The director of Health Economics and Reimbursement for the Regulatory & Clinical Research Institute (RCRI) discusses the repercussions of implementing ICD-10.
In a comment to Applied Clinical Trials, Monica M. Schultz, M.S., Director of Health Economics and Reimbursement for Minneapolis-based Regulatory & Clinical Research Institute (RCRI), said, "ICD-10 will have an enormous impact to hospitals and their billing structure. It's a huge change that hospitals and insurers have been anticipating for several years, but not necessarily preparing for, because the timing of the change was uncertain. The new coding system appears more logical, but expect a painful transition.”
Schultz anticipates that ICD-10 will impact clinical trials via billing for Category B devices. However, she believes difficulties may be minimized via proper training. Here are her tips: “At the initiation visit, schedule time with the billing manager to provide a list of procedures included in the protocol and associated billing codes. Sponsors may also consider providing a toll-free "hotline" to answer questions from the site. All reimbursement reference materials should be reviewed by the sponsor's legal department, as it should be made clear it is the site's responsibility to verify appropriate codes with the insurer.”
Visit RCRI's Web site at http://www.rcri-inc.com/ Schultz co-authored an article regarding “Medicare’s Proposed Cost-Effectiveness Criteria Revisited: Considerations for Clinical Trials Design,” scheduled to appear in the May issue and the Web site of Applied Clinical Trials.
FDA Fast Tracks Johnson & Johnson’s Nipocalimab for Fetal Neonatal Alloimmune Thrombocytopenia
March 27th 2024Johnson & Johnson is moving forward with a pair of Phase III trials of nipocalimab to reduce the risk of fetal neonatal alloimmune thrombocytopenia in alloimmunized pregnant patients.
Citius Pharmaceuticals Resubmits BLA to FDA for Lymphir to Treat Cutaneous T-Cell Lymphoma
March 19th 2024Pivotal Phase III Study 302 trial data show an objective response rate of 36.2% based on an independent review committee assessment in the treatment of relapsed/refractory cutaneous T-cell lymphoma.