On Friday, September 30, 2016 the Centers for Medicare &
Medicaid Services (CMS) sent the 2017 Hospital Outpatient PPS and
Ambulatory Surgical Center final rule to the Office of Management
and Budget (OMB) for review. OMB review typically is the last step
in the review process before a rule is released. While the OMB can
take up to 90 days to review the rule, and can extend that 90 days
if needed, the OPPS/ASC final rule must be posted by November 1st
by statute, and CMS typically meets that deadline.
McDermottPlus’s multi-disciplinary team of clinicians,
data analysts and regulatory and legislative experts are developing
resources to help medical professional societies, health service
providers and product companies understand and analyze the impact
of the OPSS/ASC and other Medicare payment regulations anticipated
this fall such as MACRA, the Medicare Physician Fee Schedule and
the Part B Drug Payment Model.
Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k "substantially equivalence" medical device clearance as non-preemptive because it was supposedly "focused on equivalence, not safety"? Id. at 493.
The US Food and Drug Administration (FDA) related portions of the 21st Century Cares Act, found in title III, establish a streamlined process for the exemption of certain Class I and II devices from the premarket notification requirement and allow for the establishment of revised regulatory standards for accessories to high-risk devices.
Hospitals are commonly named as defendants in medical malpractice lawsuits for claims arising from alleged injuries within their walls, but what is their exposure to liability for claims that arise from alleged sexual assaults by staff on their premises?
Eric Fader was quoted in a November 9 article, "Incoming Trump Administration May Mean Less Funding for HIPAA Audits," in Bloomberg BNA's Health Care Fraud Report. Eric said that the incoming Trump administration may eventually be forced to reduce funding for some healthcare initiatives to pay for other priorities, such as large tax cuts and increased spending on the military.
Title III of the 21st Century Cures Act includes portions of the FDA Device Accountability Act of 2015, Promoting Biomedical Research and Public Health for Patients Act, and FDA and NIH Workforce Authorities Modernization Act.
A February 2 article in Bloomberg BNA's Privacy Law Watch and other publications, "Hospital Hit With $3.2M Penalty for Ongoing Health Data Security Lapses," reported that Children's Medical Center of Dallas received a $3.2 million civil money penalty after years of noncompliance with HIPAA rules and after failing to request a hearing on the penalty.
The 21st Century Cures Act includes portions of the Helping Families in Mental Health Crisis Reform Act of 2016, which was approved by the US House of Representatives in July 2016, but not advanced by the Senate.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).