C&M Health Law

C&M Health Law

Analysis, commentary, and the latest developments in health care law and policy

Maya Uppaluru

Subscribe to all posts by Maya Uppaluru

New CMS Incentives for Remote Patient Monitoring and Patient Access

Posted in Digital Health
CMS has issued its 2019 Physician Fee Schedule Proposed Rule, containing highly anticipated new reimbursement policies for telehealth, remote monitoring, and other uses of digital tools, as well as updates to health IT requirements in the Quality Payment Program, with a stronger focus on patient access to health information. Comments are due September 10 at… Continue Reading

FDA’s Medical Device Safety Action Plan

Posted in Digital Health, FDA, Health IT
On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to address medical device safety while preserving enough space for innovation in the market. The FDA’s plan is the latest effort by the FDA on medical device safety, including a recent budget request… Continue Reading

FDA Advances Flexibility-Based Framework for Digital Health and AI

Posted in FDA, Health IT, Medicaid, Medicare
The Food and Drug Administration (FDA) has announced several new initiatives that reflect its ongoing commitment to maintain patient safety, while also championing the need and opportunity for health care innovation. During opening day of Health Datapalooza, FDA Commissioner Scott Gottlieb highlighted the critical import of novel digital health tools in achieving patient-centered care, and… Continue Reading

CMS Signals Future Patient Access Requirements for Medicare Advantage Plans

Posted in Health IT, Medicare
Building on momentum from Administrator Seema Verma’s announcement of the MyHealtheData initiative at HIMSS 2018, CMS has published more clues as to future action to liberate health information for patients. In the CY 2019 call letter to Medicare Advantage organizations and Part D programs, CMS describes the Blue Button 2.0 project and its use of… Continue Reading

FDA Issues New Guidance for Clinical and Patient Decision Support Software

Posted in Digital Health, EHR, Health IT
This morning, the Food and Drug Administration released highly anticipated guidance on clinical and patient decision support that has been in the works at the agency for several years, advising the digital health community about how it plans to regulate software that offers recommendations or feedback to its users—both healthcare professionals, and patients and caregivers.… Continue Reading

New Reimbursement for Remote Patient Monitoring and Telemedicine

Posted in EHR, Health IT, Medicare
CMS announced important changes to Medicare reimbursement for remote patient monitoring and telemedicine that can help accelerate adoption and use of these digital health tools. These changes are implemented through two rules released this week that will take effect January 1, 2018. Understanding these rules can help you incorporate these tools into clinical practice and… Continue Reading

Interoperability by Design: FDA Issues New Final Guidance for Connected Medical Devices

Posted in FDA, Health IT
The FDA is focusing on safety and effectiveness of interconnected medical devices with the issuance of final guidance on medical device interoperability, released last week. As the FDA notes, medical devices are becoming increasingly connected to one another and to other technologies, and it is critical to address their ability to exchange and use information… Continue Reading