) and one or more 2nd degree relatives (maternal or paternal aunt or grandmother) with ovarian cancer. LIMITATIONS: Prophylactic oophorectomy is medically necessary ONLY for those women members with unique clinical circumstances outlined under INDICATIONS.

3 MP59 Fetal Surgery REVISED (Edited Indications) INDICATIONS: REQUIRES PRIOR MEDICAL DIRECTOR OR DESIGNEE AUTHORIZATION The Plan will cover fetal surgery for the following indications: Congenital cystic adenomatoid malformations Urinary tract obstruction Hydronephrosis Acardiac twins High risk sacrococcygeal teratomas (SCT) Twin reversed arterial perfusion Fetal cord ligation for twin to twin transfusion* *only in the event of 100% predicted infant mortality without intervention MP068 Reduction mammoplasty REVISED (Edited Language) LIMITATIONS: For insured individuals members enrolled in product lines in which reduction mammaplasty is not specifically excluded, Prior Authorization by a Medical Director or designee is Required. CRITERIA: For those insured individuals members enrolled in product lines in which reduction mammaplasty is not specifically excluded, the following criteria will be used to determine eligibility for coverage. a b Physician provided documentation of a diagnosis of macromastia; and Documented chronic pain due to macromastia defined by all of the following criteria Pain that affects the activities of daily living for a minimum of 6 months Pain is documented in the medical record to involve Upper back and/or Neck/shoulders Ulceration or pain/grooving from cutting of bra straps and c For females members 40 years of age or older, a mammogram that was negative for cancer has been completed within the year prior to the planned reduction mammaplasty; MP71 Subcutaneous Glucose Monitor REVISED (Edited Language) I. Personal continuous subcutaneous glucose monitor may be considered for pediatric and adult insured individuals members with Type 1 diabetes who meet all of the following criteria: 1. Documentation of three (3) months active participation in either the Plan Diabetes Management program or an American Diabetes Association recognized program with continuing diabetes education ; AND Documentation of a vendor certificate of medical necessity with physician signature without previous supporting documentation in the medical record is not sufficient to meet criteria for coverage. AUTHORIZATION DETERMINATION Long-term use of continuous glucose monitoring devices will be initially provided for a three month time period. Insured individuals Members authorized to receive longterm use of continuous glucose monitoring devices must be followed by a Plan disease management or

4 medical home case manager. At the end of the first three months, Health Plan staff will review compliance and health outcomes data provided by the ordering physician. Non-compliance or lack of improvement in glycemic control will result in medical director review to determine continued medical necessity. Extenuating circumstances that affect compliance will be taken into consideration. MP078 Sexual Dysfunction REVISED (Edited Language) THERAPIES: Medications: Medications for the treatment of erectile dysfunction are excluded and NOT COVERED for all lines of business unless specifically addressed in the applicable benefit document. For insured individuals members with contracts that do not exclude these medications, coverage is subject to existence of a pharmacy benefit, and to the terms of the insured individuals pharmacy benefit plan. Patient administered medications for the treatment of impotence are administered by the Geisinger Health Plan Pharmacy Department. Applicable co-payments and/or deductibles also apply per the insured individuals pharmacy benefit plan. External Devices: Coverage is subject to the terms, limitations and/or exclusions specific to the insured individuals benefit document or applicable rider. Commercial group and non-group: services, devices and equipment related to sexual dysfunction, male or female, are excluded and are NOT COVERED per the applicable benefit document section titled Exclusions. For insured individuals members with contracts that do not exclude such devices, external penile vacuum constriction devices may be covered when prescribed by a Plan physician as an alternative to other therapies for the treatment of impotence. Implantable Devices: Commercial group and non-group: implantable devices related to sexual dysfunction or sexual transformation, male or female, are excluded and are NOT COVERED per the applicable benefit document section titled Exclusions. For insured individuals with contracts that do not exclude implantable devices for the treatment of sexual dysfunction, coverage is subject to the terms, limitations and/or exclusions specific to the insured individuals benefit document. When not specifically excluded, surgically implantable inflatable or non-inflatable penile prosthetic devices are considered medically necessary when: Impotence is organic in nature; and The member has failed other treatment options, or other treatment options are contraindicated, including but not limited to injections or vacuum pump. Surgical repair, removal and/or replacement may be necessary due to malfunction of the prosthesis or patient complications. Unless excluded by benefit contract, these services are considered medically necessary and are covered. EXCLUSIONS: For group and non-group insured individuals, sexual dysfunction services, devices and equipment, male or female, are excluded and are not covered per the applicable benefit document section titled Exclusions unless explicitly provided under the terms of a Rider and listed on the current face sheet. Female erectile Clitoral stimulation devices (e.g., Eros clitoral stimulation device). There is insufficient peer reviewed literature to support the efficacy of this treatment at this time. The device is considered investigational and is NOT COVERED.

5 Penile revascularization surgery is considered investigational and is NOT COVERED. There is insufficient evidence in the published, peer-reviewed medical literature to support the safety and efficacy of this procedure. Surgically implanted penile prosthetic devices for the treatment of psychogenic erectile dysfunction is considered not medically necessary and is NOT COVERED Sexual Transformation Transplants, implants, procedures, services and supplies related to sex transformation are NOT COVERED. MP104 Subcutaneous Insulin Pump REVISED (Edited Language) CRITERA FOR COVERAGE: REQUIRES PRIOR MEDICAL DIRECTOR OR DESIGNEE AUTHORIZATION Insulin infusion pumps will be considered to be medically necessary in Type I and Type 2 diabetics when the following criteria are met: Physician provided documentation of: The insured individual member is treated with multiple daily injections of insulin (i.e. at least 3 injections per day), with frequent self-adjustments of insulin dose for at least 6 months prior to initiation of the insulin pump Sensor-augmented insulin pump therapy with the low glucose threshold suspend Sensor-augmented insulin pump therapy with the low glucose threshold suspend will be considered for coverage for coverage in insured individuals member 16 years and older with Type 1 diabetes when the current criteria for both external insulin pumps and the additional criteria for continuous glucose monitors listed below have been met: EXCLUSIONS: Sensor augmented insulin pump therapy with the low glucose threshold suspend feature is considered investigational in insured individuals member younger than 16 years. Replacement of a currently functioning Continuous Subcutaneous Insulin Infusion pumps for the sole purpose of expired warranty, upgrade in model or use with a non-covered monitoring device is not considered medically necessary. Replacement due to slight damage to the pump without causing the pump to malfunction is also considered not medically necessary. Equipment failure requires detailed documentation and must include the pump serial number. The vendor must provide the insured individual s member s equipment serial number with request for repair or replacement. MP121 Automated External Defibrillators REVISED (Edited Language) The Plan considers a wearable cardioverter defibrillator (e.g. LifeVest) as medically necessary when the following criteria are met: 1. The insured individual member must be under the care of, and the device be recommended by a cardiologist sub-specializing in electrophysiology ; and 2. The insured individuals member must meet criteria A; or criteria B or criteria C; Criteria A) Implanted cardiac defibrillator surgery is medically contraindicated, such as those awaiting a heart transplantation, awaiting ICD reimplantation following infection-related removal, or patients with a systemic infection process or other temporary condition that

6 precludes implantation and the insured individual member has one of the following conditions: Criteria C) As a bridge to ICD implantation when the following criteria are met: 1. Following myocardial infarction (MI) with a history of ventricular tachycardia or ventricular fibrillation after the first 48 hours, or 2. For insured individuals members with a left ventricular ejection fraction less than or equal to 40. * Transient or reversible causes include conditions such as, but not limited to drug toxicity, severe hypoxia, acidosis, hypokalemia, hyperkalemia, hypercalcemia, systemic infection and active myocarditis. ** Myocardial infarction must be documented by elevated cardiac enzymes or q-waves on an electrocardiogram. Ejection fraction must be measured by angiography, radionuclide scanning or echocardiography LIMITATIONS: For lines of business with Durable Medical Equipment benefit, coverage will be subject to the limitations or exclusions expressed in the applicable benefit document. EXCLUSIONS: Insured individuals Members must not have: MP148 Ambulatory Cardiac Event Monitors REVISED (Edited Language, Limitations, Exclusions) Mobile Cardiac Outpatient Telemetry (MCOT): may be considered medically necessary when all of the following criteria are met: The study is ordered by a cardiologist; and There is a low likelihood of a potentially life-threatening cardiac event; and Other testing/monitoring has been unrevealing or is inappropriate; and It is anticipated that the results would provide diagnostic and treatment information; and The insured individual s member s condition is demonstrated by one of the following categories: a. The insured individual member requires monitoring for known, non-life threatening arrhythmias such as atrial fibrillation, other paroxysmal supraventricular arrhythmias, evaluation of various bradyarrhythmias, and intermittent bundle branch block; or b. The insured individual member is recovering from coronary artery bypass graft surgery or valve replacement surgery and has a documented atrial arrhythmia; or c. The insured individual member has symptomatic underlying cardiac structural disease; or d. The insured individual member has no structural heart disease but has recurrent severe symptoms (i.e., recurrent syncope), and in whom all testing is negative and an implantable event recorder is contemplated; or e. The insured individual member has uncontrolled atrial fibrillation post-pneumonectomy. CONTRAINDICATION: MCOT is contraindicated for use in individuals at high risk for developing sustained ventricular tachycardia or ventricular fibrillation characterized by any of the following: a. a history of sustained ventricular tachycardia or a documented occurrence of ventricular fibrillation; or b. a measured ejection fraction of less than 30% with a widened QRS interval; or c. unstable angina defined as chest pain at rest, a new onset of angina, or a change in existing patterns of angina; or d. insured individuals who are candidates for heart valve surgery; or e. insured individual Members with moderate to severe symptoms ( i.e., syncope or near syncope) with underlying structural heart disease and a high likelihood of serious arrhythmias; or

7 f. insured individual Members who would be more appropriately cared for in a hospital setting LIMITATIONS: A course of treatment will be defined as up to consecutive days. A monitoring episode up to consecutive days will be considered as one unit. Monitoring will be limited to no more than two episodes in a twelve month period. Concomitant use of cardiac surveillance, Holter monitoring and/or event monitoring is not medically necessary. EXCLUSIONS: MCOT is considered experimental, investigational and unproven when used as a screening tool, and is NOT COVERED. MCOT in excess of one unit (one to consecutive days) is NOT COVERED. MP166 MR Ultrasound ablation for Uterine Fibroids REVISED (Edited Language) Uterine fibroids (leiomyomata) are benign tumors commonly found in women in their during the reproductive years. Magnetic Resonance Focused Ultrasound therapy is a non-invasive treatment that proposes to treat symptomatic fibroids by applying a precise ultrasound beam to the tumor causing tissue destruction by thermal injury, while preserving adjacent structures. This procedure can be done as an outpatient in an MRI suite with no anesthesia or conscious sedation. One system, Exblate 2000, has received marketing approval from the Food and Drug Administration. MP170 Gene Expression Testing for Breast cancer REVISED (Edited Language) *Women Members with micrometastases (isolated tumor cells in the lymph node) are considered to be node negative Prosigna Breast Cancer Assay: The Plan considers Prosigna Breast Cancer Assay gene expression profiling for breast cancer treatment as medically necessary to assess the need for adjuvant chemotherapy in newly diagnosed breast cancer when ALL of the following are met: Diagnosed with Stage I or II breast cancer within the previous 6 months; and Node negative* or Stage II with 1-3 positive nodes; and Estrogen receptor (ER) positive tumor; and Her2 negative tumor; and The insured individual would be a candidate for adjuvant chemotherapy (i.e., chemotherapy is not contraindicated due to other factors); and The result of the test will guide the decision whether or not to use chemotherapy; and The insured individual would choose to receive chemotherapy if offered. *Women Members with micrometastases (isolated tumor cells in the lymph node) are considered to be node negative For Medicare and Medicaid Business Segments: Palmetto GBA, the designated national contractor for its Oncotype DX breast cancer test, has expanded its coverage policy for all qualified Medicare patients to include patients with ductal carcinoma in situ (DCIS). LIMITATIONS:

8 The test is covered once per primary tumor, per individual. For the Medicare and Medicaid Business Segments CMS directives allow MammaPrint 70 gene assay to be considered for coverage when used to predict recurrence risk in women members with ERpositive or ER-negative, lymph node-negative breast cancer. Palmetto GBA established a formal coverage policy for all Medicare patients. This local carrier determination is applicable nationally. MP201 Obstructive Sleep Apnea REVISED (Added Exclusion) The Plan does not provide coverage for ANY of the following procedures or services for the treatment of OSA because they are considered experimental, investigational or unproven: (This list may not be all inclusive): Radiofrequency Volumetric Tissue Reduction (Somnoplasty ) (See Also MP40 Somnoplasty/Coblation) Coblation (See Also MP40 Somnoplasty/Coblation) Cautery-assisted Palatal Stiffening Operation (CAPSO) Pillar Palatal Implant System Repose Bone Screw System Injection Snoreplasty Flexible Positive Airway Pressure Hypoglossal nerve stimulation MP210 Endometrial Ablation REVISED (Edited Language) Endometrial ablation is the removal or destruction of the endometrium (lining of the uterus). Endometrial ablation is an alternative to hysterectomy for women members with heavy uterine bleeding who wish to avoid hysterectomy. INDICATIONS: Endometrial ablation may be considered medically necessary in females members who meet the following criteria: Profuse menorrhagia such that the individual would be a candidate for hysterectomy, that is unresponsive to (or a contraindication/intolerance exists for) either: MP228 HPV DNA testing REVISED (Edited Language) INDICATIONS: 1. The assessment of women members at any age when a Pap smear detects: Atypical squamous cells of undetermined significance (ASCUS); or Low-grade squamous intraepithelial (LSIL) cells 2. As a cervical cancer screening option when used in combination with a Pap smear or liquid-based cytology in women members aged 30 years and older. EXCLUSIONS: Use as a primary (stand alone) screening test for cervical cancer Use as a primary screening test option in women members younger than 30 years of age Use when positive cervical cytology has been definitively identified MP244 Pelvic Floor Stimulation REVISED (Edited Language)

9 EXCLUSIONS: The Plan does not cover pelvic floor stimulation for the treatment of incontinence unless required by state or federal mandate. Outcomes evidence from multiple randomized, controlled trials have not found that electrical pelvic floor stimulation used to treat urinary incontinence in women consistently improved net health outcome compared with placebo or other conservative treatments, nor did it support the efficacy of this treatment in members men with post-prostatectomy incontinence. It is considered experimental, investigational or unproven and therefore, NOT COVERED. MP265 Proteomic Serum Analysis REVISED (Edited Language) OVA1 (Vermillion, Inc) is a blood test to help assess the likelihood an ovarian mass is malignant prior to a planned surgery. In conjunction with clinical evaluation of women members age 18 and older who have an ovarian mass and planned surgery, OVA1 may help triage according to probability of malignancy. OVA1 measures the levels of five proteins found in the blood and then uses a proprietary software to calculate a single score. Risk is measured using a 0-10 scale versus predetermined cut-off points. Women Members who are pre-menopausal have a cut off of 5.0 whereas postmenopausal women members have a 4.4 cutoff. Medicare Business Segment: In compliance with Novitas LCD (L35396) the OVA1 proteomic assay will be covered according to the FDA label. OVA1 is intended only for members women, 18 years and older, who are already selected for surgery because of their pelvic mass. It is not intended for ovarian cancer screening or for a definitive diagnosis of ovarian cancer MP272 PCA3 Progensa REVISED (Edited Language) Prostate cancer antigen 3 (PCA3, also referred to as DD3) is a gene that expresses a non-coding RNA. PCA3 is only expressed in human prostate tissue, and the gene is highly overexpressed in prostate cancer. Because of its restricted expression profile, the PCA3 RNA is thought to be useful as a tumor marker. The PROGENSA PCA3 Assay is an automated molecular assay that helps physicians determine the need for repeat prostate biopsies in men members who have had a previous negative biopsy. MEDICARE BUSINESS SEGMENT: The PROGENSA PCA3 Assay is covered for insured individuals to help determine the need for repeat prostate biopsies in men members who have had a previous negative biopsy. EXCLUSIONS: The Geisinger Technology Assessment Committee determined that at the present time, there is insufficient evidence in the peer-reviewed, published medical literature to support the use of PCA3 assay to determine the need for repeat biopsy in men members who have had a previous negative prostate biopsy. Unless mandated by state or federal regulation, this testing is currently considered to be experimental, investigational or unproven, and therefore NOT COVERED. MP282 Termination of Pregnancy REVISED (Edited Language) INDICATIONS: REQUIRES PRIOR AUTHORIZATION BY A PLAN MEDICAL DIRECTOR Termination of pregnancy may be considered only for the following indications:

10 1. The mother s member s life is in danger due to a condition, illness, or injury, and medical documentation is submitted to support an abortion being necessary to avert the death of the insured individual; or 2. The insured individual member is an alleged victim of rape or incest and physician certification attests that a). the alleged rape or incest was reported to law enforcement or child protective services: or b). the insured individual member was physically or psychologically unable to report the crime MP306 Tumor Treatment Fields REVISED (Added Exclusion) For the Medicaid business segment, the use of TTF devices for cancer treatment is considered experimental/investigational and NOT COVERED per MCOPS Memo #06/ MP308 Wireless Pulmonary Artery Pressure Monitoring REVISED (New Policy) This technology consists of a sensor implanted in the distal pulmonary artery, a transvenous delivery system, and an electronic processor that transmits pulmonary artery pressure measurements from the implanted sensor to a secure database. This technology includes, but is not limited to, the CardioMEMS Champion Heart Failure Monitoring System, the ImPressure device, and the Chronicle implantable continuous hemodynamic monitoring device, EXCLUSIONS: The Plan does NOT provide coverage for Wireless Pulmonary Artery Pressure Monitoring because it is considered experimental, investigational or unproven. The Geisinger Technology Assessment Committee evaluated this technology and concluded that there is insufficient evidence in the peer-reviewed published medical literature to establish the effectiveness of this test on health outcomes when compared to established tests or technologies. Note: A complete description of the process by which a given technology or service is evaluated and determined to be experimental, investigational or unproven is outlined in MP 15 - Experimental Investigational or Unproven Services or Treatment. The following policies have been reviewed with no change to the policy section. Additional references or background information was added to support the current policy. MP039 Home Uterine Monitor MP63 Acupuncture MP102 Morphometric Tumor Analysis MP106 Routine Ultrasonography in Uncomplicated Pregnancy MP115 Autologous Chondrocyte Implant MP130 Ambulatory BP Monitor MP163 Thermography MP183 Cranial Electrotherapy Stimulation MP185 Chemosensitivity and Chemoresistance Assays MP200 Osteochondral Autograft Transplant MP202 Interferential Stimulation MP206 Electrocardiographic Body Surface Mapping

11 MP208 Selective Internal Radiation Therapy MP221 Suprachoroidal Delivery of Pharmacologic Agents MP234 Occipital Nerve Stimulation MP246 Multigene Expression Assay for predicting Recurrence in Colon Cancer MP267 Amniotic Membrane Transplantation MP291 TX1 Tissue Removal System for Ablating and Removing Tissue