 Provider News MissouriNovember 2020 Anthem Provider News - MissouriIn 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:
- In the Availity Portal, select Help & Training > Get Trained.
- The Availity Learning Center opens in a new browser tab.
- 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.
- After you enroll, you’ll receive emails with instructions to join the session.
Webinar Dates
Date
|
Day
|
Time
|
November 4, 2020
|
Wednesday
|
12 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 p.m. ET
|
December 15, 2020
|
Tuesday
|
3 p.m. to 4 p.m. ET
|
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.
If you have additional questions, please call the telephone number on the back of the member’s identification card.
Introducing the Anthem Blue Cross and Blue Shield (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 50 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, please 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, APIs to Direct Data Entry, we cover it all in our Provider Digital Engagement Supplement to the provider manual and on the secure Availity Provider Portal. 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 Provider Digital Engagement Supplement now and go digital with Anthem.
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 Records, 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 anthem.com. My Health Records 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 Records 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.
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 at https://www.cdc.gov/antibiotic-use/community/for-hcp/continuing-education.html.
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.
Medical policy updates
The following Anthem Blue Cross and Blue Shield new medical polices were reviewed on August 13, 2020 for Indiana, Kentucky, Missouri, Ohio and Wisconsin.
NOTE *Precertification required
Title
|
Information
|
Effective date
|
MED.00134 Non-invasive Heart Failure and Arrhythmia Management and Monitoring System
|
• The use of a non-invasive heart failure and arrhythmia management and monitoring system (for example, µ-Cor™ Heart Failure and Arrhythmia Management System) is considered Investigational and Not Medically Necessary (INV&NMN) for all indications.
- Existing codes 0607T, 0608T (which were effective 07/01/2020) will be considered INV&NMN for all indications
|
2/1/2021
|
SURG.00156 Implanted Artificial Iris Devices
|
• The use of implanted artificial iris devices is considered INV&NMN for all indications, including as a treatment of congenital or traumatic aniridia
-Existing codes 0616T, 0617T, 0618T (effective 07/01/20), C1839, 08RC3JZ, and 08RD3JZ will be considered INV&NMN for all indications
|
2/1/2021
|
*SURG.00157 Minimally Invasive Treatment of the Posterior Nasal Nerve to Treat Rhinitis
|
• Minimally invasive treatment of the posterior nasal nerve area, such as cryotherapy or radiofrequency therapy, to decrease the symptoms of allergic or nonallergic rhinitis is considered INV&NMN in all cases
- No specific code for cryotherapy or RF treatment of nasal tissue for rhinitis; listed 30999 (NOC) and 30117 if billed for this diagnosis, considered INV&NMN
|
2/1/2021
|
Clinical guideline updates
The following clinical guideline has been adopted by Anthem Blue Cross and Blue Shield for Indiana, Kentucky, Missouri, Ohio and Wisconsin.
NOTE *Precertification required
Title
|
Information
|
Effective date
|
* CG-SURG-104 Intraoperative Neurophysiological Monitoring
|
This Clinical Guideline addresses the various types of evoked response studies and their use in intraoperative neurophysiological monitoring when the monitoring is not provided by a member of the operating team. The use of neural evoked response studies for purposes other than assistance during a surgical procedure is not addressed in this document.
Applicable Codes:
- CPT codes: 95829, 95940, 95941
- HCPCS: G0453
- ICD10 procedure codes: 4A1004G-4A10X4G, 4A1104G-4A11X4G
|
2/1/2021
|
In the October 2020 edition of Provider News, we announced updates to prior authorizations that applied to Commercial Individual business effective January 1, 2021. Please be advised that the prior authorization updates apply to all Commercial local business, including individual and group business. Also, the effective date of these updates is now February 1, 2021.
Please see below for the complete updated notice.
Anthem Blue Cross and Blue Shield in Indiana, Kentucky, Missouri, Ohio and Wisconsin is committed to reducing costs that are not medically necessary while improving health outcomes. To that end, effective February 1, 2021 Anthem Blue Cross and Blue Shield in Indiana, Kentucky, Missouri, Ohio and Wisconsin will require prior authorization for all of our commercial local business.
The following codes will require prior authorization with a date of service on or after February 1, 2021 for all of our commercial local business:
Medical Policy or
Clinical Guideline
|
Code(s)
|
CG-SURG-70 SURG.00026 SURG.00007
|
C1767
|
The following Clinical Guidelines have been adopted for all of our Commercial local business in Indiana, Kentucky, Missouri, Ohio and Wisconsin and will require prior authorization on or after February 1, 2021.
Clinical Guideline
|
Code
|
CG-DME-13
|
L5987
|
CG-DME-42
|
A9274, E0784, E0787, S1034
|
CG-DME-47
|
E0466, E0467
|
CG-OR-PR-04
|
S1040, L0112
|
CG-SURG-86
|
34705, 34841, 34842, 34843, 34844, 34845, 34846, 34847, 34848
|
The following Medical Policies have been reviewed and will require prior authorization for all of our Commercial local business in Indiana, Kentucky, Missouri, Ohio and Wisconsin, on or after February 1, 2021.
Medical Policy or
Clinical Guideline
|
Code
|
GENE.00054
|
0157U, 0158U, 0159U, 0160U, 0161U,
|
SURG.00121
|
33477
|
SURG.00010
|
53445, 53447
|
LAB.00016
|
81599
|
GENE.00011
|
81599
|
GENE.00037
|
81599
|
GENE.00020
|
81599
|
GENE.00016
|
81599
|
GENE.00018
|
81599
|
LAB.00019
|
81599
|
GENE.00023
|
81599
|
GENE.00009
|
81599
|
GENE.00026
|
81599
|
GENE.00052
|
81599
|
SURG.00007
|
C1767
|
CG-DME-44
|
E0766, A4555
|
GENE.00054
|
0157U, 0158U, 0159U, 0160U, 0161U
|
CG-SURG-95
|
C1767
|
SURG.00121
|
33477
|
As previously communicated in the October 2017 Network Update, Anthem Blue Cross and Blue Shield (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.
The new professional reimbursement policy for Documentation Standards for Episodes of Care will be effective February 1, 2021. This policy will replace the current Documentation Guidelines for Adaptive Behavior Assessments and Treatment for Autism Spectrum Disorder and Documentation Guidelines for Central Nervous System Assessments and Tests policies. Those policies will be retired as of February 1, 2021. The Documentation Standards for Episodes of Care policy will be considered an administrative policy and will serve as an overarching documentation standards policy.
For more information about this policy, visit the Reimbursement Policies webpage for your state: Indiana, Kentucky, Missouri, Ohio, Wisconsin.
Beginning with dates of service on or after February 1, 2021, Anthem Blue Cross and Blue Shield (Anthem) will update Bundled Services and Supplies Section 2 Coding list to indicate that the following codes:
- 43281 - laparoscopy, surgical, repair of paraesophageal hernia, includes fundoplasty, when performed; without implantation of mesh,
- 43282 - laparoscopy, surgical, repair of paraesophageal hernia, includes fundoplasty, when performed; with implantation of mesh or other prosthesis,
- 43283 - laparoscopy, surgical, esophageal lengthening procedure,
- 43332 - repair paraesophageal hiatal hernia, via laparotomy, except neonatal; without implantation of mesh or other prosthesis, and
- 43333 - repair paraesophageal hiatal hernia, via laparotomy, except neonatal; with implantation of mesh or other prosthesis,
are not eligible for separate reimbursement when reported with bariatric procedure codes 43644, 43645, 43770, 43771, 43772, 43773, 43774, 43775, 43842, 43843, 43845, 43846, 43847, 43848, 43886, 43887 and 43888.
Additionally, the Bundled Services Section 2 coding list will be updated to include the telehealth originating site facility fee HCPCS code (Q3014) when reported with an E&M code in place of service 11.
For more information about this policy, visit the Reimbursement Policies webpage for your state: Indiana, Kentucky, Missouri, Ohio, Wisconsin.
Beginning with dates of service on or after February 1, 2021, Anthem Blue Cross and Blue Shield (Anthem) policy language has been updated to add Modifier FB to the related coding section and indicate that when used in the adjudication of a claim reimbursement may be affected.
Modifier FB is defined as an item provided without cost to provider, supplier or practitioner, or full credit received for replaced device.
For more information about this policy, visit the Reimbursement Policies webpage for your state: Indiana, Kentucky, Missouri, Ohio, Wisconsin.
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 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 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 below for more details about the new standard network.
Frequently Asked Questions
Q: What is the standard pharmacy network?
A: The standard pharmacy network is being added to the IngenioRx network portfolio, beginning January 1, 2021. The standard pharmacy network will be made up of approximately 58,000 pharmacies nationwide, including well-known national retailers and big-box stores. These include Costco, CVS, Kroger, Sam’s Club, Target and Walmart.
Q: How will my patients who have used a non-network pharmacy and are moving to the standard pharmacy network be notified?
A: Prior to January 1, we’ll notify your patients who are currently utilizing a pharmacy that will not be part of the standard network on the effective date via letter. The information will help patients easily transfer their prescriptions to a participating network pharmacy with no interruption when they need to fill their prescriptions.
Q: How will I be notified if an ePrescription is routed to a non-network pharmacy?
A: An alert will be provided to you via your patients’ electronic medical records if you attempt to forward a prescription to a pharmacy that doesn’t participate in the standard network. This will ensure your patients’ prescriptions are properly routed to a network pharmacy and this will help them seamlessly receive their medications.
Q: If I’m alerted through my patients’ electronic medical record that a pharmacy will not be part of the standard network, how can my patient move their prescription to another participating pharmacy?
A: You can choose another pharmacy in the patient’s EMR where the ePrescription will be routed, or your patient can take a printed copy of your prescription to the new pharmacy of their choosing and ask the new pharmacy to contact the non-network pharmacy to make arrangements for the transfer.
Q: How can my patients search for a pharmacy that participates in the standard pharmacy network? A: Starting in November 2020, your patients can log in to anthem.com, where information about their new pharmacy network will appear. The information will also outline how to transfer prescriptions to a network pharmacy with a helpful link to our online pharmacy search tool. They can enter their address/city/state or their zip code to begin searching.
Q: Can my patients obtain maintenance medications at a standard network pharmacy?
A: While pharmacies in the standard network often fill prescriptions for both acute and maintenance medications, we encourage your patients who will be moving to the standard network in 2021 to use home delivery or their 90-day retail benefit after January 1, 2021, such as Retail 90 or Rx Maintenance 90, depending on their benefit design, to fill prescriptions for maintenance medications and possibly save on their out-of-pocket cost.
Q: If my patients have questions about the new standard pharmacy network or need help with having their prescriptions transferred, whom should they contact?
A: If your patients have questions, they can call Pharmacy Member Services at the phone number on their member ID card.
Prior authorization updates
Effective for dates of service on and after February 1, 2021, the following specialty pharmacy codes from current or new clinical criteria documents will be included in our prior authorization review process.
Please note, inclusion of National Drug Code (NDC) code on your claim will help expedite claim processing of drugs billed with a Not Otherwise Classified (NOC) code.
To access the Clinical Criteria information, click here.
Anthem Blue Cross and Blue Shield (Anthem)’s prior authorization clinical review of non-oncology specialty pharmacy drugs will be managed by Anthem’s medical specialty drug review team. Review of specialty pharmacy drugs for oncology indications will be managed by AIM Specialty Health® (AIM), a separate company and are shown in italics in the table below.
Clinical Criteria
|
HCPCS or CPT Code(s)
|
Drug
|
*ING-CC-0127
|
J9999, C9399
|
Darzalex Faspro
|
* Non-oncology use is managed by Anthem’s medical specialty drug review team. Oncology use is managed by AIM.
Step therapy updates
Effective for dates of service on and after February 1, 2021, the following specialty pharmacy codes from current or new clinical criteria documents will be included in our existing specialty pharmacy medical step therapy review process.
To access the Clinical Criteria information related to Step Therapy, click here.
Anthem’s prior authorization clinical review of non-oncology specialty pharmacy drugs will be managed by Anthem’s medical specialty drug review team. Review of specialty pharmacy drugs for oncology indications will be managed by AIM Specialty Health® (AIM), a separate company and are shown in italics in the table below.
Clinical Criteria
|
Status
|
Drug(s)
|
HCPCS Codes
|
ING-CC-0160
|
Non-preferred
|
Vyepti
|
J3032
|
ING-CC-0160
|
Non-preferred
|
Vyepti
|
C9063
|
ING-CC-0011
|
Non-preferred
|
Ocrevus
|
J2350
|
* Non-oncology use is managed by Anthem’s medical specialty drug review team. Oncology use is managed by AIM.
Correction to a prior authorization update
In the October 2020 edition of Provider News, we published a prior authorization update regarding clinical criteria ING-CC-0174 on the drug Kesimpta.
- One HCPCS code has been added, J9302. This is the valid code for the drug Kesimpta.
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.
Introducing the Anthem Blue Cross and Blue Shield (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 50 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, please 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 will deliver payments to you faster. Electronic remittance advice (ERA) is completely searchable and downloadable from the Availity Provider Portal or the EDI 835 remittance, which meets all HIPAA mandates — eliminating the need for paper remittances.
Member ID cards go digital
Members who are transitioning to digital member ID cards, will find it is 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 ID cards, EDI transactions, application programming interfaces and direct data entry, we cover everything you need to know in the Provider Digital Engagement Supplement to the provider manual, available at https://www.anthem.com/medicareprovider > select your state > Providers > Policies, Guidelines & Manuals, and on the secure Availity Provider Portal. The supplement outlines our provider expectations, processes and self-service tools across all electronic channels Medicaid and Medicare, 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 Provider Digital Engagement Supplement now by going to https://www.anthem.com/medicareprovider > select your state > Providers > Policies, Guidelines & Manuals. Go digital with Anthem.
* Availity, LLC is an independent company providing administrative support services on behalf of Anthem Blue Cross and Blue Shield.
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:
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: fda.gov
|