Hospitals and medical device manufacturers will both benefit from the Centers for Medicare and Medicaid Services’ (CMS) finalization of the 2020 Inpatient Prospective Payment System (IPPS) Final Rule (“Final Rule”) scheduled to be published on August 16, 2019. In an effort to increase Medicare beneficiaries’ access to innovative medical technologies, CMS has finalized certain changes to the “new technology add-on payment” “(NTAP) application and payment processes under the Final Rule. This change is likely to encourage hospital adoption of new technologies, which is intended to spur innovation and additional investment in these technologies.
Nixon Law Group's managing partner, Carrie Nixon, is featured on this month's Health IT Trends Buzz podcast by the North Carolina Healthcare Information and Communications Alliance (NCHICA). Click here to listen!
Ostendio, a leading provider of cybersecurity and risk management solutions, today announced that they have partnered with Nixon Law Group, a boutique healthcare law firm headquartered in Virginia, to make it easier for organizations to comply with the ever-changing healthcare privacy regulatory requirements. This partnership brings together a leading-edge software platform with top-tier healthcare attorneys to help organizations better navigate the highly regulated healthcare industry.
The U.S. Food and Drug Administration is currently accepting requests from medical software developers to participate in a precertification pilot program that is scheduled to begin September 1, 2017. The program is aimed at developing precertification criteria for software companies that would allow approved companies to engage in a streamlined premarket review process for certain digital health products. The FDA will accept up to nine participants for the pilot program, which the Agency says will include both large, established software developers and small startup companies.
On May 31, 2017, the U.S. Department of Justice announced that electronic health records (EHR) vendor eClinicalWorks (ECW), along with certain individual officers and employees, have agreed to pay a total of $155 million to settle a lawsuit under the False Claims Act (FCA). In its Complaint-in- Intervention, the government alleged ECW falsified compliance with certification requirements for EHR under the Meaningful Use program. The programming shortcuts ECW allegedly took in developing its software, along with inadequate post-market support and patches, could expose providers to increased risk of errors and jeopardize patient care. If you or your practice uses the eClinicalWorks software, you should be aware of ECW’s obligations and your rights under the Corporate Integrity Agreement (CIA).
Health IT vendors are under incredible pressure to represent to customers that their hardware and software solutions are impervious to cyber threats. Pick any major trade show and the first line you'll hear from exhibitors is that their solution is HIPAA-compatible, and, even more misleading, HIPAA-compliant. It's important that vendors understand overstating security protocols and capabilities can have major legal and financial implications.