Blues highlight medical, benefit policy changes

95800

Basic benefit and medical policy
This unattended sleep study procedure may be covered for patients who have a high pretest probability of obstructive sleep apnea, effective Feb. 1, 2015
 
Group variations
Ford, Chrysler and URMBT members are excluded.

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The criteria for the Liver Transplant Policy have been updated. This policy is effective July 1, 2015.

The safety and effectiveness of liver transplantation and retransplantation have been established. It may be considered a useful therapeutic procedure in carefully selected patients with end-stage liver failure due to irreversibly damaged livers.

Note: Liver transplants (cadaver or living-donor) are covered for the indications listed below when adolescents or adults have met the requesting transplanting center’s selection criteria and one of the following.

• Model of end-stage liver disease score greater than 10
• Approval for transplant received from the United Network for Organ Sharing Regional Review Board

Inclusions for liver transplant:
Patients with end-stage liver disease. Etiologies of end-stage liver disease include, but are not limited to, the following:
Hepatocellular diseases

• Alcoholic liver disease
• Viral hepatitis (either A, B, C or non-A, non-B)
• Autoimmune hepatitis
• Alpha-1 antitrypsin deficiency
• Hemochromatosis
• Non-alcoholic steatohepatitis
• Protoporphyria
• Wilson's disease

Cholestatic liver diseases

• Primary biliary cirrhosis
• Primary sclerosing cholangitis with development of secondary biliary cirrhosis
• Biliary atresia

Vascular disease

• Budd-Chiari syndrome

Neuroendocrine tumors metastatic to the liver (See NET criteria below.***)
Primary hepatocellular carcinoma
Inborn errors of metabolism
Trauma and toxic reactions
Miscellaneous indications

• Familial amyloid polyneuropathy

Patients with polycystic disease of the liver who have massive hepatomegaly causing obstruction or functional impairment.
Pediatric patients with nonmetastatic hepatoblastoma
Patients with unresectable hilar cholangiocarcinoma if additional inclusionary criteria are met (For more information, visit
http://optn.transplant.hrsa.gov/ContentDocuments/OPTN_Policies.pdf#nameddest=Policy_08)

According to the OPTN policy on liver allocation, candidates with cholangiocarcinoma meeting the following criteria will be eligible for a MELD/PELD exception with a 10 percent mortality equivalent increase every three months:

• Centers must submit a written protocol for patient care to the OPTN/UNOS Liver and Intestinal Organ Transplantation Committee before requesting a MELD score exception for a candidate with CCA. This protocol should include selection criteria, administration of neoadjuvant therapy before transplantation, and operative staging to exclude patients with regional hepatic lymph node metastases, intrahepatic metastases, and/or extrahepatic disease. The protocol should include data collection as deemed necessary by the OPTN/UNOS Liver and Intestinal Organ Transplantation Committee.
• Candidates must satisfy diagnostic criteria for hilar CCA: malignant-appearing stricture on cholangiography and one of the following: carbohydrate antigen 19-9 100 U/mL, or and biopsy or cytology results demonstrating malignancy, or aneuploidy. The tumor should be considered unresectable on the basis of technical considerations or underlying liver disease (e.g., primary sclerosing cholangitis).
• If cross-sectional imaging studies (computed tomography [CT] scan, ultrasound, magnetic resonance imaging [MRI]) demonstrate a mass, the mass should be 3 cm or less.
• Intra- and extrahepatic metastases should be excluded by cross-sectional imaging studies of the chest and abdomen at the time of initial exception and every 3 months before score increases.
• Regional hepatic lymph node involvement and peritoneal metastases should be assessed by operative staging after completion of neoadjuvant therapy and before liver transplantation. Endoscopic ultrasound-guided aspiration of regional hepatic lymph nodes may be advisable to exclude patients with obvious metastases before neoadjuvant therapy is initiated.
• Transperitoneal aspiration or biopsy of the primary tumor (either by endoscopic ultrasound, operative, or percutaneous approaches) should be avoided because of the high risk of tumor seeding associated with these procedures.

***Criteria for liver transplant patient selection for neuroendocrine tumors metastatic to the liver (MELD exception applications for patients with NET):
-Recipient age <60 years
-Resection of primary malignancy and extra-hepatic disease without any evidence of recurrence at least six months prior to MELD exception request.
-Liver-limited Neuroendocrine Liver Metastasis (NLM), Bi-lobar, not amenable to resection. Tumors in the liver should meet the following radiographic characteristics:
CT scan: Triple phase contrast

• Lesions may be seen on only one of the three phases
• Arterial phase: may demonstrate a strong enhancement
• Large lesions can become necrotic/calcified

MRI appearance:

• Liver metastasis are hypodense on T1 and hypervascular in T2 wave images
• Diffusion restriction
• Majority of lesions are hypervascular on arterial phase with wash-out during portal venous phase IV. Hepatobiliary phase post Gadoxetate Disodium (Eovist): Hypointense lesions are characteristics of NET

-Consider for exception only those with a NET of gastro-entero-pancreatic origin tumors with portal system drainage. Note: Neuroendocrine tumors whose primary is located in the lower rectum, esophagus, lung, adrenal gland and thyroid are not candidates for automatic MELD exception.
-Lower to intermediate grade following the WHO classification. Only well-differentiated (Low grade, G1) and moderately differentiated (intermediate grade G2). Mitotic rate <20 per 10 HPF with less than 20 percent ki-67 positive markers.
-Tumor metastatic replacement should not exceed 50 percent of the total liver volume
-Negative metastatic workup should include one of the following:

• Positron emission tomography (PET scan
• Somatostatin receptor scintigraphy
• Gallium-68 (68Ga) labeled somatostatin analogue 1,4,7,10-tetraazacyclododedcane-N, N′, N″,N′″-tetraacetic acid (DOTA)-D-Phe1-Try3–octreotide (DOTATOC), or other scintigraphy to rule out extra-hepatic disease, especially bone metastasis.

Note: Exploratory laparotomy or laparoscopy is not required prior to MELD exception request.

-No evidence for extra-hepatic tumor recurrence based on metastatic radiologic workup at least three months prior to MELD exception request (submit date).
-Recheck metastatic workup every three months for MELD exception increase consideration by the Regional Review Board. Occurrence of extra-hepatic progression – for instance lymph-nodal Ga68 positive locations – should indicate de-listing. Patients may come back to the list if any extra-hepatic disease is zeroed and remained so for at least six months.
-Presence of extra-hepatic solid organ metastases (e.g., lungs, bones) should be a permanent exclusion criteria.

Exclusions for liver transplant

• Patients with intrahepatic cholangiocarcinoma
• Patients with hepatocellular carcinoma that has extended beyond the liver
• Patients with ongoing alcohol or drug abuse. (Evidence for abstinence may vary among liver transplant programs, but generally, a minimum of three months is required.)
• Patients with conditions not included in the inclusions section.

Inclusions for liver retransplant:
Liver retransplant is established for patients with:

• Primary graft non-function
• Hepatic artery thrombosis
• Chronic rejection
• Ischemic type biliary lesions after donation after cardiac death
• Recurrent non-neoplastic disease causing late graft failure

Exclusions for liver retransplant
Patients not meeting above inclusionary criteria for retransplant.

Potential contraindications for transplant or retransplant

Note: Final patient eligibility for transplant is subject to the judgment and discretion of the requesting transplant center.

Potential contraindications represent situations where proceeding with transplant is not advisable in the context of limited organ availability. Contraindications may evolve over time as transplant experience grows in the medical community. Clinical documentation supplied to the health plan should demonstrate that attending staff at the transplant center have considered all contraindications as part of their overall evaluation of potential organ transplant recipients and have decidedto proceed.

• Known current malignancy, including metastatic cancer
• Recent malignancy with high risk of recurrence
• Untreated systemic infection making immunosuppression unsafe, including chronic infection
• Other irreversible end-stage disease not attributed to liver disease
• History of cancer with a moderate risk of recurrence
• Systemic disease that could be exacerbated by immunosuppression
• Psychosocial conditions or chemical dependency affecting ability to adhere to therapy

64566

Basic benefit and medical policy
The safety and effectiveness of posterior tibial nerve stimulation for urinary dysfunction have been established. It may be considered a useful therapeutic option when indicated. The exclusionary criteria have been updated, effective July 1, 2015.

Inclusionary guidelines
Posterior tibial nerve stimulation is established in patients who meet all of the following criteria:

• There is a diagnosis of urinary frequency, nocturia
  or urinary urgency. Active urinary tract infections
  and anatomical abnormalities of the lower urinary
  tract have been excluded as a cause of urinary
  dysfunction.
• The patient has tried and failed conservative
  behavioral therapies (e.g. biofeedback, fluid
  management, pelvic floor exercises) for at least a
  sufficient duration to fully assess their efficacy.
•    There is documented failure or intolerance of
  pharmacologic treatment (anti-cholinergic drugs or a
  combination of an anti-cholinergic and a tricyclic
  anti-depressant).
• PTNS treatment consists of 30-minute weekly
  sessions for 12 treatments.
• For continuation of treatment, patients must report
  an improvement in symptoms of urinary frequency,
  nocturia or urinary urgency within the initial six
  weeks (six sessions) of PTNS treatment.
• After weekly 12 sessions, treatments may continue
  at a frequency of one per month, up to a total of two
  years. The two-year time period begins with the
  initiation of PTNS treatment.

Exclusionary guidelines

• PTNS is not established for all other indications, including stress and neurogenic incontinence.
• PTNS has not been established for fecal incontinence
• PTNS should be discontinued if symptoms do not improve within the initial 6 treatment sessions
• PTNS treatment beyond 2 years has not been extensively studied and is therefore not established for long-term use.

90651

Basic benefit and medical policy
The safety and effectiveness of Gardasil®9 have been established, effective Jan. 1, 2015.

The Advisory Committee on Immunization Practices recommends that routine HPV vaccination be initiated at age 11 or 12. The vaccination series can be started beginning at age 9. Vaccination is recommended for females and males ages 13 through 18 who have not been previously vaccinated or who have not completed the full series.

HPV2, HPV4 and HPV9 are each administered in a three-dose schedule. The second dose is administered at least one to two months after the first dose and the third dose at least six months after the first dose.

Note: If vaccination providers do not know or do not have available the HPV vaccine product previously administered or are in clinical settings transitioning to HPV9 for protection against HPV 16 and 18, any available HPV vaccine product may be used to continue or complete the series for females. HPV9 or HPV4 may be used to continue or complete the series for males.

Group variations
Refer to member’s policy for coverage status

0392T, 0393T

Basic benefit and medical policy
Magnetic esophageal ring insertion for the treatment of gastroesophageal reflux, or GERD, is experimental. The use of this device has not been scientifically shown to improve patient clinical outcomes.

Removal of an implanted magnetic esophageal ring device may be considered established for patients who experience side effects or complications of the device of such severity as to disrupt the patient’s normal quality of life.

This policy has been updated, effective July 1, 2015.

Inclusionary guidelines
Inclusions are for the removal of the magnetic esophageal ring device only.

Must have documentation in the medical record of complications of the implanted device, including, but not limited to:

• Ring erosion
• Ring migration
• Infection
• Severe dysphagia

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Experimental:
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Basic benefit and medical policy
The criteria for the autografts and allografts in the treatment of focal articular cartilage lesions policy have been updated. This policy is effective July 1, 2015.

The safety and effectiveness of osteochondral allografting and autografting for defects of the knee have been established. It is a useful therapeutic option for patients meeting specific patient selection criteria.

Osteochondral allografting:
The safety and effectiveness of osteochondral allografting to repair large (e.g., 10cm2), full-thickness chondral defect of the knee caused by acute or repetitive trauma have been established. It is a useful therapeutic option for select patients.

Osteochondral allografting for all other joints (other than the knee) is experimental. It has not been shown to improve patient outcomes better than conventional treatment.

Osteochondral autografting:
The safety and effectiveness of osteochondral autografting, using one or more cores of osteochondral tissue, has been established for the treatment of symptomatic full-thickness cartilage defects of the knee caused by acute or repetitive trauma in patients who have had an inadequate response to a prior surgical procedure, when the inclusionary criteria are met.

Osteochondral autografting for all other joints, including talar, and any indications other than those listed above, is considered experimental.

Treatment of focal articular cartilage lesions with autologous or allogeneic minced cartilage is considered experimental.

Inclusions

• For osteochondral allografting:
• This procedure is appropriate for patients with large (e.g., 10cm2), full-thickness chondral defect of the knee caused by acute or repetitive trauma in patients For osteochondral autografting
• This procedure is appropriate for patients with large (e.g., 10cm2), full-thickness chondral defect of the knee caused by acute or repetitive trauma in patients who have had an inadequate response to a prior surgical procedure. In addition, all of the following criteria must be met:
• Patient age:
• Adolescent patients should be skeletally mature with documented closure of growth plates (e.g., 15 years or older).
• Adult patients should be too young to be considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (e.g., younger than 55 years).
• Focal, full-thickness (grade III or IV) unipolar lesions on the weight-bearing surface of the femoral condyles or trochlea that are between 1 and 2.5 cm2 in size.
• Documented minimal to absent degenerative changes in the surrounding articular cartilage (Outerbridge grade II or less), and normal-appearing hyaline cartilage surrounding the border of the defect.
• Normal knee biomechanics, or alignment and stability achieved concurrently with osteochondral grafting.

Exclusions

• Osteochondral allografting or autografting for all other joints, including shoulder, elbow, and talar, and any indications other than those listed above is considered experimental/ investigational.
• Treatment of focal articular cartilage lesions with autologous or allogenic minced cartilage

81500

Basic benefit and medical policy
The safety and effectiveness of proteomics-based testing (eg. OVA1^® and ROMA™ tests) to identify women with adnexal masses who may benefit from referral to a gynecologic-oncology specialist have been established. These tests may be considered a useful (but not mandatory) diagnostic option in guiding referral to a gynecologic oncologist for women meeting defined criteria. This policy is effective Jan. 1, 2015.

Inclusions
The proteomics-based OVA1^® test and the ROMA™ (Risk of Ovarian Malignancy Algorithm [HE4 EIA + ARCHITECT CA 125 II]) tests are considered established when used as an aid to further assess the likelihood that malignancy is present when the physician’s (other than gynecologic oncologist) independent clinical and radiological preoperative evaluations do not indicate malignancy in a woman with an ovarian (adnexal) mass when all of the following criteria have been met:

• The woman should be older than age 18 years.
• Ovarian adnexal mass is present.
• Surgery is planned for treatment of the mass.
• The patient has not yet been referred to a gynecologic oncologist and referral to gynecologic oncologist is being considered in the event of a positive test result.

Exclusions
All other indications, including, but not limited to:

• Screening for ovarian cancer
• Selecting patients for surgery for an adnexal mass
• Evaluation of patients with clinical or radiologic evidence of malignancy

Group variations
Chrysler bargaining unit and non-bargaining unit, Ford hourly and URMBT are excluded from this change.

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Experimental:
0240T
0241T

Basic benefit and medical policy
The safety and effectiveness of conventional and high resolution manometry, esophageal pH testing and multichannel impedance testing have been established. They may be considered useful diagnostic options when indicated.

High-resolution esophageal pressure topography is considered experimental as its effectiveness beyond conventional manometry has not been established.  This policy is effective July 1, 2015.

Inclusions

• Esophageal testing (such as conventional and high resolution manometry, esophageal pH testing and multichannel impedance testing) using a catheter-based system may be considered established for the following clinical indications in adults and children or adolescents able to report symptoms:
• Documentation of abnormal acid exposure in endoscopy-negative patients being considered for surgical antireflux repair
• Evaluation of patients after antireflux surgery who are suspected of having ongoing abnormal reflux
• Evaluation of patients with either normal or equivocal endoscopic findings and reflux symptoms that are refractory to proton pump inhibitor therapy
• Evaluation of refractory reflux in patients with chest pain after cardiac evaluation and after a 1-month trial of proton pump inhibitor therapy
• Evaluation of suspected otolaryngologic manifestations of GERD (i.e., laryngitis, pharyngitis, chronic cough) that have failed to respond to at least 4 weeks of proton pump inhibitor therapy
• Evaluation of concomitant GERD in an adult-onset, nonallergic asthmatic suspected of having reflux-induced asthma
• Twenty-four hour catheter-based (such as esophageal pH testing, conventional manometry and multichannel impedance testing (pH as well as pressure) may be considered established in infants or children who are unable to report or describe symptoms of reflux with:
• Unexplained apnea
• Bradycardia
• Refractory coughing or wheezing, stridor, or recurrent choking (aspiration)
• Persistent or recurrent laryngitis
• Recurrent pneumonia
• Forty-eight hour to 96-hour, catheter-free, wireless esophageal monitoring (gastroesophageal reflux test) may be considered established for use in esophageal pH monitoring for patients who are unable to complete catheter-based testing and meet the criteria listed above.

Exclusions

• Three-dimensional high resolution esophageal pressure topography
• Forty-eight hour to 96-hour, catheter-free, wireless esophageal monitoring (gastroesophageal reflux test) wireless esophageal monitoring is considered experimental except as noted in the inclusionary guidelines above.

Basic benefit and medical policy
Optical coherence tomography of the breast and/or axillary lymph nodes is experimental/ investigational. The use of this technology in evaluating tumor margins has not been scientifically demonstrated to improve patient clinical outcomes. The policy effective date is July 1, 2015.

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Basic benefit and medical policy
The clinical utility of gene expression testing to predict coronary artery disease has not been demonstrated, and is therefore considered experimental/investigational.  This policy is effective July 1, 2015.

84999

Basic benefit and medical policy
Proteomic testing (including, but not limited to, the VeriStrat assay) to determine treatment for non small-cell lung cancer is experimental. There is insufficient evidence in medical literature to demonstrate that the use of this testing results in improved patient clinical outcomes. This policy is effective July 1, 2015.

Effective July 1, 2015, Medicare-eligible retirees of the City of Harper Woods will have Blue Cross Blue Shield of Michigan’s Medicare Advantage PPO plan, Medicare Plus Blue^SM Group PPO for their medical, surgical and prescription drug benefits. The group number is 67361 with suffixes 601 and 602. You can identify members by the XYL prefix on their ID cards, like those of other Medicare Plus Blue Group PPO plans.

For information about our Medicare Advantage PPO plan, go to bcbsm.com/provider/ma.

Miller, Canfield, Paddock, and Stone PLC

Miller, Canfield, Paddock and Stone PLC are joining Blue Cross Blue Shield of Michigan, effective July1, 2015.

Group number: 71710
Alpha prefix:  PPO (MFX)
Platform: NASCO

Plans offered:
PPO plan, Medical/surgical
Dental
Vision (VSP)

North Ottawa Community Health System

North Ottawa Community Health System is moving to the NASCO system, effective July 1, 2015.

Group number: 71712
Alpha prefix: JXP

Plans offered:

• Triple Tier High Plan with prescription drug benefits
• Triple Tier Low Plan with prescription drug benefits