In order to move health care organizations towards consistency in mitigating important cybersecurity threats to the health care sector, the Department of Health & Human Services (HHS) published multiple guidance documents on best practices for health care organizations to reduce cybersecurity risks (“HHS Cyber Guidance”). The HHS Cyber Guidance is the result of HHS’ public-private partnership with more than 150 cybersecurity and health care experts. While compliance is voluntary, this guidance serves as direction to…

  More of our health information is becoming digital every day, as new technology companies enter the health care and wellness markets. Many companies that hold a wealth of consumer health information are not covered by HIPAA. Many consumers may not realize that their health information only is protected and they only have certain rights with respect to that information when it is held by certain entities, but not when it is held by others.…

CMS has finalized the adoption of multiple CPT codes in the CY 2019 PFS that create more opportunities for providers and digital health companies to collaborate on chronic care management business models in the fee-for-service market. Virtual Check-Ins CMS finalized the creation of a new code to reimburse providers for brief “check-in” services conducted using communications technology by creating HCPCS code G2012, defined as “[b]rief communication technology-based service, e.g. virtual check-in.”…

Yesterday, the FDA released draft guidance on the management of cybersecurity in medical devices submitted to the agency for premarket review. Noting that cybersecurity threats to the healthcare sector have increased in number and severity, the FDA offered new recommendations for device design, labeling, and documentation that medical device manufacturers will need to consider during premarket submission processes. The guidance comes shortly after the FDA’s launch of its Medical Device Cybersecurity Playbook, which provides…

On October 15, 2018, the Centers for Medicare & Medicare Services (“CMS”) in the Department for Health and Human Services proposed a rule to require prescription drug manufacturers to post the Wholesale Acquisition Cost (“WAC”) for drugs and biological products covered by Medicare or Medicaid in direct-to-consumer television advertisements. The WAC reflects the manufacturer’s list price for a drug to direct purchasers, not inclusive of any discounts or rebates. CMS is proposing this rule in…

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 5pm.…

This blog post has been prepared in collaboration with Validic. Mr. Schiller is CEO of Validic. Jodi Daniel is a partner in Crowell & Moring’s Health Care Group in Washington, D.C. Our healthcare system is in the midst of a fundamental shift toward value-based care to drive down costs and improve the quality of care. We won’t be able to achieve that goal without technology that allows providers to collect and use health data…