The pilot of implementing a diagnosis-related group (DRG) payment model to inpatient hospital care, a major initiative of China’s ongoing healthcare reform, started in 2019. Boston Healthcare Associates has been vigilant in tracking this strategic topic given the implications on the industry and the healthcare ecosystem as a whole.
Eight leaders in Life Sciences came together for a virtual breakfast roundtable devoted to leading Life Sciences organizations through these unprecedented times.
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.
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.
Press Releases and Publications
Thomas Goss Participates in 3rd Annual Leaders in Life Sciences Breakfast Roundtable
10 September 2020
On September 10, 2020, a strategic partnership of Boston Healthcare Associates; Buchanan Ingersoll & Rooney PC; and LevLane hosted the 3rd Annual Leaders in Life Sciences Breakfast Roundtable.
During the event, industry leaders shared their insights on the impact of COVID-19 on raising capital, working with investors, and facing drug pricing and reimbursement challenges — as well as other current issues that are currently impacting the healthcare industry.
Use the link below and sign up to receive the 2020 Leaders in Life Sciences Playbook containing those insights and learnings from the event.
Download the playbook here: https://bit.ly/3mVr3v9
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.
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.
Boston Healthcare Adds Seasoned Market Access Leader to Global Life Science Consulting Team.
Cost-Conscious MedSeq Project Provides Snapshot to Suggest Genomic Sequencing does not Increase Downstream Healthcare Costs
CEO, Joseph V. Ferrara commented on the value sequencing might bring to the clinical setting in the May-June 2018 Issue of Clinical Omics. Access the article here.
Global Business Reports
United States Biopharmaceuticals 2018
Thomas F. Goss spoke to Global Business Reports on the US Biopharmaceutical Industry. Read the report here.
Real-World Evidence in the Era of Advanced Diagnostics
Shivang Doshi, Director at Boston Healthcare wrote an op-ed for the March-April edition of Clinical Omics on real-world evidence for advanced diagnostics. Access the article here.
International Regulatory Group Proposes Principles for Evaluating Safety, Performance of Diagnostics
Joseph V. Ferrara, CEO of Boston Healthcare spoke with 360Dx News about the proposed Principles for safety and performance of medical devices, including IVD medical devices, put forward by the International Medical Device Regulators Forum (IMDRF). Read the article here.