November 2020 Anthem Provider News and Important Updates -- Colorado

Contents

AdministrativeCommercialOctober 31, 2020

Digital transactions cut administrative tasks in half

AdministrativeCommercialOctober 31, 2020

Non-participating lab referrals

Medical Policy & Clinical GuidelinesCommercialOctober 31, 2020

Medical Policy and Clinical UM Guidelines notification letter (MAC)

Medical Policy & Clinical GuidelinesCommercialOctober 31, 2020

REMINDER: Post-service reviews using AIM

Reimbursement PoliciesCommercialOctober 31, 2020

Modifier Rules (Professional Reimbursement Policy) -- Update (MAC)

Reimbursement PoliciesCommercialOctober 31, 2020

Claims editing update for ICD-10-CM Excludes 1 notes

PharmacyCommercialOctober 31, 2020

IngenioRx Introduces New Pharmacy Network in 2021

PharmacyCommercialOctober 31, 2020

US Antibiotic Awareness Week

State & FederalMedicare AdvantageOctober 31, 2020

Preferred continuous glucose monitors

State & FederalMedicare AdvantageOctober 31, 2020

Provider Chat -- A fast, easy way to get your questions answered

State & FederalMedicare AdvantageOctober 31, 2020

Medical drug benefit Clinical Criteria updates -- June 2020

State & FederalMedicare AdvantageOctober 31, 2020

FDA approvals and expedited pathways used -- new molecular entities

State & FederalMedicare AdvantageOctober 31, 2020

Keep up with Medicare news

AdministrativeCommercialOctober 31, 2020

Working with Anthem Webinars -- November 2020 schedule: Blue High Performance Network (HPN)

We are continuing our series of “Working with Anthem” webinars for 2020.  These webinars are focused on one topic each session, and designed to help our providers and their staff learn how to use the tools currently available to improve operational efficiency when working with Anthem Blue Cross and Blue Shield (Anthem).


2020 Subject Specific Webinars -- November schedule

 

Topic: 

Blue High Performance Network (HPN)

Date/Time:

Wednesday, November 18, 2020, 12-1pm MT

Description:

Join our webinar to learn more about details such as:

- what is the Blue High Performance Network

- how do I know if I'm participating

- how to identify members aligned with this network

- sample member ID cards

- plus more

Registration link:

 

https://anthem.webex.com/anthem/onstage/g.php?PRID=b6a696587e498199466cadc7231c908d

 

Webinars are offered using Cisco WebEx. There is no cost to attend.  Access to the internet, an email address and telephone is all that's needed.  Attendance is limited, so please register today.

 

Watch for additional topics and dates in future issues of our monthly provider newsletter throughout the year.  We also will continue to offer our Fall Provider Seminars which will continue to cover a variety of topics in face-to-face and webinar options.

 

Recorded sessions: 

Most sessions are recorded and playback versions are available on our Registration Page.  The top portion of the page will show Upcoming Events and the bottom portion will show Event Recordings”.

 

Note:  Even if you are unavailable to attend, please register to ensure you receive the event recording password once available as it’s distributed to all that register. 

 

 

732-1120-PN-CO

AdministrativeCommercialOctober 31, 2020

Availity Attachment Tools for Anthem and Affiliate Payers -- Live Webinars

In this 60-minute webinar, you will learn how to use Availity's Attachment tools to submit and track supporting documentation electronically to Anthem and affiliate payers.

 

We will explore key workflow options to fit your organization’s needs, including how to:

 

  • Work a request in the inbox of your Attachments Dashboard.
  • Enter and submit a web claim including supporting documentation.
  • Use EDI batch options to trigger a request in your inbox.
  • Track attachments you submitted using sent and history lists in your Attachments Dashboard.
  • Get set up to use these tools.

 

As part of the session, we’ll answer questions and provide handouts and a job aid for you to reference later.

 

Register for an upcoming webinar session:

 

  1. In the Availity Portal, select Help & Training > Get Trained.
  2. The Availity Learning Center opens in a new browser tab.
  3. Search for and enroll in a session using one of these options:
    • In the Catalog, search by webinar title or keyword.
      • To find this specific live session quickly, use keyword medattach.
    • Select the Sessions tab to scroll the live session calendar.
  4. After you enroll, you’ll receive emails with instructions to join the session.

 

Webinar Dates:

 

DATE

DAY

TIME

October 7, 2020

Wednesday

4 p.m. to 5 p.m. ET

October 20, 2020

Tuesday

11 a.m. to noon ET

November 4, 2020

Wednesday

Noon to 1 p.m. ET

November 17, 2020

Tuesday

2 p.m. to 3 p.m. ET

December 4, 2020

Friday

3 p.m. to 4 pm.m ET 

December 15, 2020 

Tuesday

3 p.m. to 4 pm.m ET

 

 

762-1120-PN-CONV

AdministrativeCommercialOctober 31, 2020

Get the full picture of your patient’s health through their smartphone

Anthem Blue Cross and Blue Shield (Anthem) is committed to creating innovative tools that help simplify health care. In pursuit of that commitment, we recently enhanced our digital tool that enables members to share their personal health data with physicians and hospitals. This tool, referred to as My Health Record, or My Family Health Record, merges patient health records from providers who may have cared for an individual member and stores the data in one secure place that is accessible to the member via the Sydney Health mobile app and the member’s portal on anthem.com. My Health Record provides a new way for members to access their personal health information from multiple providers’ databases then view, download and share their health data and medical records with doctors via their smartphone or computer.

 

My Health Record allows members to share important health information with physicians, such as:

  • Lab results and historical insights with visualizations
  • Medications, Conditions, Immunizations, Vaccinations
  • Health records
  • Health records of dependents (14 years and under)
  • Easy access to provider information
  • Personalized health data tracking over time
  • Integration for member authorization to more health record data

 

The enhanced digital tool gives physicians and hospitals a holistic view of a member’s up-to-date health data. This complete health data in one trusted place enables providers and members to feel more confident in making important life decisions easily and quickly.

 

*This tool is now available to Anthem members in our Medicare, Individual, Small Group and Fully Insured Large Group business segments and will be available to members in our Large Group ASO and Anthem National Account business segments in early 2021.

 

 

763-1120-PN-CONV

 

AdministrativeCommercialOctober 31, 2020

Digital transactions cut administrative tasks in half

Introducing the Anthem Provider Digital Engagement Supplement to the provider manual

Using our secure provider portal or EDI submissions (via Availity), administrative tasks can be reduced by more than fifty percent when filing claims with or without attachments, checking statuses, verifying eligibility, benefits and when submitting prior authorizations electronically. In addition, it could not be easier. Through self-service functions, you can accomplish digital transactions all at one time, all in one place. If you are not already registered, visit the Availity EDI website or the secure provider portal via Availity.

 

Get payments faster

By eliminating paper checks, Electronic Funds Transfer (EFT) is a digital payment solution that deposits payments directly into your account. It is safe, secure and you can receive payments faster. Electronic remittance advice (ERA) is completely searchable and downloadable from the secure provider portal or the EDI 835 remittance, which meets all HIPAA mandates - eliminating the need for paper remittances.

 

Member IDs go digital

Anthem members are transitioning to digital member identification cards making it easier for them and you. The ID card is easily emailed directly to you for file upload, eliminating the need to scan or print. In addition, the new digital member ID card can be directly accessed through the secure provider portal via Availity. Providers should begin accepting the digital member ID cards when presented by the member. 

 

Anthem makes going digital easy with the Provider Digital Engagement Supplement

From our digital member identification cards to EDI transactions, application programming interfaces (APIs) to Direct Data Entry, we cover it all in our Provider Digital Engagement Supplement to the provider manual available here and on our secure provider portal through Availity. The Supplement outlines Anthem provider expectations, processes and self-service tools across all electronic channels, including medical, dental, and vision benefits.

 

The Provider Digital Engagement Supplement to the provider manual is another example of how Anthem is using digital technology to improve the health care experience. We are asking providers to go digital with Anthem no later than January 1, 2021, so we can realize our mutual goals of reducing administrative burden and increasing provider satisfaction and collaboration. Read the Digital Engagement Supplement now and go digital with Anthem.

 

 

774-1120-PN-CONV

 

 

AdministrativeCommercialOctober 31, 2020

Non-participating lab referrals

This is a reminder to ensure that you are referring Anthem members to participating labs. LabCorp is our preferred lab provider and offers a Single Source Solution to your testing needs.  The relationship with LabCorp does not affect network hospital-based lab service providers, contracted pathologists, or contracted independent laboratories.  Physicians may continue to refer to all par providers as they have in the past.

 

Not only does your Anthem agreement obligate you to refer to participating labs where available, but members will only receive their full benefits from participating providers.  As a result, referring your patient and our member to a non-participating lab may expose them to a greater financial responsibility.  As a reminder, Quest Diagnostics is a non-participating laboratory for all lines of business in Colorado. 

 

Unfortunately, there are certain non-participating labs that are offering to waive or cap co-payments, coinsurance or deductibles to our members in order to increase their overall revenue. These practices undermine member benefits and may encourage over-utilization of services.

 

These billing practices are also questionable in their legality.  Such a practice may present violations under state or federal anti-kickback laws, and may constitute abuse of health insurance under the Colorado criminal code. 

 

For a listing of Anthem participating laboratories, please check our online directory. Go to anthem.com, and select Providers.  Select your state if you haven’t done so already.  Under the Provider Resources heading, select Find a Doctor.  Select your state if you haven’t done so already. 

 

Note:  When searching for laboratory, pathology, or radiology services, under the field “I am looking for a:” select Lab/Pathology/Radiology; and then under the field “Who specializes in:”, select Laboratories, Pathology, or Radiology as appropriate for your inquiry.

 

LabCorp is our preferred lab provider and offers a Single Source Solution to your testing needs:

LabCorp is capable of providing services that range from routine testing, such as basic blood counts and cholesterol tests, to highly complex diagnosing of genetic conditions, cancers, and other rare diseases.  LabCorp has specialized laboratories which cover the following areas of testing:

                                                                         

· Allergy Program

· Cancer Testing

· Cardiovascular Disease

· Companion Diagnostics

· Dermatology

· Diabetes

· DNA Testing

· Endocrine Disorders

· Esoteric Coagulation

· Gastroenterology

· Genetic Testing

· Genetic Counseling

· Genomics

· HLA Lab for National Marrow Donor Program

· Hematopathology

· Infectious Disease

· Immunology

· Liver Disease

· Kidney Disease

· Medical Drug Monitoring

· Molecular Diagnostics

· Newborn Screening

· Pain Management

· Pathology Expertise w/range of Subspecialties

· Pharmacogenomics

· Preimplantation Genetic Diagnosis

· Reproductive Health

· Obstetrics / Gynecology

· Oncology

· Toxicology

· Whole Exome Sequencing

· Virology

· Women’s Health

· Urology

 

 

Note:  This relationship with LabCorp does not affect network hospital-based lab service providers, contracted pathologists, or contracted independent laboratories.

 

 

723-1120-PN-CONV

AdministrativeCommercialOctober 31, 2020

Clinical Laboratory Improvement Amendments (CLIA) Number -- Additional Information

The purpose of this article is to provide additional information regarding submission of the CLIA number on claims for laboratory services that include QW or 90 modifiers. As a reminder, claims filed without the CLIA number are considered incomplete and will reject. 

 

Both paper and electronic claim formats accommodate the CLIA number. 

 

  • On the CMS-1500 form, Box 23 (Prior Authorization) is reserved for the CLIA number.
  • On the 837P, REF segments are available: REF (X4) in loops 2300 and 2400, and REF (F4) in loop 2400. 

 

Note: The CLIA number for the Referring Clinical Laboratory should be included in REF (F4) 

 

The following examples illustrate how the CLIA number as well as procedure code modifiers QW and 90 should be filed:

 

Claim Format

Location(s) Reserved for Procedure Modifier and CLIA #

Modifier QW – diagnostic lab service is a CLIA waived test

·         CLIA Waived Tests - simple laboratory examinations and procedures that have an insignificant risk of an erroneous result

CMS-1500

Procedure modifier ‘QW’:

Box 24d

CLIA #:

Box 23 Prior Authorization

837P

Procedure modifier ‘QW’:

Loop 2400 SV101-3 (1st position)

CLIA #:

Loop 2300 or 2400 REF X4

Modifier 90 – Reference (Outside) Laboratory

·         Referring laboratory – refers a specimen to another laboratory for testing

·         Reference laboratory – receives a specimen from another laboratory and performs one or more tests on that specimen

CMS-1500

Procedure modifier ‘90’:

Box 24d

CLIA #:

Box 23 Prior Authorization

837P

Procedure modifier ‘90’:

Loop 2400 SV101-3 – SV101-6

CLIA #:

Loop 2300 or 2400 REF X4

CLIA # - Referring Facility Identification:

Loop 2400 REF F4

 

Additional information regarding CLIA is available on the CMS website:  https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/

 

If you have additional questions, please call the telephone number on the back of the member’s identification card.

 

 

733-1120-PN-CONV

Medical Policy & Clinical GuidelinesCommercialOctober 31, 2020

Medical Policy and Clinical UM Guidelines notification letter (MAC)

Medical Policy & Clinical GuidelinesCommercialOctober 31, 2020

REMINDER: Post-service reviews using AIM

As previously communicated in October 2017 Network Update, Anthem, uses AIM to administer pre-service clinical reviews for services noted below.  AIM reviews requests in real time against evidence-based clinical guidelines and Anthem medical policies.  Providers are notified via letter or remit message when claims are submitted without the appropriate pre-service review by AIM.  If such a letter or message is received, providers will need to obtain a post-service clinical review for the service via the AIM ProviderPortalSM.  If documentation / post-service review request is submitted to Anthem, Providers are notified via another letter or remit message to submit to AIM.

 

To help prevent delays in claim processing and post-service reviews, ordering providers submit pre-service request to AIM in one of the following ways:

  • Access AIM ProviderPortal directly at providerportal.com available 24/7 to process orders in real-time
  • Access AIM via the Availity web portal at availity.com

As a reminder, AIM reviews the following services for clinical appropriateness:

  • Advanced diagnostic imaging
  • Cardiology tests and procedures (e.g. MPI, echocardiography, PCI, cardiac catheterization)
  • Medical oncology treatments through the Cancer Care Quality Program
  • Radiation oncology treatments (e.g. IMRT, brachytherapy)
  • Sleep testing, treatment and supplies
  • Genetic testing
  • Musculoskeletal (e.g., spine and joint surgeries, pain management)
  • Rehabilitative services (physical, speech and occupational therapy)
  • Surgical Site of Care (e.g., gastroenterology, other surgeries will be implemented which will be communicated via provider newsletter)

Services performed in an emergency or inpatient setting are excluded from AIM programs.

 

This update applies to local fully-insured Anthem members and members who are covered under a self-insured (ASO) benefit plan, with services medically managed by AIM. It does not apply to BlueCard, Medicare Advantage, Medicaid, Medicare Supplement, Federal Employee Program (FEP).

 

For more information please contact the phone number on the back of the member ID card.

 

 

711-1120-PN-CONV

Reimbursement PoliciesCommercialOctober 31, 2020

Documentation Standards for Episodes of Care (Professional Reimbursement Policy) -- New (MAC)

Reimbursement PoliciesCommercialOctober 31, 2020

Modifier Rules (Professional Reimbursement Policy) -- Update (MAC)

Reimbursement PoliciesCommercialOctober 31, 2020

Bundled Services and Supplies (Professional Reimbursement Policy) – Update (MAC)

Reimbursement PoliciesCommercialOctober 31, 2020

Claims editing update for ICD-10-CM Excludes 1 notes

Beginning with dates of service on or after November 1, 2020 Anthem will be implementing revised claims editing logic tied to Excludes 1 notes from ICD-10-CM 2020 coding guidelines.  To help ensure the accurate processing of claims, use ICD-10-CM Coding Guidelines when selecting the most appropriate diagnosis for member encounters. Please remember to code to the highest level of specificity. For example, if there is an indication at the Category level that a code can be billed with another range of codes, it is imperative to look for Excludes 1 notes that may prohibit billing a specific code combination.

 

For assistance in determining proper coding guidance, the following site should be helpful: https://www.cdc.gov/nchs/icd/icd10cm.htm

 

One of the unique attributes of the ICD-10 code set and coding conventions is the concept of Excludes 1 notes. An Excludes 1 note indicates that the excluded code identified in the note should not be billed with the code or code range listed above the Excludes 1 note. These notes appear below the affected codes – if the note appears under the Category (first three characters of a code), it applies to the entire series of codes within that category.  If the Excludes 1 note appears beneath a specific code (3, 4, 5, 6 or 7 characters in length) then it applies only to that specific code 

 

  • Reporting Z01.419 with Z12.4
    • 41X (encounter GYN exam w/out abnormal findings) has an Excludes 1 note below that includes Z12.4.
    • 4 (encounter for screening malignant neoplasm cervix)
  • Reporting Z79.891with F11.2X
    • 891 (long-term use of Opiates) has an Excludes 1 note after it for F11.2X. F11.2X (Opioid dependence)
  • Reporting M54.2 with M50.XX
    • 2 (Cervicalgia) has an Excludes 1 note below it for M50.XX (cervicalgia due to intervertebral disc disorder)
  • Reporting M54.5 with S39.012X and/or M54.4x
    • 5 (low back pain) has an Excludes 1 note below it which includes; S93.012X (strain of muscle, fascia and tendon of lower back), M54.4X (low back pain) M51.2X (lumbago due to intervertebral disc disorder)
  • Reporting J03.XX with J02.XX, J35.1, J36, J02.9
    • - (Acute tonsillitis) has an Excludes 1 note below it which includes; J02.- (acute sore throat), J35.1 (hypertrophy of tonsils), J36 (Peritonsillar abscess)
  • Reporting N89 with R87.62X, D07.2, R87.623, N76.XX, N95.2, 00
    • N89 (Other inflammatory disorders of the vagina) has an Excludes 1 note below the category for
    • 62X(abnormal results from vaginal cytological exam), D07.2 (vaginal intraepithelial neoplasia),
    • 623(HGSIL of vagina), N76.XX inflammation of the vagina), N95.2 (senile [atrophic] vaginitis),
    • 00 (trichomonal leukorrhea)

 

Finally, if you believe an Excludes1 note denial is incorrect, please consult the ICD-10-CM codebook to verify appropriate use of the billed codes and provide supporting documentation through the normal dispute process as to why the billed diagnoses codes are appropriately used together.

 

 

752-1120-PN-CONV

PharmacyCommercialOctober 31, 2020

Anthem prior authorization updates for specialty pharmacy are available (MAC)

PharmacyCommercialOctober 31, 2020

IngenioRx Introduces New Pharmacy Network in 2021

Starting January 1, 2021, IngenioRx, the pharmacy benefit manager for our affiliated health plans, will make its new standard pharmacy network available to your patients. The standard network will be made up of about 58,000 pharmacies nationwide, including well-known national chains like Costco, CVS, Kroger, Sam’s Club, Target and Walmart.

 

With robust access, your patients can use any participating pharmacy across the country in the standard network to fill their prescriptions.

 

Network Notification Plan

Some of your patients covered by an Anthem Blue Cross and Blue Shield (Anthem) health plan may currently use pharmacies that are not in this new network. They’ll need to transfer their active prescription(s) to a network pharmacy to ensure there is no interruption of their coverage.

 

Prior to the network effective date, we’ll notify your patients by letter outlining the easy steps about transferring their prescriptions to another pharmacy in the network.

 

In addition, to help you easily send prescriptions to a participating pharmacy, we’ll include messaging via your patients’ electronic medical record. This message will appear if you attempt to submit a prescription to a pharmacy that’s not included in the standard network. This will ensure your patients’ prescriptions are properly routed to a network pharmacy and will help them continue to receive their medications worry-free.

 

If your patients would like to search for a network pharmacy prior to the new network effective date, they can log in to their member portal at anthem.com, where instructions will appear with a helpful link to our online pharmacy search tool. They can enter their address/city/state or their zip code to begin searching.

 

Questions?

Please refer to our helpful Frequently Asked Questions for more details about the new standard network.

 

 

750-1120-PN-CONV

 

PharmacyCommercialOctober 31, 2020

US Antibiotic Awareness Week

US Antibiotic Awareness Week is November 18-24, 2020!  This is a one week observance that gives organizations and providers an opportunity to raise awareness on the appropriate use of antibiotics and reduce the threat of antibiotic resistance. The Centers for Disease Control and Prevention (CDC) has over 10 hours of free Continuing Education available for providers.

 

The CDC promotes Be Antibiotics Aware, an educational effort to raise awareness encouraging safe antibiotic prescribing practices and use. Be Antibiotics Aware has many resources for health care professionals (in outpatient and inpatient settings) including videos such as The Right Tool and Antibiotics Aren’t Always the Answer that can be utilized in provider’s waiting rooms. 

 

 

647-1020-PN-CONV

 

State & FederalMedicare AdvantageOctober 31, 2020

Preferred continuous glucose monitors

On January 1, 2020, Anthem Blue Cross and Blue Shield (Anthem) implemented a preferred edit on Medicare Part B eligible continuous glucose monitors (CGMs). The preferred CGM is Freestyle Libre.

 

Preferred CGM edits do not apply to the following plans/plan types:

  • Employer Group Waiver Plans (EGWP) Medicare Advantage Part D (MAPD) through Anthem
  • Employer Group Waiver Plans (EGWP) Medicare Advantage (MA only) through Anthem
  • Individual Medicare Advantage Plans (MA only) through Anthem

 

Delivery channels

Only members enrolled in a plan using preferred CGM edits will need to obtain their CGM systems from a retail or mail order pharmacy. Members on a plan without preferred CGM edits will be able to obtain their CGM systems through durable medical equipment (DME) providers in addition to retail and mail order pharmacies. Please check member and plan benefits to confirm the available delivery channels for accessing CGM products.

 

 

ABSCARE-0664-20

State & FederalMedicare AdvantageOctober 31, 2020

Provider Chat -- A fast, easy way to get your questions answered

You now have a new option to have questions answered quickly and easily. With Anthem Blue Cross and Blue Shield (Anthem) and AMH Health, LLC Chat, providers can have a real-time, online discussion through a new digital service, available through Payer Spaces on Availity.*

 

Provider Chat offers:

  • Faster access to Provider Services for all questions.
  • Real-time answers to your questions about prior authorization and appeals status, claims, benefits, eligibility, and more.
  • An easy to use platform that makes it simple to receive help.
  • The same high level of safety and security you have come to expect with Anthem and AMH Health.

 

Chat is one example of how Anthem and AMH Health are using digital technology to improve the health care experience, with the goal of saving valuable time. To get started, access the service through Payer Services on Availity.

 

 

* Availity, LLC is an independent company providing administrative support services on behalf of Anthem Blue Cross and Blue Shield and AMH Health, LLC.

 

 

ABSCARE-0683-20

State & FederalMedicare AdvantageOctober 31, 2020

Medical drug benefit Clinical Criteria updates -- June 2020

On February 21, 2020, May 15, 2020, and June 18, 2020, the Pharmacy and Therapeutics (P&T) Committee approved Clinical Criteria applicable to the medical drug benefit for Anthem Blue Cross and Blue Shield. These policies were developed, revised or reviewed to support clinical coding edits.

 

The Clinical Criteria is publicly available on the provider websites, and the effective dates will be reflected in the Clinical Criteria Web Posting June 2020. Visit Clinical Criteria to search for specific policies.

           

If you have questions or would like additional information, use this email.

 

 

ABSCRNU-0173-20

State & FederalMedicare AdvantageOctober 31, 2020

FDA approvals and expedited pathways used -- new molecular entities

Anthem Blue Cross and Blue Shield (Anthem) reviews the activities of the FDA’s approval of drugs and biologics on a regular basis to understand the potential effects for both our providers and members.

 

The FDA approves new drugs/biologics using various pathways of approval. Recent studies on the effectiveness of drugs/biologics going through these different FDA pathways illustrates the importance of clinicians being aware of the clinical data behind a drug or biologic approval in making informed decisions.

 

Here is a list of the approval pathways the FDA uses for drugs/biologics:

  • Standard Review: The Standard Review process follows well-established paths to make sure drugs/biologics are safe and effective when they reach the public. From concept to approval and beyond, FDA performs these steps: reviews research data and information about drugs and biologics before they become available to the public, watches for problems once drugs and biologics are available to the public, monitors drug/biologic information and advertising, and protects drug/biologic quality. To learn more about the Standard Review process, go here.
  • Fast Track: Fast Track is a process designed to facilitate the development and expedite the review of drugs/biologics to treat serious conditions and fill an unmet medical need. To learn more about the Fast Track process, go here.
  • Priority Review: A Priority Review designation means FDA’s goal is to take action on an application within six months. To learn more about the Priority Review process, go here.
  • Breakthrough Therapy: A process designed to expedite the development and review of drugs/biologics that may demonstrate substantial improvement over available therapy. To learn more about the Breakthrough Therapy process, click here.
  • Orphan Review: Orphan Review is the evaluation and development of drugs/biologics that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. To learn more about the Orphan Review process, click here.
  • Accelerated Approval: These regulations allowed drugs/biologics for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint. To learn more about the Accelerated Approval process, click here.

 

New molecular entities approvals — January to August 2020

Certain drugs/biologics are classified as new molecular entities (NMEs) for purposes of FDA review. Many of these products contain active ingredients that have not been approved by FDA previously, either as a single ingredient drug or as part of a combination product; these products frequently provide important new therapies for patients.

 

Anthem reviews the FDA-approved NMEs on a regular basis. To facilitate the decision-making process, we are providing a list of NMEs approved from January to August 2020, along with the FDA approval pathway utilized.

 

Generic name

Trade name

Standard
Review

Fast Track

Priority Review

Break-through Therapy

Orphan Review

Accelerated Approval

Approval date

Indication

Abametapir

Xeglyze

X

 

 

 

 

 

July 24, 2020

Head lice

Amisulpride

Barhemys

X

 

 

 

 

 

February 26, 2020

Postoperative nausea and vomiting

Avapritinib

Ayvakit

 

X

X

X

X

 

January 9, 2020

PDGFRa exon 18 mutant gastrointestinal stromal tumor

Belantamab mafodotin

Blenrep

 

 

 X

X

X

X

August 5, 2020

Multiple myeloma

Bempedoic acid

Nexletol

X

 

 

 

 

 

February 21, 2020

Dyslipidemia

Brexucabtagene autoleucel

Tecartus

 

 

X

X

X

X

July 24, 2020

Mantle cell lymphoma

Capmatinib

Tabrecta

 

 

X

X

X

X

May 6, 2020

Non-small cell lung cancer (NSCLC)

Decitabine/ cedazuridine

Inqovi

 

 

X

 

X

 

July 7, 2020

Myelodysplastic syndromes

Eptinezumab-jjmr

Vyepti

X

 

 

 

 

 

February 21, 2020

Migraine prevention

Fostemsavir

Rukobia

 

X

X

X

 

 

July 2, 20202

HIV treatment

Inebilizumab

Uplizna

X

 

 

X

X

 

June 11, 2020

Neuromyelitis optica spectrum disorder

Isatuximab

Sarclisa

X

 

 

 

X

 

March 2, 2020

Multiple myeloma

Lurbinectedin

Zepzelca

 

 

X

 

X

X

June 15, 2020

NSCLC

Nifurtimox

Lampit

 

 

X

 

X

X

August 6, 2020

Chagas disease

Oliceridine

Olinvyk

X

X

 

 

 

 

August 7, 2020

Moderate to severe acute pain

Opicapone

Ongentys

X

 

 

 

 

 

April 24, 2020

Parkinson’s disease

Osilodrostat

Isturisa

X

 

 

 

X

 

March 6, 2020

Cushing’s disease

Ozanimod

Zeposia

X

 

 

 

 

 

March 25, 2020

Multiple sclerosis

Peanut (Arachis hypogaea) allergen powder-dnfp

Palforzia

X

X

 

X

 

 

January 31, 2020

Peanut allergy

Pemigatinib

Pemazyre

 

 

X

X

X

X

April 17, 2020

Cholangiocarcinoma

Remimazolam

Byfavo

X

 

 

 

 

 

April 2, 20202

Sedation for procedures

Rimegepant

Nurtec ODT

 

 

X

 

 

 

February 27, 2020

Migraine treatment

Risdiplam

Evrysdi

 

X

X

X

X

 

August 7, 2020

Spinal muscular atrophy

Ripretinib

Qinlock

 

X

X

X

X

 

May 15, 2020

Gastrointestinal stromal tumor

Sacituzumab-hziy

Trodelvy

 

X

X

X

X

X

April 22, 2020

Triple negative breast cancer

Selpercatinib

Retevmo

 

 

X

X

X

X

May 8, 2020

NSCLC and thyroid cancers

Selumetinib

Koselugo

 

X

X

X

X

 

April 10, 2020

Neurofibromatosis type 1

Tafasitamab

Monjuvi

X

X

 

X

X

X

July 31, 2020

Large B-cell lymphoma

Tazemetostat

Tazverik

 

 

X

 

X

X

January 23, 2020

Epithelioid sarcoma

Teprotumumab-trbw

Tepezza

 

X

X

X

X

 

January 21, 2020

Thyroid eye disease

Triheptanoin

Dojolvi

X

X

 

 

X

 

June 30, 2020

Long-chain fatty acid oxidation disorders

Tucatinib

Tukysa

 

X

X

X

X

 

April 17, 2020

Breast cancer

Viltolarsen

Viltepso

 

X

X

 

X

X

August 12, 2020

Duchenne muscular dystrophy

Source: www.fda.gov

 

 

ABSCRNU-0178-20

State & FederalMedicare AdvantageOctober 31, 2020

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