CMS Proposes Changes to Part B Medicare Reimbursement for Physician-Administered Drugs Approved Under the 505(b)(2) Approval Pathway
The Centers for Medicare and Medicaid Services (CMS) intends to alter assignment of Healthcare Common Procedure Coding System (HCPCS) Level II codes for certain physician-administered 505(b)(2) drugs.
Medicare Clarifies Confusion Over Tests Covered by the NGS NCD
Recently, Medicare published two CRs associated with the NGS NCD, identifying covered tests and associated CPT and ICD-10 diagnosis codes. These CRs (CR11655 and CR11749) indicated that MSK-IMPACT and MyMRD NGS Panel were nationally covered under the NGS NCD.
G-BA Specifies Procedures for Coverage with Evidence Development- Gene Therapy Zolgensma® First Case
In Germany, the Federal Joint Committee (G-BA) recently amended its rules of assessment procedures to consider new therapies and products without complete clinical data at the time of approval.
China Establishes a Regulatory Pathway for Companion Diagnostics
The National Health Commission of China recently released a clinical practice to regulate physician prescribing behavior for novel cancer therapies which echoes the government's efforts to control costs.
CMS New Technology Add-On Payment FY 2021 Proposed Rule
The Centers for Medicare and Medicaid Services’ NTAP program is a system enacted by Congress and implemented in 2001 designed to enable the adoption of new and clinically beneficial medical technologies used during inpatient hospital stays regularly paid under Medicare’s inpatient prospective payment system.
ICER Quietly Moves to a Pure Digital Health Assessment
ICER has quietly moved forward with their first foray into a pure digital health assessment: their revised scoping document for analysis of digital apps in opioid use disorder was recently released.
Webinars and Digital Events
Publications
BHA Presents Study Results at the National Kidney Foundation Spring Clinical Meeting
April 2021
Dr. Datar and colleagues used conjoint analysis to estimate preferences regarding kidney disease testing from 401 PCPs via a web survey. Hypothetical patient profiles created using clinical parameters demonstrated the clinical utility of a novel kidney diagnostic used to risk-stratify patients based on the risk of kidney function decline. Read the article here.
BHA Partners with Alcon to Conduct Real-World Study Highlighting Efficiencies of Optical Biometer in Cataract Surgery
December 2020
Alcon, a global leader in eye care, collaborated with Boston Healthcare to conduct a Time-and-Motion Study to support the value communication of its novel swept-source optical coherence tomography biometer, ARGOS®. The ISPOR abstract, titled, Time Efficiencies Associated with an Innovative Optical Biometer in Cataract Surgery Planning- A Time-and-Motion Study, can be found here, and will be published in the upcoming Value in Health Journal (December 2020 Issue, Volume 23 and Issue S2).
Boston Healthcare Presents Key Findings Associated With the Use of an AI-Enabled In Vitro Diagnostic Test
27 March 2020
The Boston Healthcare team presented key findings related to the health economic value associated with the use of an AI-enabled in vitro diagnostic test to identify CKD patients with type 2 diabetes at risk for rapid kidney function decline. BHA’s Senior Vice President, Thomas Goss, made a presentation during the late-breaker session at the National Kidney Foundation Spring Clinical Meeting in March 2020.
Read the article here: https://bit.ly/2UKaJks
View the poster here: https://bit.ly/2UFIx27
Diagnostics Developers Rapidly Utilizing New Payment Codes Established by PAMA
7 November 2018
Access the article from 360Dx here.
Clinical Omics
Compliance Conundrum: Genomic Health Faces DoJ Investigation after CMS Changes Date of Service Regs
Genomic Health has disclosed that it is the subject of a U.S. Department of Justice investigation into its compliance with changes that took effect in January to Medicare’s Date of Service billing regulation. Adam Crowther, Manager, spoke with Clinical Omics about the impact on diagnostics companies. Access the Article Here.
Medical Device & Diagnostics Industry
Considering Market Access Risk as Part of Today’s M&A Process
In an exclusive published today in Medical Device and Diagnostics Industry, Vice President, Rob Wenthold discusses the key market access issues examined during the M&A process and demonstrates the importance of market access to inform M&A through case studies and business decision-making in general. Read the article here.