There is no lack of codes. Current procedural terminology (CPT) codes are used primarily to identify medical and surgical procedures and services performed by physicians and other health care professionals. Codes for diagnosis related groups (DRGs) are a classification system developed by Medicare as part of the prospective payment system for inpatient care. There are
The two “Rs” — regulatory and reimbursement — are critical elements of the environment in which a medical device product is developed. The design of innovative products in the highly regulated medical environment actually influence all stages of medical device development from the earliest stages of the development effort to its conclusion. Let’s first consider
Angels, venture capitalists and strategic partners don’t want to commit financial resources to help a manufacturer develop a new medical device if they feel they will not get adequate return on investment in a reasonable timeframe. That makes perfectly good sense. Such a manufacturer must first perform a preliminary analysis as to whether their medical
Applying for a New CPT Code For almost all medical devices associated with a medical or surgical procedure, there must be a corresponding CPT code. It’s simple – if there is no CPT code for those who perform the procedure to place on a billing claim to receive payment from insurers, providers will not use
How do manufacturers of a new medical devices determine what is the best price for their product? The typical method is to look for similar products in the marketplace and arrive at a price which will be competitive. However, there are certain circumstances that will allow you to set a higher price based on what
In our experience, the most common mistake medical device manufacturers make is to conduct clinical trials they design themselves without a reimbursement consultant’s input. A study which results in adequate scientific evidence to prove that your medical device is effective in improving the clinical outcomes of patients is crucial for you to obtain coverage from
In recent years, reimbursement by insurers has trumped FDA regulatory approval as the medical device industry’s biggest concern and remains at the forefront of stakeholders’ minds. To prevent reimbursement issues from impacting financing goals, device manufacturers must develop a well-planned reimbursement strategy in parallel with their regulatory and clinical strategies in the early phases of
These days, it often seems the main struggle for medical device companies is not earning FDA regulatory approval, but rather, securing reimbursement and payment from CMS and private payers. Here are some tips for you to consider. First, develop a reimbursement strategy early on in your product’s development by receiving recommendations from a consulting reimbursement
The FDA’s regulations state that isolated case reports, random experience, reports lacking enough detail to permit scientific evaluation, and unsubstantiated opinions do not constitute valid scientific evidence. More device manufacturers are recognizing the importance of considering Medicare coverage and reimbursement principles during the development of their new technologies. By adopting long- and short-term strategies that
Good clinical studies are the most important piece of data to have to present in a dossier (portfolio) to the payer. These studies are published as full-text in peer-reviewed journals, with study subjects that represent the beneficiaries covered by the payer, outcomes that show improvements in health benefits of their members and representing a large
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