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March 2019

Professional

Rollout of CAQH Direct Assure 2.0 continues in 2019

We are pleased to announce that the Phase I rollout of Direct Assure in 2018 was a success.

Background
CAQH Direct Assure allows you to see specific group affiliation information that is in our system so you can make updates and add group information to an individual provider’s CAQH record. Direct Assure also allows certain group changes made in CAQH to update the Blue Cross Blue Shield of Michigan system so you no longer have to make updates in both areas – the CAQH and Blue Cross systems. We decided to do a phased rollout to small subsets of providers. The first phase involved 4 percent of our practitioners in June 2018.

2018 initial results
The providers who participated in the first phase had higher-than-average accuracy scores for demographic data and better alignment of information between our data and CAQH data.

Plan for 2019
We rolled out Phase II in January 2019 to an additional 11 percent of our providers. We continue to work closely with provider group contacts on managing their data through Direct Assure.

The goal this year is to have all our providers using Direct Assure by the end of the year. We’ll continue to do a phased rollout at the end of each quarter until this is achieved.

If you have any questions, reach out to your provider consultant or contact Provider Enrollment at 1-800-822-2761.

Commercial home health service claims audit underway

In February, SCIO Health Analytics^®, an independent company working for Blue Cross Blue Shield of Michigan, began auditing claims for commercial home health services.

SCIO is conducting these audits to ensure that your billed and paid services over the past 18 months were ordered, medically necessary, documented, reported and covered under the patient’s contract, according to Blue Cross policies and guidelines.

If you’re a home health care provider, be ready to share medical charts for review.

After an audit, SCIO will share the findings and how to ask for an appeal, if necessary. The appeals process is simple:

For automated billing and compliance audits, disputed claims will be eligible for a one-step internal appeal.
For complex, medical necessity audits, an independent external review is the second step in the appeal process.

Have questions?
Contact your provider consultant. If you need to contact SCIO during an audit, call 1-866-628-3488, ext. 7526.

Remember to discuss fall risk, urinary incontinence and physical activity with Medicare patients

The Centers for Medicare & Medicaid Services is always looking for ways to improve health and its programs. One way CMS does this is through the Medicare Health Outcome Survey. Based on information supplied by the National Committee for Quality Assurance, a random sample of Medicare Advantage members will be surveyed to find out how providers talk to them about these HEDIS^® effectiveness of care measures:

Fall risk management
Management of urinary incontinence in older adults
Physical activity in older adults

The survey will be from April through July 2019.

The NCQA found that:

Falls are the leading cause of death by injury in people 65 and older; every year, 1 in 3 older adults falls.
Urinary incontinence is significantly underreported and underdiagnosed.
Any amount of physical activity reduces the risk of developing certain chronic conditions and increases quality of life.

Review the HOS tip sheet to learn more about the survey, including what questions are asked and how you can address care opportunities with patients.

For more information about the HOS, click here.**

HEDIS^® is a registered trademark of the National Committee for Quality Assurance, or NCQA.
**Blue Cross Blue Shield of Michigan doesn’t own or control this website.

Coding corner: Morbid obesity

Morbid obesity is a serious condition that typically builds slowly over time and leads to symptoms that interfere with basic physical functions, such as breathing, sleeping and walking. Long-term effects include shorter life expectancy and co-morbid conditions, such as Type 2 diabetes mellitus, heart disease, high blood pressure and obstructive sleep apnea.

The National Institutes of Health define morbid (severe) obesity in adults as:

BMI of 35 kg/m2 or one or more co-morbid conditions that can be linked to obesity
BMI of 40 kg/m2, regardless of conditions
More than 100 pounds over ideal body weight

Many providers are reluctant to document "morbid obesity" or "severe obesity" for fear of offending patients, but patients need an accurate understanding of their condition, and its detrimental effects on their overall health.

It’s appropriate to document "obesity" if the patient doesn’t meet any of the criteria listed above. On the other hand, if the patient meets one of the criteria for morbid (severe) obesity, it should be documented as such.

In addition, the provider should document any interventions or recommendations made during the visit to help the patient lose weight. This may include diet and exercise counseling, referral to a dietitian or a bariatric surgeon.

Coding tips

To assign code E66.01, the provider must specifically document either "morbid obesity" or "severe obesity" in the record and have a documented plan or intervention that addresses the patient’s morbid obesity.
When the provider documents "obesity" or "overweight," this leads to assignment of codes E66.9 or E66.3, respectively. This would be inappropriate in a patient who meets criteria for morbid obesity as it will reflect a lower than accurate severity of illness.
Documentation of the BMI value allows assignment of a separate set of codes (Z68.XX). Assignment of these codes at least once a year is an essential quality measure.
If the patient’s BMI is higher than normal (greater than 25), the provider must also document a clinical descriptor based on his or her interpretation of the BMI, such as "obese," "morbidly obese" or "overweight." This is especially important for patients with a BMI of 40 or greater as they meet the definition of morbid (severe) obesity.

Certain infusion drugs won’t be covered in outpatient hospitals, starting April 1

Beginning April 1, 2019, Blue Cross Blue Shield of Michigan is adding six pre-authorized medical drugs to the site of care requirement for members. Infusions for these drugs won’t be covered at hospital outpatient facilities without prior authorization for an approved location, starting April 1.

The authorization requirement only applies to groups that are currently participating in the commercial Medical Drug Prior Authorization Program for drugs administered under the medical benefit. These changes don’t apply to BCN Advantage^SM, Blue Cross Medicare Plus Blue^SM PPO or Federal Employee Program^® members.

Approved authorizations are payable for the following professional locations:

Physicians’ offices or other health care providers’ offices
Ambulatory infusion centers
The member’s home, from a home infusion therapy provider

If your patient currently receives one of these infusions at a hospital outpatient facility:

Submit a prior authorization request for your patient to Blue Cross for a hospital outpatient facility. If this request isn’t submitted and approved, the patient will be responsible for the full cost of the medicine.
Find out where your patient can continue his or her infusion therapy. Check the directory of participating home infusion therapy providers and infusion centers. Please confirm network participation for your patient before his or her infusion.
Tell your patient to contact any of the listed infusion therapy providers. If the infusion therapy provider can accommodate your patient, they’ll work with you and your patient to make the change easy. We’re also sending this information to your patient.
Help your patient switch his or her infusion therapy to your office, infusion center or home infusion therapy provider by April 1.

For the ordering provider:

If a member must receive one of these infusions in a hospital outpatient facility, please follow the normal steps for a prior authorization request and include:

The authorization number previously approved
Rationale that clearly describes the reason the infusion must be administered in a hospital setting
Supporting chart notes

The medical drugs subject to this requirement include:

Drug name	HCPCS
Crysvita^®	J0584
Fasenra^™	J0517
Ilumya^™	J3245
Mepsevii^™	J3397
Radicava^®	J1301
Trogarzo^™	J1746

For more information about hospital outpatient infusion therapy, view previous issues of The Record:

2017
October
December

2018
March
June
September

2019
January

Clarification: We’re removing providers on CMS preclusion list from our commercial and MA networks

In a January Record article, we notified health care providers that we’re required by the Centers for Medicare & Medicaid Services to remove providers from our Medicare Advantage networks if they are on the CMS preclusion list. We’re not allowed to pay member claims for medical and pharmacy Part D services for providers on the preclusion list, according to CMS.

We want to let you know that we’re also removing providers who are on the Medicare preclusion list from all Blue Cross Blue Shield of Michigan commercial and Blue Care Network HMO provider networks. These providers will be removed from our online provider directories. And providers on the preclusion list won’t be permitted to enroll in any of our commercial or Medicare Advantage networks.

For more information about the preclusion list, go to cms.gov** and type Preclusion list in the search box.

**Blue Cross Blue Shield of Michigan doesn’t own or control this website.

You can sign up to receive Blues Brief electronically

As announced in the January 2019 issue of The Record, Blues Brief has a new look and is now available by email subscription.

Why Blues Brief?
We know you’re very busy. Blues Brief offers a quick summary of several key articles that you can find in The Record and BCN Provider News.

Each month, provider consultants meet to select articles they want to make sure you don’t overlook. Summaries of these articles are then included in Blues Briefs with links to the full articles.

You may have received Blues Brief from your provider consultant in the past, but you can now subscribe to receive it in your in-box. You can choose from the monthly physician office version, quarterly hospital and facility version or both. You can also select specialty-specific versions that will be coming out this year for chiropractic and behavioral health providers, oncologists, and physical, occupational and speech therapy practices.

How to sign up
There are two ways to sign up:

Click the Manage Subscriptions link at the bottom of your email version of The Record or BCN Provider News. Once you make changes to your subscriptions, simply click on Update and we’ll process the changes. Our system doesn’t automatically acknowledge your changes, but we’ll be sure to add you to the distribution list.
Visit the subscription page to choose your preferred Blues Brief versions.

Keep in mind that Blues Brief is not intended to be a replacement for The Record. It’s important to review the entire publication each month to make sure you have all the information you need to do business with us.

Encourage patients to get these recommended cancer screenings

Cancer screening offers the best chance to find cancer as early as possible and achieve the best treatment outcome. Screening can identify abnormal changes on imaging studies or pre-cancerous cellular changes. And when detected early, cancer is, as you know, more easily treated.

The following provides an overview of American Cancer Society-recommended screenings for common cancers.

When is cervical cancer screening recommended?

All women should begin cervical cancer screening at age 21. Women aged 21 to 29 should have a Pap test every three years. HPV screening isn’t used in this age group unless it’s a follow-up to an abnormal Pap test.
Women aged 30 to 65 should be screened with a Pap test combined with an HPV test every five years, but a Pap test alone can be done every three years.

When is a mammogram recommended?

Women aged 40 to 44 should have the choice to start annual breast cancer screening with mammograms if they want to.
Women aged 45 to 54 should get mammograms every year.
Women 55 and older should switch to mammograms every two years or can continue yearly screening if desired.
Regular screening should continue if a woman is in good health and is expected to live 10 more years or longer.

Note: Based on the patient’s family history or other clinical risk factors, different age ranges may be indicated.

When is colon and rectal screening recommended?

Start regular screening for colorectal cancer at age 45 with either a sensitive test (fecal-based test) or with a colonoscopy (visual exam via colonoscope).
People aged 76 to 85 should talk with their health care provider to see if screening is right for them.
People older than 85 should no longer get colorectal screening. However, if non-colonoscopy test results are abnormal, a follow-up colonoscopy is indicated.

When is prostate screening recommended?

Men at average risk for prostate cancer should begin screening at age 50.
Men with more than one first-degree relative who had prostate cancer at an early age should start screenings at 40.
Men at high risk for prostate cancer should begin screenings at 45. High-risk men include:
- African-Americans
- Men who had a father, brother, son or other first-degree relative diagnosed with prostate cancer at an early age, which is younger than 65.

For more information on cancer screening, visit the American Cancer Society website.**

**Blue Cross Blue Shield of Michigan doesn't own or control this website.

All Providers

We invite you to join PGIP as an organized system of care

Blue Cross Blue Shield of Michigan encourages our participating network physicians and organized systems of care to get involved in the Physician Group Incentive Program.

PGIP has been improving the quality and efficiency of health care in Michigan for more than 12 years. That’s why we’re pleased to announce that we’ll accept applications from new OSCs from April 1 through April 30, 2019.

OSCs that apply before the April 30 deadline and are accepted into the program will be eligible to participate in PGIP’s new PPO risk program for OSCs, starting in 2020. We’ll provide more details about the program in future editions of The Record.

About organized systems of care: An OSC is a community of caregivers with a shared commitment to quality and cost-effective health care delivery for a defined population. These caregivers have committed to:

Deliver high-quality, cost-effective health care for a specific population.
Provide care and treatment to a patient population attributed to the community’s primary care physicians.
Join forces with one or more hospitals and other entities to share collective responsibility for a defined population of patients.

For more details about OSCs, visit the Models of Care section of our website.

If you represent an OSC and would like to join PGIP, send an email to valuepartnerships@bcbsm.com.

About physician organizations: A PGIP physician organization consists of physicians working together to:

Transform systems of care to effectively manage patient populations.
Build the infrastructure needed to optimize, measure and monitor quality of care.

Physician organizations promote collaborative relationships and support the most cost-effective delivery of services to improve patient outcomes.

Here’s the criteria for physicians joining PGIP:

Network primary and specialty care physicians

They can only join as part of a PGIP physician organization and must be affiliated with a PGIP physician organization to be a member of an organized system of care.
They should contact a PGIP-participating physician organization directly to discuss specific membership criteria.
- Here’s a current list of the more than 40 PGIP physician organizations. Each physician organization has its own criteria for membership. A physician can only be a member of one physician organization for the purposes of PGIP.

To participate in PGIP, a network physician must:

Participate in the Blue Cross PPO, TRUST or Traditional lines of business.
Be in good standing with the network.
Be a medical doctor, doctor of osteopathy, doctor of chiropractic, doctor of podiatric medicine, or fully licensed psychologist.

If you’re interested in participating in PGIP as an individual practitioner, send an email to valuepartnerships@bcbsm.com.

More information

About PGIP: PGIP is an innovative provider program developed with input from physicians across Michigan to help improve the quality and efficiency of health care in the state. PGIP facilitates change through approximately 20 initiatives, including our nationally recognized Patient-Centered Medical Home program. It offers incentives to participating physicians, physician organizations and organized systems of care for improving health care delivery. For more information, visit valuepartnerships.com.

Improve HEDIS scores through claims coding

What are CPT^® Category II and Z codes?

CPT Category II codes are performance measurement tracking codes. Z codes are health status diagnosis codes. Certain CPT II codes and Z codes facilitate data collection for HEDIS^® measures. Used together, they can give you credit for quality of care without the need for medical record review and can help close gaps for HEDIS measures.

CPT Category II codes describe clinical performance measures that are usually included in the evaluation and management process such as A1c or blood pressure values. They are entered in the procedure code field similar to CPT Category I codes.

Z codes are ICD-10 diagnosis codes that describe a patient’s health status. By submitting a claim with the appropriate Z code to indicate a patient’s body mass index, the need to submit the member’s medical record to validate BMI documentation may be eliminated.

Click here for a claims coding tip sheet with CPT II and ICD-10 codes for HEDIS measures.

HEDIS^® is a registered trademark of the National Committee for Quality Assurance.

Battling the opioid epidemic: A roundup of recent news and information

Opioid prescribing recommendations for surgery updated
The Michigan Opioid Prescribing Engagement Network, commonly referred to as M-OPEN, has updated its opioid prescribing recommendations** for specific surgical procedures. M-OPEN originally developed its recommendations based on patient-reported data from the Michigan Surgical Quality Collaborative and published studies. According to M-OPEN, studies have shown that when patients are prescribed fewer pills, they consume fewer pills with no changes in pain or satisfaction scores. Recommendations are for patients with no preoperative opioid use.

About 30 percent of opioid deaths may be suicides
An article published in The New England Journal of Medicine** last year estimated that as many as 30 percent of opioid overdoses may be suicides rather than unintentional deaths. According to the article, which analyzed Centers for Disease Control and Prevention data from 2000 to 2017, about 10 percent of suicides were from intentional overdose. And of those, a third involved opioids. In that period, deaths from suicide rose 60 percent, from 29,319 to 47,173, and the opioid-related suicide rate nearly doubled. In 2017, 1,887 Americans died of reported intentional opioid overdoses.

Opioid crisis may be here to stay, new analysis shows
An examination of nearly two decades of drug overdose deaths shows that shifts in the year-to-year death toll, marked by relatively predictable peaks and valleys, mask the true magnitude of the opioid epidemic in America, which now appears mired in a deadly new normal** for years to come, according to a U.S. News & World Report** analysis. The analysis states: "Trends that seem apparent in hindsight escaped notice for years, with the failure to recognize a climb in deaths at the turn of the millennium — along with a subsequent slowdown — raising a compelling question: Did policymakers, law enforcement and public health officials miss chances to curb the opioid epidemic before it became a full-blown emergency?"

Pain management task force outlines gaps in treatment of chronic pain
In December, the U.S. Department of Health and Human Services’ Pain Management Interagency Task Force released a draft report** outlining current gaps and preliminary recommendations for the treatment of acute and chronic pain. Following a 90-day comment period, the report will be finalized and submitted to Congress later this year. The task force was established by the Comprehensive Addiction and Recovery Act of 2016 and is tasked with determining whether gaps in or inconsistencies between best practices for acute and chronic pain management exist and to present updates and recommendations.

Data shows rural patients much more likely to receive an opioid prescription
A Morbidity and Mortality Weekly Report from the Centers for Disease and Control and Prevention in January 2019 addressed opioid use in rural, non-metropolitan counties. Researchers tracked opioid prescribing rates in counties across the country over a three-year period, from 2014 to 2017. The review found that over that time, general prescribing of prescription opioids fell while rates in rural, non-metropolitan counties declined at a slower rate. In the years following the implementation of the CDC’s chronic pain opioid prescribing guidelines,** the data demonstrated that rural patients were 87 percent more likely to receive an opioid prescription as compared to metropolitan patients.

**Blue Cross Blue Shield of Michigan doesn’t own or control this website.

HCPCS update: Code added

The Centers for Medicare & Medicaid Services has added a HCPCS code. The code, effective date and Blue Cross Blue Shield of Michigan’s coverage decision are below.

Outpatient Prospective Payment System
Medicine

Code	Change	Coverage comments	Effective date
C1890	Added	Not covered	Jan. 1, 2019

None of the information included in this article is intended to be legal advice and, as such, it remains the provider’s responsibility to ensure that all coding and documentation are done in accordance with all applicable state and federal laws and regulations.

Billing chart: Blues highlight medical, benefit policy changes

You’ll find the latest information about procedure codes and Blue Cross Blue Shield of Michigan billing guidelines in the following chart.

This billing chart is organized numerically by procedure code. Newly approved procedures will appear under the New Payable Procedures heading. Procedures for which we have changed a billing guideline or added a new payable group will appear under Updates to Payable Procedures. Procedures for which we are clarifying our guidelines will appear under Policy Clarifications. New procedures that are not covered will appear under Experimental Procedures.

You will also see that descriptions for the codes are no longer included. This is a result of recent negotiations with the AMA on use of the codes.

We will publish information about new BCBS groups or changes to group benefits under the Group Benefit Changes heading.

For more detailed descriptions of the BCBSM policies for these procedures, please check under the Medical/Payment Policy tab in Explainer on web-DENIS. To access this online information:

Log in to web-DENIS.
Click on BCBSM Provider Publications & Resources.
Click on Benefit Policy for a Code.
Click on Topic.
Under Topic Criteria, click on the drop-down arrow next to Choose Identifier Type and then click on HCPCS Code.
Enter the procedure code.
Click on Finish.
Click on Search.

Code*

BCBSM changes to:
Basic Benefit and Medical Policy, Group
Variations Payment Policy, Guidelines

NEW PAYABLE PROCEDURES

0017U, 81219, 81270, 81402, 81403

Basic benefit and medical policy

Genetic testing: JAK2, MPL and CALR testing for myeloproliferative neoplasms

The safety and effectiveness of JAK2 testing has been established. It may be considered a useful diagnostic option for patients presenting with clinical, laboratory or pathologic findings suggesting polycythemia vera, essential thrombocythemia or primary myelofibrosis.

The safety and effectiveness of MPL and CALR testing have been established. They may be considered useful diagnostic options for patients presenting with clinical, laboratory or pathologic findings suggesting essential thrombocythemia or primary myelofibrosis.

The peer-reviewed medical literature hasn’t yet demonstrated the clinical utility for JAK2, MPL and CALR testing in other circumstances. Therefore, these services are considered experimental in all other situations, including, but not limited to, the following:

Diagnosis of nonclassic forms of myeloproliferative neoplasms, known as MPNs
Molecular phenotyping of patients with MPNs
Monitoring, management or selecting treatment in patients with MPNs

Procedure code 0017U has been added as a covered service for members meeting selection criteria, effective Nov. 1, 2018.

Payment policy

It isn’t payable in an office or ambulatory surgical facility. Modifiers 26 and TC don’t apply.

Inclusionary guidelines:

JAK2 testing as a diagnostic option for patients presenting with clinical, laboratory or pathologic findings suggesting polycythemia vera, essential thrombocythemia or primary myelofibrosis.

Based on World Health Organization criteria, in the case of suspected polycythemia vera, documentation of serum erythropoietin level below the reference range for normal is recommended prior to JAK2 testing.

MPL and CALR testing as diagnostic options for patients presenting with clinical, laboratory or pathologic findings suggesting essential thrombocythemia or primary myelofibrosis.

Exclusionary guidelines:

JAK2, MPL and CALR testing in other circumstances including, but not limited to, the following:

Diagnosis of nonclassic forms of myeloproliferative neoplasms
Molecular phenotyping of patients with MPNs
Monitoring, management or selecting treatment in patients with MPNs

55873, 55899, C9747**

**Covered for Medicare only. Otherwise, use unlisted procedure.

Basic benefit and medical policy

Focal treatments for prostate cancer

Cryoablation of the prostate is considered established as treatment of clinically localized (organ-confined) prostate cancer when performed as one of the following:

An initial treatment
A salvage treatment of disease that recurs following radiotherapy, when criteria are met.

High-intensity focused ultrasound of the prostate is considered established:

As salvage treatment of disease that recurs following radiotherapy, when criteria are met

Focal laser ablation, radiofrequency ablation and photodynamic therapy for the treatment of localized prostate cancer are considered experimental as they haven’t been shown to improve patient clinical outcomes.

The update to this policy is effective March 1, 2019.

Inclusions:

Cryosurgery may be considered established for the initial treatment of clinically localized (organ-confined) prostate cancer.

Cyrosurgery or high-intensity focused ultrasound may be considered established for local treatment of recurrent prostate cancer when all the following criteria are met:

Primary treatment of prostate cancer was radiation therapy and all the following:
- Original clinical stage T1-T2, NX or N0
- Life expectancy >10 y
- PSA now <10 ng/mL
Transrectal ultrasound guided biopsy is positive.
Studies are negative for distant metastases.

Exclusions:

Local treatment of recurrent prostate cancer that doesn’t meet criteria.

Focal laser ablation, radiofrequency ablation and photodynamic therapy for the treatment of localized prostate cancer are considered experimental.

J9299

Basic benefit and medical policy

Opdivo (nivolumab)

Effective Aug. 10, 2017, the FDA-approved indications for Opdivo (nivolumab), identified by procedure code J9299, NDC 00003 3774-12 and NDC 0000 3772-11, are being maintained.

Revenue code 1006

Basic benefit and medical policy

1006 will reject as ‘not a covered benefit’

The National Uniform Billing Committee approved new revenue code 1006, effective July 1, 2017. Revenue code 1006 will reject as "not a covered benefit."

UPDATES TO PAYABLE PROCEDURES

77046, 77047

Basic benefit and medical policy

MRI for detection and diagnosis of breast cancer

The safety and effectiveness of magnetic resonance imaging of the breast have been established. It may be considered a useful diagnostic option for patients meeting criteria. The inclusionary criteria have been updated, effective March 1, 2019.

Payment policy

Subject to the PPO Radiology Management Program

Inclusions:

Note: All the following policy statements refer to performing MRI of the breast with a breast coil and the use of contrast. MRI of the breast without the use of a breast coil, regardless of the clinical indication, is considered experimental.

MRI of the breast may be considered medically appropriate for screening for breast cancer in patients at a high risk of breast cancer.

High-risk considerations

There is no standardized method for determining a woman’s risk of breast cancer that incorporates all possible risk factors. There are validated risk prediction models, but they are based primarily on family history.

Some known individual risk factors confer a high risk by themselves. The following list includes factors known to indicate a high risk of breast cancer:

Lobular carcinoma in situ, atypical lobular hyperplasia/atypical ductal hyperplasia
A known BRCA1 or BRCA2 variant
Another gene variant associated with high risk, e.g., TP53 (Li-Fraumeni syndrome), PTEN (Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome), CDH1, STK11, ATM, CHEK2, PALB2, NBN, NF1
High risk (lifetime risk about 20 percent or greater) of developing breast cancer as identified by models that are largely defined by family history
Received radiotherapy to the chest between ages 10 to 30

A number of factors may increase the risk of breast cancer but don’t by themselves indicate high risk. It’s possible that combinations of these factors may be indicative of high risk, but it isn’t possible to give quantitative estimates of risk. As a result, it may be necessary to individualize the estimate of risk, whereby one would need to take into account the numerous risk factors. A number of risk factors, not individually indicating high risk, are included in the National Cancer Institute Breast Cancer Risk Assessment Tool (also called the Gail model). Risk factors in the model can be accessed online at https://bcrisktool.cancer.gov/.

National Cancer Care Network guidelines state there is insufficient evidence for any recommendations for breast MRI for patients with the following variants: BARD1, BRIP1, FANCC, MRE11A, MUTYH, RAD50, RINT1, SLX4, SMARCA, or XRCC2. Moreover, there are conflicting data regarding risks associated with RAD51C, RAD51D, MLH1, MSH2, MSH6, PMS2 and EPCAM gene deletion.

MRI of the breast is medically appropriate for the following indications:
- Detection of a suspected occult breast primary tumor in patients with axillary nodal adenocarcinoma (i.e., negative mammography and physical exam)
- Presurgical planning in patients with locally advanced breast cancer (before and after completion of neoadjuvant chemotherapy) to permit tumor localization and characterization
- Determining the presence of pectoralis major muscle/chest wall invasion in patients with posteriorly located tumor
- Evaluation of the contralateral breast in those patients with a new diagnosis of breast cancer when clinical and mammographic findings are normal
- Preoperative tumor mapping of the involved (ipsilateral) breast to evaluate the presence of multicentric disease in patients with clinically localized breast cancer who are candidates for breast-conservation therapy.
- Evaluation of a documented abnormality of the breast before obtaining an MRI-guided biopsy when there is documentation that other methods, such as palpation or ultrasound, aren’t able to localize the lesion for biopsy.

Exclusions:

Screening technique in average-risk patients
Screening technique for the detection of breast cancer when the sensitivity of mammography is limited (i.e., dense breasts)
Diagnosis of low-suspicion findings on conventional testing not indicated for immediate biopsy and referred for short-interval follow-up
Diagnosis of a suspicious breast lesion to avoid biopsy

96446

Basic benefit and medical policy

Hyperthermic intraperitoneal chemotherapy for select intra-abdominal and pelvic malignancies

The safety and effectiveness of hyperthermic intraperitoneal chemotherapy when used in combination with cytoreductive surgery have been established. It may be considered a useful therapeutic option for patients meeting patient selection criteria.

Inclusionary criteria has been revised, effective March 1, 2019.

Inclusions:

The patient must meet one of the following criteria:

A diagnosis of pseudomyxoma peritonei
A diagnosis of diffuse malignant peritoneal mesotheliomas or ovarian cancer confirmed by the treating physician
A newly diagnosed epithelial ovarian or fallopian tube cancer at the time of interval cytoreductive surgery
The patient must be able to tolerate the extensive cytoreductive surgery and hyperthermic intraperitoneal chemotherapy.
Peritoneal disease must be potentially completely resectable or significantly reduced.
There must be no metastases to other organs or to the retroperitoneal space.

Exclusions:

A diagnosis of peritoneal carcinomatosis from colorectal cancer, gastric cancer or endometrial cancer
Goblet cell tumors of the appendix
All other indications

POLICY CLARIFICATIONS

A4351
A4352
A4353

Basic benefit and medical policy

A4351 and A4352 aren’t separately reimbursable when billed with A4353

Procedures codes A4351 and A4352 aren’t separately reimbursable when billed with A4353.

When procedure codes A4351 and A4352 are billed together with A4353, procedure codes A4351 and A4352 will reject. When procedure codes A4351 and A4352 are billed without A4353, then current processing of these codes will execute.

A9699
C9399

Basic benefit and medical policy

Azedra (iobenguane I 131)

Effective July 30, 2018, Azedra (iobenguane I 131) is covered for the following FDA-approved indications:

Azedra (iobenguane I 131) is a radioactive therapeutic agent indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.

Verify pregnancy status in females of reproductive potential before administering Azedra (iobenguane I 131). Block thyroid before administering Azedra (iobenguane I 131). Don’t administer if platelet count is less than 80,000/mcL or absolute neutrophil count is less than 1,200/mcL.

J0717

Basic benefit and medical policy

Cimzia (certolizumab pegol)

Effective May 25, 2018, Cimzia (certolizumab pegol) is payable for the following newly approved FDA indication: Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. This is in addition to the existing payable indications for:

Reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
Treatment of adults with moderately to severely active rheumatoid arthritis.
Treatment of adult patients with active psoriatic arthritis.
Treatment of adults with active ankylosing spondylitis.

Cimzia (certolizumab pegol) is a tumor necrosis factor blocker.

Cimzia (certolizumab pegol) is administered by subcutaneous injection. The initial dose of Cimzia (certolizumab pegol) is 400 mg given as two subcutaneous injections of 200 mg.

J9035

Basic benefit and medical policy

Avastin (bevacizumab)

Avastin (bevacizumab) is payable for the following new FDA indications:

Epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with:
- Carboplatin and paclitaxel, followed by Avastin as a single agent, for Stage III or IV disease following initial surgical resection
- Paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than two prior chemotherapy regimens
- Carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Avastin as a single agent, for platinum-sensitive recurrent disease

This is in addition to the following existing FDA-approved indications:

Metastatic colorectal cancer, in combination with intravenous five-fluorouracil-based chemotherapy for first- or second-line treatment.
Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line Avastin-containing regimen.

Limitation of use: Avastin (bevacizumab) isn’t indicated for adjuvant treatment of colon cancer.

Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment
Recurrent glioblastoma in adults
Metastatic renal cell carcinoma in combination with interferon alfa
Persistent, recurrent or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.

Dosage information:

Don’t administer Avastin (bevacizumab) for 28 days following major surgery and until surgical wound is fully healed.

Metastatic colorectal cancer:
- 5 mg/kg every two weeks with bolus-IFL
- 10 mg/kg every two weeks with FOLFOX4
- 5 mg/ kg every two weeks or 7.5 mg/kg every three weeks with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy after progression on a first-line Avastin containing regimen
First-line non-squamous non-small cell lung cancer:
- 15 mg/kg every three weeks with carboplatin and paclitaxel Recurrent glioblastoma
Recurrent glioblastoma:
- 10 mg/kg every two weeks
Metastatic renal cell cancer:
- 10 mg/kg every two weeks with interferon alfa
Persistent, recurrent or metastatic cervical cancer:
- 15 mg/kg every three weeks with paclitaxel and cisplatin, or paclitaxel and topotecan
Stage III or IV epithelial ovarian, fallopian tube or primary peritoneal cancer following initial surgical resection:
- 15 mg/kg every three weeks with carboplatin and paclitaxel for up to six cycles, followed by 15 mg/kg every three weeks as a single agent, for a total of up to 22 cycles
Platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer:
- 10 mg/kg every two weeks with paclitaxel, pegylated liposomal doxorubicin or topotecan given every week
- 15 mg/kg every three weeks with topotecan given every three weeks
Platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer:
- 15 mg/kg every three weeks with carboplatin and paclitaxel for six to eight cycles, followed by 15 mg/kg every three weeks as a single agent
- 15 mg/kg every three weeks with carboplatin and gemcitabine for six to 10 cycles, followed by 15 mg/kg every three weeks as a single agent

Administer as an intravenous infusion.

Pharmacy doesn’t require preauthorization of this drug.

NDCs: 50242 0060 01 and 50242 0061 01

69710, 69711, 69714, 69715, 69717, 69718, L8625, L8690, L8691, L8693, L8694

Basic benefit and medical policy

Implantable bone-conduction and bone-anchored hearing devices

The safety and effectiveness of unilateral or bilateral fully or partially implanted bone-conduction (bone-anchored) hearing aids have been established. They may be considered a useful therapeutic option when indicated.

Inclusionary criteria have been updated, effective March 1, 2019.

Inclusions:

Conductive hearing loss
Unilateral or bilateral fully or partially implantable bone-conduction** (bone-anchored) hearing aids may be necessary as an alternative to an air-conduction hearing aid in patients age 5 and older with conductive or mixed hearing loss who also meet at least one of the following criteria:

Congenital or surgically induced malformations (e.g., atresia) of the external ear canal or middle ear
Chronic external otitis or otitis media
Tumors of the external canal and/or tympanic cavity
Chronic dermatitis of the external canal prohibiting the usage of an air-conduction hearing aid

And meet the following audiologic criteria:

A pure-tone average bone-conduction threshold measured at 0.5, 1, 2 and 3 kHz or better than or equal to 45 dB (OBC and BP100, Baha 4 and Baha 5 devices), 55 dB (Intenso device) or 65 dB (Cordele II and Baha 5 SuperPower devices).

For bilateral implantation, patients should meet the above audiologic criteria in both ears and have symmetrically conductive or mixed hearing loss as defined by a difference between left and right side bone-conduction threshold of less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz (4 kHz for OBC and Ponto Pro), or less than 15 dB at individual frequencies.

Sensorineural hearing loss**

A unilateral implantable bone-conduction (bone-anchored) hearing aid may be considered medically necessary as an alternative to an air-conduction contralateral routing of signal hearing aid in patients age 5 and older with single-sided sensorineural deafness and normal hearing in the other ear. The pure-tone average air-conduction threshold of the normal ear should be better than 20 dB measured at 0.5, 1, 2 and 3 kHz.

**The Audiant^® bone conductor is a bone-conduction hearing device. While this product is no longer actively marketed, patients with existing Audiant devices may require replacement, removal or repair.

In patients being considered for implantable bone-conduction (bone-anchored) hearing aids, skull bone quality and thickness should be assessed for adequacy to ensure implant stability. Additionally, patients (or caregivers) must be able to perform proper hygiene to prevent infection and ensure the stability of the implants and percutaneous abutments.

Exclusions:

Other uses of implantable bone-conduction (bone-anchored) hearing aids, including use in patients with bilateral sensorineural hearing loss, are considered experimental.

Established: 81162, 81163, 81164, 81165, 81166 81167, 81212, 81215, 81216, 81217

Investigational, not medically necessary: 81432, 81433, 81479

Basic benefit and medical policy

Genetic testing for BRCA1 or BRCA2 for hereditary breast/ovarian cancer syndrome and other high-risk cancers

The safety and effectiveness of simultaneous testing for inherited BRCA1 and BRCA2 variants have been established. It may be considered a useful diagnostic option when indicated for individuals at high risk of breast or ovarian cancer.

Testing for genomic rearrangements of the BRCA1 and BRCA2 genes (e.g., BART testing) may be considered established in patients who meet criteria for BRCA1 and BRCA2 testing and whose testing for point variants is negative.

Use of multi-gene panels, including but not limited to BreastNext, OvaNext, BRCAplus, iGene Cancer Panel and BROCA tests, is experimental. There is insufficient data on the analytical and clinical validity as well as clinical utility of these tests on patient management and outcomes.

Inclusionary and exclusionary guidelines

It’s highly recommended that genetic testing should be performed in a setting that has suitably trained health care providers who can give appropriate pre- and post-test counseling and that has access to a Clinical Laboratory Improvement Amendments, known as CLIA, licensed laboratory that offers comprehensive variant analysis.

Notes:

For the purpose of familial assessment, first-, second- and third-degree relatives are blood relatives on the same side of the family (maternal or paternal), such as:
- First-degree relatives, which are parents, siblings and children
- Second-degree relatives, which are grandparents, aunts, uncles, nieces, nephews, grandchildren and half-siblings
- Third-degree relatives, which are great-grandparents, great-aunts, great-uncles, great-grandchildren and first cousins
For the purpose of familial assessment, aggressive prostate cancer is defined as Gleason score ≥7.
Testing for Ashkenazi Jewish or another founder variants, if applicable, should be performed first.

Inclusions:

Patients with cancer or with a personal history of cancer (affected patients):

Genetic testing for BRCA1 and BRCA2 variants in cancer-affected individuals may be considered appropriate under any of the following circumstances:

Individuals from a family with a known BRCA1/BRCA2 variant
Personal history of breast cancer and one or more of the following:
- Diagnosed at age 45 or younger and has the variant
- Diagnosed at ages 46 to 50 years with:
  - An additional breast cancer primary at any age
  - At least one close relative with breast cancer at any age
  - At least one close relative with high grade (Gleason score ≥7) prostate cancer
  - An unknown or limited family history
- Diagnosed at age 60 or younger with:
  - Triple-negative breast cancer
- Diagnosed at any age with:
  - At least one close blood relative with one of the following:
    1. Breast cancer diagnosed at age 50 or younger
    2. Ovarian carcinoma
    3. Male breast cancer
    4. Metastatic prostate cancer
    5. Pancreatic cancer
  - At least two additional diagnoses of breast cancer at any age in patient or close blood relative
- Ashkenazi Jewish ancestry
Personal history of ovarian carcinoma
Personal history of male breast cancer
Personal history of pancreatic cancer
Personal history of high-grade prostate cancer (Gleason score ≥7) at any age with:
- At least one close blood relative with ovarian carcinoma, pancreatic cancer or metastatic prostate cancer at any age or breast cancer at younger than age 50
- At least two close blood relatives with breast or prostate cancer (any grade) at any age
- Ashenazi Jewish ancestry
BRCA1 or BRCA2 pathogenic or likely pathogenic variant detected by tumor profiling on any tumor type in the absence of germline pathogenic or likely pathogenic variant analysis
Regardless of family history, some individuals with an BRCA-related cancer may benefit from genetic testing to determine eligibility for targeted treatment.
An individual who doesn’t meet the other criteria but with at least one first- or second-degree blood relatives meeting any of the above criteria

Note: If there is a family history of ovarian cancer, it may not be possible to determine if the pathology was epithelial ovarian cancer, germ cell or some other type. Since up to 90 percent of ovarian cancers are epithelial in origin, determining the exact cell type isn’t necessary.

Testing for genomic rearrangements of the BRCA1 and BRCA2 genes for patients who meet criteria for BRCA testing and whose testing for point variants is negative.

Patients without cancer or without a history of cancer (unaffected patients):

Testing of unaffected individuals should ideally only be considered when an appropriate affected family member is unavailable for testing. Testing is appropriate in the following circumstances:

Individual from a family with a known BRCA1/BRCA2 variant
A first- or second-degree blood relative meeting any criterion listed above for "patients with cancer"
Third-degree blood relative with breast cancer or ovarian/fallopian tube/primary peritoneal cancer and at least two first-, second- or third-degree relatives with breast cancer (at least one at age 50 years or younger) or ovarian/fallopian tube/primary peritoneal cancer

81201-81203, 81210, 81288, 81292- 81301, 81317-81319, 81401, 81403, 81406, 81435, 81436

Not covered:
81327, 81528

Basic benefit and medical policy

Genetic testing for Lynch and other inherited colon cancer syndromes

The safety and effectiveness of genetic testing for polyposis and non-polyposis cancer syndromes have been established. They may be considered useful diagnostic options for individuals who meet clinical criteria for increased risk of hereditary colorectal cancer.

Inclusionary criteria have been updated, effective March 1, 2019.

Inclusions:

These guidelines refer to the different types of genetic tests available for colorectal cancer.

Genetic testing of the adenosis polyposis coli, or APC, gene is established in any of the following:
- At-risk relatives** (i.e., siblings, parents and offspring) of patients with FAP or AFAP or a known APC variant.
- Patients with a differential diagnosis of attenuated FAP versus MUTYH-associated polyposis, or MAP, versus Lynch syndrome. Whether testing begins with APC variants or screening for mismatch repair MMR variants depends on clinical presentation.

**Due to the high lifetime risk of cancer of the majority of the genetic syndromes discussed in this policy, "at-risk relatives" primarily refers to first-degree relatives. However, some judgment must be allowed, for example, in the case of a small family pedigree, when extended family members may need to be included in the testing strategy.

It’s recommended that, when possible, initial genetic testing for familial adenomatous polyposis, known as FAP, or Lynch syndrome be performed in an affected family member so that testing in unaffected family members can focus on the variant found in the affected family member.

Genetic testing for MUTYH gene variants is established in all the following:
- Patients with a differential diagnosis of attenuated familial adenomatous polyposis (FAP) vs. MUTYH-associated polyposis (MAP) vs. Lynch syndrome
- Negative result for APC gene variants
- Negative family history of no parents or children with FAP is consistent with autosomal recessive MAP

In many cases, genetic testing for MUTYH gene variants should first target the specific variants Y165C and G382D, which account for more than 80 percent of variants in white populations and subsequently proceed to sequencing only as necessary. In other ethnic populations, however, proceeding directly to sequencing is appropriate.

Genetic testing for MMR gene variants (MLH1, MSH2, MSH56, PMS2) to determine the carrier status of Lynch syndrome is established in any of the following:
- Patients with colorectal cancer to test for the diagnosis of Lynch syndrome
- Patients with endometrial cancer and a first-degree relative diagnosed with a Lynch-associated cancer, for the diagnosis of Lynch syndrome
- At-risk relatives of patients with Lynch syndrome with a known MMR variant
- Patients with a differential diagnosis of attenuated FAP versus MAP versus Lynch syndrome. Whether testing begins with APC variants or screening for MMR genes depends on clinical presentation.
- Patients without colorectal cancer but with a family history meeting the Amsterdam or revised Bethesda criteria when:
  - No affected family members have been tested for MMR variants.

For patients with colorectal cancer being evaluated for Lynch syndrome, either the microsatellite instability, known as MSI, test or the immunohistochemical, known as IHC, test with or without BRAF gene variant testing, should be used as an initial evaluation of tumor tissue before mismatch repair MMR gene analysis. Both tests are not necessary. Proceeding to MMR gene sequencing would depend on results of MSI or IHC testing. In particular, IHC testing may help direct which MMR gene likely contains a variant, if any, and may also provide additional information if MMR genetic testing is inconclusive.

When indicated, genetic sequencing for MMR gene variants should begin with MLH1 and MSH2 genes, unless otherwise directed by the results of IHC testing. Standard sequencing methods won’t detect large deletions or duplications; when MMR gene variants are expected based on IHC or MSI studies but none are found by standard sequencing, additional testing for large deletions or duplications is appropriate.

Genetic testing for EPCAM gene variants is established when any of the following major criteria (solid bullets) is met:
- Patients with colorectal cancer, for the diagnosis of Lynch syndrome when (one of the following):
  - Tumor tissue shows lack of MSH2 protein expression by immunohistochemistry and patient is negative for a MSH2 germline variant.
  - Tumor tissue shows a high level of microsatellite instability and patient is negative for a germline variant in MSH2, MLH1, PMS2 and MSH6.
- At-risk relatives of patients with Lynch syndrome with a known EPCAM variant
- Patients without colorectal cancer but with a family history meeting the Amsterdam or revised Bethesda criteria when (each of the following):
  - No affected family members have been tested for MMR variants.
  - Sequencing for MMR variants is negative.

The Amsterdam II clinical criteria (all criteria must be fulfilled) are the most stringent criteria for defining families at a high risk for Lynch syndrome (Vasen et al., 1999):

Three or more relatives with an associated cancer (colorectal cancer or cancer of the endometrium, small intestine, ureter or renal pelvis)
One should be a first-degree relative of the other two.
Two or more successive generations affected
One or more relatives diagnosed before age 50
Familial adenomatous polyposis should be excluded in cases of colorectal carcinoma.
Tumors should be verified by pathologic examination.
Modifications, one of the following:
- Very small families, which can’t be further expanded, can be considered to have hereditary nonpolyposis colorectal cancer with only two colorectal cancers in first-degree relatives if at least two generations have the cancer and at least one case of colorectal cancer was diagnosed by the age of 55.
- In families with two first-degree relatives affected by colorectal cancer, the presence of a third relative with an unusual early-onset neoplasm or endometrial cancer is sufficient.

The revised Bethesda guidelines (fulfillment of any criterion meets guidelines) are less strict than the Amsterdam criteria and are intended to increase the sensitivity of identifying at-risk families (Umar et al., 2004). The Bethesda guidelines are also considered more useful in identifying which patients with colorectal cancer should have their tumors tested for microsatellite instability and/or immunohistochemistry:

Colorectal carcinoma, or CRC, diagnosed in a patient who is younger than age 50.
Presence of synchronous or metachronous CRC or other HNPCC-associated tumors,** regardless of age.
CRC with high microsatellite instability histology diagnosed in a patient younger than age 60.
CRC diagnosed in one or more first-degree relatives with a Lynch syndrome-associated tumor, with one of the cancers being diagnosed at younger than age 50.
CRC diagnosed in two or more first- or second-degree relatives with HNPCC-related tumors,** regardless of age.

**HNPCC-related tumors include colorectal, endometrial, stomach, ovarian, pancreas, ureter and renal pelvis, biliary tract, brain (usually glioblastoma as seen in Turcot syndrome), sebaceous bland adenomas and keratoacanthomas in Muir-Torre syndrome, and carcinoma of the small bowel.

Genetic testing for BRAF V600E or MLH1 promoter methylation is established to exclude a diagnosis of Lynch syndrome when:
- MLH1 protein is not expressed in a colorectal cancer tumor on immunohistochemical analysis.
Genetic testing for SMAD4 and BMPR1A gene variants is established when any of the following major criteria (solid bullets) is met:
- Individual has a clinical diagnosis of juvenile polyposis syndrome based on the presence of any one of the following:
  - At least three to five juvenile polyps in the colon.
  - Multiple juvenile polyps in other parts of the gastrointestinal tract.
  - Any number of juvenile polyps in a person with a known family history of juvenile polyps.
- Individual is an at-risk relative of a patient suspected of or diagnosed with juvenile polyposis syndrome.
Genetic testing for STK11 gene variants is established when any of the following major criteria (solid bullets) is met:
- Individual has a clinical diagnosis of Peutz-Jeghers syndrome based on the presence of any two of the following secondary criteria:
  - Presence of two or more histologically confirmed Peutz-Jeghers polyps of the small intestine.
  - Characteristic mucocutaneous pigmentation of the mouth, lips, nose, eyes, genitalia or fingers.
  - Family history of Peutz-Jeghers syndrome.
- Individual is an at-risk relative of a patient suspected of or diagnosed with Peutz-Jeghers syndrome.

Pre- and post-test genetic counseling is established as an adjunct to genetic testing.

Note: Genetic counseling is primarily aimed at patients who are at risk for inherited disorders, and experts recommend formal genetic counseling in most cases when genetic testing for an inherited condition is considered. The interpretation of the results of genetic tests and the understanding of risk factors can be very difficult and complex. Therefore, genetic counseling will assist individuals in understanding the possible benefits and harms of genetic testing, including the possible effect of the information on the individual’s family. Genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Exclusions:

Genetic testing for APC gene variants is considered investigational for colorectal cancer patients with classical FAP for confirmation of the FAP diagnosis.

Genetic testing for all other gene variants for Lynch syndrome or colorectal cancer is considered experimental.

81595

Investigational:
0085T, 0055U, 81479

Basic benefit and medical policy

Laboratory tests for heart and kidney transplant rejection

The safety and effectiveness of gene expression profiling (AlloMap) have been established for the detection of heart transplant rejection. It may be considered a useful therapeutic option when specified criteria have been met.

The breath test (e.g., Heartsbreath^™) for the evaluation of heart transplant rejection is considered experimental. The effectiveness and clinical utility of this test haven’t been clearly established.

The use of peripheral blood measurement of donor-derived cell-free DNA in the management of patients after renal transplantation, including but not limited to the detection of acute renal transplant rejection or renal transplant graft dysfunction, is experimental. The effectiveness and clinical utility of this test haven’t been clearly established.

The exclusions have been updated, effective March 1, 2019.

Inclusions:

Gene expression profiling (AlloMap) may be appropriate as a screening technique for heart transplant rejection in recipients who are:

At least 15 years old, and
Six months post-heart transplant

And recipients must have stable heart allograft function demonstrated by all of the following:

Left ventricular ejection fraction ≥45 percent that has been confirmed by echocardiogram
No evidence of CHF
No evidence of severe cardiac allograft vasculopathy

And recipients must have a low probability of moderate or severe acute cellular rejection as demonstrated by the following:

Clinical assessment (e.g., International Society for Heart and Lung Transplantation rejection status Grade of 0R or 1R)
No history or evidence of antibody mediated rejection

Exclusions:

Gene expression profiling (i.e., AlloMap) for any other indication
Breath testing (e.g., Heartsbreath^™)
Peripheral blood measurement of donor-derived cell-free DNA to detect acute renal transplant rejection or renal transplant graft dysfunction
myTAIHEART testing

Established: 95249, 95250, 95251, A9276, A9277, A9278, A9279, K0553, K0554

Investigational: 99091, S1030, S1031

Basic benefit and medical policy

Intermittent (72 hours or more) or continuous invasive glucose monitoring

The safety and effectiveness of FDA-approved continuous glucose monitoring systems, on an intermittent (72 hours or more) or continuous basis, have been established. Both may be considered useful therapeutic devices for patients meeting the relevant patient selection criteria. The inclusionary criteria have been updated.

This policy is effective March 1, 2019.

Inclusions:

Seventy-two hour monitoring of glucose levels in interstitial fluid to optimize patient management may be considered established in the following situations when any of the following criteria are met:

Patients with Type 1 diabetes who despite current use of best practices have poorly controlled diabetes, including hemoglobin A1c not in acceptable target range for the patient’s clinical situation, unexplained hypoglycemic episodes, evidence suggesting postprandial hyperglycemia or recurrent diabetic ketoacidosis
Patients with Type 1 diabetes before insulin pump initiation to determine basal insulin levels
Women with Type 1 diabetes who are pregnant or about to become pregnant and have poorly controlled diabetes

Continual (i.e., long-term) monitoring of glucose levels in interstitial fluid, including real-time monitoring, as a technique in diabetic monitoring may be considered established in any of the following situations:

Patients with Type 1 diabetes who have demonstrated an understanding of the technology, are motivated to use the device correctly and consistently, are expected to adhere to a comprehensive diabetes treatment plan supervised by a qualified provider and are capable of using the device to recognize alerts and alarms
Patients with Type 1 diabetes who have recurrent, unexplained, severe (generally blood glucose levels <50 mg/dL) hypoglycemia or impaired awareness of hypoglycemia that puts the patient or others at risk
Patients with poorly controlled Type 1 diabetes who are pregnant. Poorly controlled Type 1 diabetes includes unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia and recurrent diabetic detoacidosis.

Intermittent monitoring of glucose levels in interstitial fluid may also be considered established in patients with Type 1 diabetes before insulin pump initiation to determine basal insulin levels.

Exclusions:

Other uses of continuous monitoring of glucose levels in interstitial fluid (including real-time monitoring) as a technique of diabetic monitoring are considered experimental, including:

Patients not meeting the inclusionary criteria above.
For convenience purposes, such as (but not limited to) lifestyle or employment circumstances.

Replacement:

Replacement of a CGMS may be considered when:

The transmitter is out of warranty.
The transmitter is malfunctioning.
There is documented evidence the member is compliant with their current CGMS device. Compliance is defined as at least 70 percent use rate of the device (e.g., five out of seven days) based on the log data.

Continuation of sensor use after one year may be considered when:

The CGMS has been previously approved by the health plan or the CGMS is in use prior to the user enrolling in the health plan.
There is documented evidence the member is compliant with his or her current CGMS device. Compliance is defined as at least 70 percent use rate of the device (e.g., five out of seven days) based on the log data.

All covered supplies must be compatible with the CGMS.

EXPERIMENTAL PROCEDURES

27447
27599
L8699

Basic benefit and medical policy

Patient-specific cutting guides and custom knee implants

Use of custom implants or patient-specific instrumentation (e.g., cutting guides) for joint arthroplasty, including, but not limited to, use in unicompartmental or total knee arthroplasty, is considered experimental. There is insufficient evidence in the peer-reviewed medical literature to determine the effects of the technology on health outcomes.

This policy is effective March 1, 2019.

64450**
64640**
64999**

**When specified as ablation of genicular nerves

Basic benefit and medical policy

Genicular nerve blocks

Genicular nerve blocks for the treatment of chronic knee pain (e.g., degenerative joint disease, osteoarthritis, treatment before knee replacement or after knee replacement or instead of knee replacement) are experimental. It hasn’t been scientifically demonstrated to improve patient clinical outcomes, effective March 1, 2019.

81313
81479
81539
81551
81599
88377
0005U
0021U

Basic benefit and medical policy

Genetic and protein biomarkers for the diagnosis and cancer risk assessment of prostate cancer

Genetic and protein biomarkers for the diagnosis and cancer risk assessment of prostate cancer are considered experimental. This includes, but is not limited to, the following:

Kallikrein markers (e.g., 4Kscore^™ Test)
Prostate Health Index (phi)
HOXC6 and DLX1 testing (e.g., SelectMDx)
PCA3, ERG, and SPDEF RNA expression in exosomes (e.g., ExoDx Prostate IntelliScore)
Autoantibodies ARF 6, NKX3-1, 5?-UTR-BMI1, CEP 164, 3?-UTR-Ropporin, Desmocollin, AURKAIP-1, CSNK2A2 (eg, Apifiny)
PCA3 testing (e.g., Progensa)
TMPRSS: ERG fusion genes
Gene hypermethylation testing (e.g., ConfirmMDx^®)
Mitochondrial DNA mutation testing (e.g., Prostate Core Mitomic Test^™)
Candidate gene panels
MiPS (Mi-ProstateScore)

Single-nucleotide variant testing for cancer risk assessment of prostate cancer is considered experimental.

This policy is effective March 1, 2019.

Facility

Here’s our hospital transfer policy

We’d like to remind you of Blue Cross Blue Shield of Michigan’s policy on transferring a patient from one hospital to another. When patients are discharged or transferred to another hospital, please indicate the appropriate discharge disposition as follows:

02 (Discharged or transferred to another short-term general hospital)
07 (Left against medical advice or discontinued care)

For electronic claims, discharge disposition is reported in Loop 2300 CL1-103 of the 837I transaction. For paper claims, use form locator 17 (patient discharge status) of the UB-04. The transferring hospital should receive full payment only when the patient’s length of stay meets or exceeds the maximum number of days allowed under the diagnosis-related group assigned to the admission.

If a patient is transferred to a second hospital before using all days allowed at the first hospital, the transferring hospital should receive only a per diem payment based on the length of stay.

Blue Cross reviews paid claims to identify patients who were discharged or transferred to another acute care facility. If we identify claims that should have been billed as transfers, we’ll adjust your payment.

For multiple transfers, refer to the article in the January 2010 Record.

Certain infusion drugs won’t be covered in outpatient hospitals, starting April 1

Approved authorizations are payable for the following professional locations:

Physicians’ offices or other health care providers’ offices
Ambulatory infusion centers
The member’s home, from a home infusion therapy provider

If your patient currently receives one of these infusions at a hospital outpatient facility:

Submit a prior authorization request for your patient to Blue Cross for a hospital outpatient facility. If this request isn’t submitted and approved, the patient will be responsible for the full cost of the medicine.
Find out where your patient can continue his or her infusion therapy. Check the directory of participating home infusion therapy providers and infusion centers. Please confirm network participation for your patient before his or her infusion.
Tell your patient to contact any of the listed infusion therapy providers. If the infusion therapy provider can accommodate your patient, they’ll work with you and your patient to make the change easy. We’re also sending this information to your patient.
Help your patient switch his or her infusion therapy to your office, infusion center or home infusion therapy provider by April 1.

For the ordering provider:

If a member must receive one of these infusions in a hospital outpatient facility, please follow the normal steps for a prior authorization request and include:

The authorization number previously approved
Rationale that clearly describes the reason the infusion must be administered in a hospital setting
Supporting chart notes

The medical drugs subject to this requirement include:

Drug name	HCPCS
Crysvita^®	J0584
Fasenra^™	J0517
Ilumya^™	J3245
Mepsevii^™	J3397
Radicava^®	J1301
Trogarzo^™	J1746

For more information about hospital outpatient infusion therapy, view previous issues of The Record:

2017
October
December

2018
March
June
September

2019
January

You can sign up to receive Blues Brief electronically

As announced in the January 2019 issue of The Record, Blues Brief has a new look and is now available by email subscription.

Why Blues Brief?
We know you’re very busy. Blues Brief offers a quick summary of several key articles that you can find in The Record and BCN Provider News.

Each month, provider consultants meet to select articles they want to make sure you don’t overlook. Summaries of these articles are then included in Blues Briefs with links to the full articles.

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Visit the subscription page to choose your preferred Blues Brief versions.

Here’s our hospital transfer policy

02 (Discharged or transferred to another short-term general hospital)
07 (Left against medical advice or discontinued care)

If a patient is transferred to a second hospital before using all days allowed at the first hospital, the transferring hospital should receive only a per diem payment based on the length of stay.

For multiple transfers, refer to the article in the January 2010 Record.

Pharmacy

Clarification: We’re removing providers on CMS preclusion list from our commercial and MA networks

For more information about the preclusion list, go to cms.gov** and type Preclusion list in the search box.

**Blue Cross Blue Shield of Michigan doesn’t own or control this website.

No portion of this publication may be copied without the express written permission of Blue Cross Blue Shield of Michigan, except that BCBSM participating health care providers may make copies for their personal use. In no event may any portion of this publication be copied or reprinted and used for commercial purposes by any party other than BCBSM.

*CPT codes, descriptions and two-digit numeric modifiers only are copyright 2018 American Medical Association. All rights reserved.