CMS Continues to Modernize by Expanding Reimbursement for Digital Health Services

The COVID-19 Public Health Emergency (“PHE”) fundamentally changed the healthcare industry, forcing healthcare providers and patients onto their computers and phones to enable continuation of care when patients were mandated to stay home across the country. Prior to the COVID-19 PHE, approximately 12,5000 Medicare beneficiaries received telehealth services and only 106 telehealth services were reimbursable. By October 2020, over 24.5 million (of 63 million) Medicare beneficiaries received telehealth services.

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A Primer on Patenting Ranges

Clinical drug candidates are often claimed in a patent as a pharmaceutical composition or formulation with a specified concentration range of the drug or an excipient; as being purified within certain temperature or pH ranges; or in a method of treating a disease by administering the drug at a certain dosage range. For a claim to be patentable over any prior disclosure, the claim must be novel and nonobvious. But how would a drug developer know that the claimed ranges are patentable over a prior disclosure of overlapping or broader ranges?

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For Clinical Trial Recruiting, Words Matter

In a recent publication we helped co-author, we examined ClinicalTrials.gov entries and their possible impact on informing potential subjects of their eligibility to participate in clinical trials. In particular, we analyzed certain clinical trials focused on HIV treatment or prevention that allowed entry of pregnant women to assess the use of pregnancy-related terms in each trial’s description and inclusion/exclusion criteria, such as those relating to gestational age and trimester. The assessment focused on evaluating the potential utility of ClinicalTrials.gov for pregnant women and their healthcare providers in identifying potential clinical research in which they may be eligible to participate.  In brief, we found that descriptors and terminology can play an important role in communicating with providers and prospective subjects about eligibility for participation. While our findings are in the context of HIV research and pregnant women, our takeaways could apply to other disease areas and populations where specific terminology may play a role in successful identification and recruitment of eligible patients, particularly where competition for patients presents an ongoing challenge, such as rare diseases.

Read the full article in Contemporary Clinical Trials Communications.