A March 24 article, “Health Tech Oversight Up in the Air in Wake of New HHS Position,” in Bloomberg BNA’s Health IT Law & Industry Report and other publications reported that federal oversight of health information technology policy could be in limbo with the creation of a new Department of Health and Human Services position focused on health technology. The position is expected to be filled by former Rep. John Fleming (R-La.). Day Pitney healthcare attorney Eric Fader was quoted in the article.
Three health-related mobile application developers, Cardiio, Runtastic and Matis, are required to pay a combined $30,000 in penalties, change misleading ads, and post prominent disclaimers that the apps are not medical devices and are not approved by the Food and Drug Administration under a settlement announced by the New York Attorney General’s Office on March 23.
The Centers for Medicare & Medicaid Services (CMS) has announced a delay in the effective date of planned cardiac care bundled payment initiatives and the expansion of the Comprehensive Care for Joint Replacement Model through an interim final rule published
in the Federal Registrar on March 21. The bundled payment models which had been set to take effect this July have been pushed back to October 1, 2017, and CMS is seeking comments regarding a possible additional delay in the expansion until 2018.
A March 21 article
in Bloomberg BNA’s Life Sciences Law & Industry Report
and other publications discussed the possibility that the existing safe harbors under the federal Anti-Kickback Statute may be modified or expanded to take into account alternative healthcare payment models. Eric Fader was quoted in the article.
Horizon Healthcare Services Inc., a health insurance company doing business as Horizon Blue Cross Blue Shield of New Jersey that insures more than 3.7 million New Jersey residents, recently entered into a consent judgment
under which it agreed to pay a $1.1 million settlement to the state to resolve a data breach that affected 690,000 policyholders.
On March 15, Eric Fader presented a live webinar for The American Society of Neurophysiological Monitoring (ASNM) entitled "Navigating Legal Issues in Neuromonitoring." The webinar was recorded and will be available on demand from the ASNM website
within a few days. It is free for ASNM members and costs $59 for non-members, and is approved for one hour of ASNM-CEUs and AMA PRA Category 1 Credit.
The Centers for Medicare & Medicaid Services (CMS) announced
that it has extended the March 13 submission deadline for 2016 Quality Reporting Document Architecture (QRDA) data submission for the electronic health record (EHR) reporting mechanism of the Physician Quality Reporting System (PQRS) program.
A new mandate under the Federal Notice of Observation Treatment and Implication for Care Eligibility Act (NOTICE Act), passed on August 6, 2015, went into effect on March 8. Hospitals across the country are now required to inform Medicare patients: (i) that they are getting observation care, (ii) why they were not admitted, even if they stay in the hospital a few nights, (iii) that they may have additional financial responsibilities, and (iv) if they are transferred to a nursing home Medicare won’t pay, because they haven’t met the requirement of being an inpatient for three days. For years, seniors often received this information only when they received surprise bills for the services Medicare doesn’t cover for observation patients, including some drugs and expensive nursing home care.
A March 2 article
in Bloomberg BNA’s Privacy Law Watch
and other publications, “Privacy and Security Audits May Be Moving From Education to Enforcement,” reported that the Department of Health and Human Services’ Office for Civil Rights’ (OCR’s) ongoing HIPAA privacy and security audits may be shifting focus from provider education to enforcement. All healthcare providers and business associates, not only OCR audit subjects, must ensure that their compliance and operational teams are working together to detect vulnerabilities. Day Pitney’s Eric Fader was quoted in the article.
The following is reprinted verbatim from a March 3 email message from the Department of Health and Human Services: