Endocrinology reimbursement alerts

Mounjaro (tirzepatide) is administered via subcutaneous injection, which typically places self-administered drugs under Medicare Part D rather than Part B — the 'Part B' billing pathway noted here war

Zepbound (tirzepatide) is a subcutaneous injection approved for a new indication under NDA217806, distinct from Mounjaro (also tirzepatide). Despite the listed billing pathway of Part B, subcutaneous

Synjardy (empagliflozin/metformin HCl) is an oral tablet combination approved for type 2 diabetes management, billing under Medicare Part D through prescription drug plans. As an oral medication with

Kazano (alogliptin/metformin HCl) is an oral tablet combination approved for type 2 diabetes management, billing under Medicare Part D as a self-administered drug. As an oral combination product with

Segluromet (ertugliflozin and metformin hydrochloride) is an oral tablet combination approved for type 2 diabetes management, billing under Medicare Part D as a self-administered drug. No J-code appli

Jentadueto XR is an oral extended-release tablet combining linagliptin (a DPP-4 inhibitor) and metformin hydrochloride, approved for type 2 diabetes management. As an oral combination product, it foll

Janumet XR (sitagliptin/metformin HCl extended release) is an oral tablet approved as a new dosage form for type 2 diabetes management, billing under Medicare Part D through commercial pharmacy channe

Fortamet (metformin hydrochloride extended-release) is an oral tablet approved under a Type 5 new formulation submission, placing it squarely in the Medicare Part D billing pathway. As a brand-name ex

Dapagliflozin and Metformin Hydrochloride (NDA205649), approved by Prasco Laboratories as an oral extended-release tablet combination, follows a Part D billing pathway as a retail oral medication. Thi

Synjardy XR (empagliflozin/metformin HCl extended-release) is an oral tablet approved as a new dosage form of an existing SGLT2 inhibitor/biguanide combination, billing under Medicare Part D. As an or

Actoplus Met (pioglitazone/metformin HCl) is an oral tablet combination approved for type 2 diabetes management, billing under Medicare Part D as a retail pharmacy benefit. As an oral drug, it does no

Invokamet (canagliflozin/metformin HCl) is an oral tablet combination approved for type 2 diabetes management, billing under Medicare Part D as a self-administered drug. As an oral combination product

Invokamet XR (canagliflozin and metformin hydrochloride extended release) is an oral tablet approved as a new combination product for type 2 diabetes management, billing under Medicare Part D as a sel

Kombiglyze XR (metformin hydrochloride/saxagliptin) is an oral extended-release combination tablet approved for type 2 diabetes management, billing under Medicare Part D as a self-administered oral me

Zituvimet XR is an oral extended-release tablet combining sitagliptin and metformin hydrochloride, approved as a new formulation under NDA216778, and billed through Medicare Part D. As a Type 5 approv

Zituvimet is an oral metformin hydrochloride tablet approved under NDA216743 as a new formulation/manufacturer entry (Type 5), indicating it is a reformulated or repositioned version of an established

This approval represents a Type 5 (new manufacturer) extended-release oral tablet formulation of metformin hydrochloride, a long-established generic diabetes medication, by Oceanside Pharmaceuticals.

TRIJARDY XR is an oral extended-release tablet combining empagliflozin, linagliptin, and metformin hydrochloride for type 2 diabetes management, approved as a new combination product. As an oral medic

Jentadueto (linagliptin/metformin HCl) is an oral tablet combination approved for type 2 diabetes management, billing under Medicare Part D through prescription drug plans. As an oral, non-injectable

Riomet ER (metformin hydrochloride) is an oral extended-release suspension formulation of a well-established generic drug approved under NDA212595, billing through Medicare Part D as a retail pharmacy

Janumet (sitagliptin/metformin HCl) is an oral tablet combination approved for type 2 diabetes management, billing under Medicare Part D as a self-administered drug. As an oral medication dispensed at

This approval is a Type 5 (new formulation/manufacturer) subcutaneous teriparatide solution from Alvogen, a generic/biosimilar-type entry for the parathyroid hormone analog already established in the

Prasco Laboratories received approval for a subcutaneous solution formulation of teriparatide (NDA021318), a parathyroid hormone analog used primarily for osteoporosis. Because the route of administra

Almaject's teriparatide (NDA218771) is a subcutaneous solution approved as a new formulation/manufacturer entry, meaning it is a follow-on to the established teriparatide market (e.g., Forteo). Given

Tymlos (abaloparatide) is a subcutaneous parathyroid hormone-related peptide analog approved for osteoporosis, typically self-administered by patients at home. Despite its subcutaneous route, home sel

Yorvipath (palopegteriparatide), approved August 2024 as a new molecular entity for a rare endocrine condition, is administered subcutaneously and billed under Medicare Part B. As a newly approved orp

Foundayo (orforglipron) is an oral tablet approved under NDA220934, placing it squarely in the Medicare Part D billing pathway rather than Part B. As an oral GLP-1 receptor agonist tablet, it will be

Macrilen (macimorelin acetate) is an oral growth hormone secretagogue receptor agonist approved for diagnosing adult growth hormone deficiency (AGHD), designated as an orphan drug. As an oral formulat

Pheburane (sodium phenylbutyrate) oral pellets, approved under NDA216513 as a new formulation by Medunik, is an orphan drug indicated for urea cycle disorders administered orally. As an oral formulati

This final LCD from Wellpoint Federal establishes coverage criteria for molecular testing of thyroid nodules, effective April 1, 2026. It governs when molecular diagnostic tests (such as gene expressi

This FDA approval covers a vaginal insert dosage form of progesterone (NDA022057), manufactured by Sun Pharmaceutical Industries, approved in 2007 as a new dosage form. As a vaginally administered ins

Fresenius Kabi's intravenous levothyroxine sodium (NDA202231) is administered via the intravenous route, supporting a Medicare Part B billing pathway for hospital and clinical settings. As an IV formu

Phentermine and topiramate extended-release capsules (NDA022580, Prasco Laboratories) are an oral combination product approved for weight management, following the billing pathway of Part D coverage t

The extension of in-person delivery flexibility for the MDPP until December 31, 2023, allows suppliers to adapt their services during ongoing transitions from the Public Health Emergency. This policy

The new LCD for HbA1c testing could significantly alter billing practices for diabetes management, especially with Palmetto GBA as the contractor. Providers may need to adjust their coding and documen

The implementation of the new LCD for Implantable Continuous Glucose Monitors (I-CGM) by WPS may affect billing processes for diabetes management services. Providers will need to familiarize themselve

The implementation of GlycoMark® testing for glycemic control represents a significant change in billing practices, particularly for outpatient services. This may lead to supports compliance with updated rates oppor

The addition of salivary hormone measurement to Medicare coverage may lead to increased compliance updates for providers. This could enhance patient management strategies by providing more comprehe

The new LCD addresses the billing for low testosterone treatment in males, potentially increasing reimbursement opportunities for providers offering this service. It is essential for practitioners to

The introduction of the LCD for Implantable Continuous Glucose Monitors (I-CGM) by Noridian is expected to supports compliance with updated rates practices for diabetes management. Providers will need to familiarize themsel

The LCD on the treatment of males with low testosterone affects billing practices by establishing specific criteria for coverage. Providers must ensure compliance with these criteria to avoid claim de

The introduction of GlycoMark® testing for glycemic control by Noridian significantly impacts billing processes, as it may alter coverage eligibility and documentation requirements for both providers

The LCD for Measurement of Salivary Hormones indicates covered services and sets standards for compliance, impacting billing practices for related tests. Providers will need to ensure proper documenta

The upcoming LCD for Implantable Continuous Glucose Monitors (I-CGM) will redefine billing practices for testing and monitoring diabetic patients. Providers need to adjust their billing processes to a

The implementation of coverage for Implantable Continuous Glucose Monitors (I-CGM) starting October 16, 2025, is expected to significantly enhance patient management for those with diabetes. Consequen

The introduction of the MolDX LCD for molecular testing of thyroid nodules may lead to increased compliance updates for physicians who can now utilize these advanced tests for risk stratification.

The new LCD from Noridian on molecular testing for thyroid nodules is expected to significantly impact billing practices surrounding risk stratification. Providers will need to familiarize themselves

The implementation of coverage for Implantable Continuous Glucose Monitors (I-CGM) starting February 9, 2026, will significantly impact billing practices by providing new opportunities for reimburseme

The inclusion of GlycoMark® Testing for glycemic control may enhance patient management for diabetes, potentially leading to better outcomes and appropriate reimbursement. This could also impact billi

This LCD covers the use of molecular testing for risk stratification of thyroid nodules, impacting the billing for these specific tests. Healthcare providers should ensure correct documentation and co