Drug Alerts and Special Reports

Key reimbursement alerts for office-administered drugs — C-Code, J-Code, NDC, and NCCN alerts plus pricing updates, sent on behalf of pharma manufacturers.

Subscribe To Newsletter

FDA Approved 10/02/2023

Now Approved: The Latest Treatment For Some Adults With Late-Onset Pompe Disease - 10/02/23

NOW APPROVED: Amicus Therapeutics is pleased to inform you that POMBILITI™ in combination with OPFOLDA™ has been approved for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). Please see full Prescribing Information, including BOXED WARNING, for POMBILITI and full Prescribing Information for OPFOLDA , also available at PombilitiOpfoldaHCP.com . POMBILITI (cipaglucosidase alfa-atga) for injection, for intravenous use, a bis-M6P enriched enzyme, in combination with OPFOLDA (miglustat) 65 mg capsules for oral use, an oral enzyme stabilizer, is the first and only 2-component therapy in late-onset Pompe disease and is designed to maximize enzyme activity. Late-onset Pompe disease (LOPD) is a rare, hereditary, progressive disorder that is usually characterized by limb-girdle muscle weakness and/or respiratory insufficiency. LOPD is…

J-Code 09/29/2023

Permanent J-Code for ZYNYZ™ (retifanlimab-dlwr): Available October 1st, 2023

Effective for claims on or after October 1, 2023: J9345 Injection, retifanlimab-dlwr, 1 mg ZYNYZ is indicated for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. PRODUCT SPECIFICATIONS: HCPCS Code J9345 HCPCS Code Descriptor Injec tion, retifanlimab-dlwr, 1 mg NDC Number 10-digit: 50881-006-03 11-digit: 50881-0006-03 WAC Pricing Per Unit $712 per unit WAC Pricing Per Package $14,240 per package For billing and coding or reimbursement questions, or to request support from a Field Access Manager, Call 1-855-452-5234, Monday - Friday 8 AM to 8 PM ET Visit the ZYNYZ HCP website IMPORTANT SAFETY INFORMATION Severe and Fatal Immune-Mediated Adverse Reactions Important immune-mediated adverse…

Pricing 09/28/2023

Important Price Change Announcement for Photrexa® - 9/28/23

This email is being sent by BuyandBill.com on behalf of Glaukos ® , Inc. Announcing New Pricing for Photrexa ® Cross-Linking Kit As of October 1, 2023 Item Code/Price Description HCPCS Code J2787 Riboflavin 5'-phosphate, ophthalmic solution, up to 3 ml NDC Number 25357-0025-03 A cross linking kit contains one Photrexa Viscous 3 ml single-patient use syringe and one Photrexa solution 3 ml single-patient use syringe, each in an individual foil pouch New WAC Pricing* $4,150 per kit *Wholesale Acquisition Cost listed in Redbook effective 10/1/23 New WAC Pricing* $2,075 per HCPCS Unit *Wholesale Acquisition Cost listed in Redbook effective 10/1/23 We are respectfully requesting that you update your claims processing system, and fee schedules for PHOTREXA for all claims on or after October 1, 2023 IMPORTANT SAFETY INFORMATION INDICATIONS Photrexa® Viscous (riboflavin 5'-phosphate in 20% dextran ophthalmic solution) and Photrexa® (riboflavin 5'-phosphate ophthalmic solution) are indicated…

J-Code 09/19/2023

Permanent J-Code for REZZAYO™ (rezafungin for injection): Effective October 1, 2023 - 9/19/23

REZZAYO™ (rezafungin for injection) is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasiv Effective for claims on or after October 1, 2023: J0349 Injection, rezafungin, 1 mg REZZAYO TM (rezafungin for injection) is an echinocandin antifungal indicated in patients 18 years of age or older who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval of this indication is based on limited clinical safety and efficacy data. Product Specifications: HCPCS Code J0349 HCPCS Code Descriptor Injection, rezafungin, 1 mg 11-Digit NDC 70842-0240-01 Package Description 200 mg as a solid (cake or powder) in a single-dose vial for reconstitution WAC Pricing $9.75 per HCPCS Unit Potential Diagnosis Codes: ICD-10-CM Description B37.1 Pulmonary candidiasis B37.7 Candidal sepsis B37.81 Candidal esophagitis B37.82 Candidal enteritis B37.89 Other…

09/15/2023

New Indication for Bardet-Biedl syndrome (BBS) - 9/15/23

New Indication for Bardet-Biedl syndrome (BBS) Effective October 1, 2023 On September 5, Rhythm issued a press release announcing the new ICD-10-CM code specific to Bardet-Biedl syndrome (BBS) ‒ Q87.83 ‒ effective October 1, 2023. Read Rhythm Press Release This new ICD-10-CM code specific to BBS has the potential to improve patient identification and ongoing monitoring, which may help providers and payers: Accurately…

09/13/2023

Safely Treating Molluscum Using YCANTH (FDA) - 9/13/23

FDA Consumer Update Safely Treating Molluscum Using YCANTH™ Recommendation Issued by the FDA The FDA has issued two consumer updates since June 2023, focusing on the management of Molluscum Contagiosum. The first FDA alert was issued in June 2023, and an updated alert was published following the approval of YCANTH in August. Below is the full text of the consumer update published by the FDA on August 23, 2023: View Full FDA Article FDA Article Highlights "Safely Treating Molluscum, a Common Skin Condition" If you’re bothered by bumps on your skin, don’t try to diagnose yourself or treat your condition with products that haven’t been approved by the U.S. Food and Drug Administration. Instead, visit a health care professional for a proper diagnosis and to make a treatment plan. One common condition that some people try to self-diagnose and treat is molluscum contagiosum, a skin infection caused by a virus. But by doing so, you run the risk of delaying the diagnosis and treatment of a…

FDA Approved 09/13/2023

Now Approved: APHEXDA™ (motixafortide) for injection - 9/12/2023

NOW APROVED: APHEXDA TM (motixafortide) for injection APHEXDA™ is indicated in combination with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma. APHEXDA TM (motixafortide) for injection, for subcutaneous use U.S. Approval: 2023 NDC Dosing Form and Strength WAC Pricing 82737-0073-01 For Injection: 62 mg as a lyophilized powder in a single-dose vial for reconstitution $5900 per vial IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS APHEXDA is contraindicated in patients with a history of serious hypersensitivity reactions to motixafortide. WARNINGS AND PRECAUTIONS Anaphylactic Shock and Hypersensitivity Reactions : Anaphylactic shock and hypersensitivity reactions have occurred. Premedicate all patients with a triple drug premedication regimen that includes an H1 -antihistamine, an H2 blocker, and a leukotriene inhibitor approximately 30-60 minutes prior to each dose…

09/07/2023

Announcing the approval of EYLEA® HD (aflibercept) Injection 8 MG (8/18/23) - 9/7/23

Effective August 18, 2023 Effective August 18th, 2023 EYLEA ® HD (aflibercept) Injection 8 MG has been approved as a new single source drug by the FDA Suggested Billing and Coding for EYLEA HD** HCPCS CODES EYLEA HD NDC* PACKAGE DESCRIPTION WAC Per Package J3490: Unclassified drugs J3950: Unclassified Biologicals 61755- 0 050-01 xxxxxxxxxxxxxxxxxxxxx Vial kit containing one EYLEA HD 8 mg (0.07 mL of a 114.3 mg/mL solution) single-dose glass vial, one 18-gauge x 1½-inch, 5-micron, filter needle for withdrawal of the vial contents, one 30-guage x ½-inch injection needle for intravitreal injection and one 1-mL syringe for administration, one Prescribing Information $2625.00 *Note that the product’s NDC has been “zero-filled” to ensure creation of an 11-digit code that meets general billing standards. The zero-fill location is indicated in bold. **This information is provided for informational purposes only, is subject to change, and should not be construed as legal or medical advice.…

J-Code 09/07/2023

Permanent J-Code for SYFOVRE® Effective October 1, 2023 - 8/31/23

Email content sponsored by Apellis Pharmaceuticals, Inc. Email content sponsored by Apellis Pharmaceuticals, Inc. Effective for claims on and after October 1, 2023: J2781 SYFOVRE (pegcetacoplan injection) is indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) SELECT SAFETY INFORMATION SYFOVRE is contraindicated in patients with ocular or periocular infections, and in patients with active intraocular inflammation. Please see additional Important Safety Information below. PRODUCT SPECIFICATIONS 1 : Permanent J-Code J2781 , effective October 1, 2023 CMS Long Descriptor 2 Injection, pegcetacoplan, intravitreal, 1 mg* * Dose descriptor is assigned by CMS; please see full prescribing information for approved dosing NDC Number 10-digit: 73606-020-01 and 11-digit: 73606-0020-01 CPT Code 3 67028: Intravitreal injection of a pharmacologic agent, separate procedure Geographic Atrophy ICD-10-CM Diagnosis Codes 4 Non-exudative age-related…

FDA Approved 07/31/2023

Now Approved: AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) - 7/31/23

Funded and Developed by GSK: NOW APPROVED: Coding and Pricing: CPT Code Presentation Carton NDC Number WAC Pricing 90679 Outer Carton of ten doses 58160-0848-11 $280/dose* Please take a moment to update any of your reimbursement, billing, and ordering systems to reflect this change. *Wholesale acquisition cost (or WAC), also known as list price, is the price to wholesalers and warehousing chains, not including prompt pay, stocking or distribution allowances, or other discounts, rebates, or chargebacks. WAC may not represent prices charged to other customers, including specialty distributors, and is not the price that most patients pay for the product. For more information on the prices patients pay, please check with the patient's healthcare provider. WAC price as of 07/23. Indication AREXVY is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in individuals 60 years of age and older. Important Safety…

1 … 121314 … 17

No alerts match your filters.