New, revised pain assessment/management standards for behavioral health care, home care, nursing care to be introduced

 Effective July 1, 2019, new and revised pain assessment and management standards will be applicable to Joint Commission-accredited behavioral health care, home care and nursing care center programs. 

The program-specific standards follow new and revised pain assessment and management requirements for hospitals, ambulatory health care organizations, critical access hospitals and office-based surgery practices that The Joint Commission introduced earlier this year. 

To help health care organizations better understand and comply with the updated standards, The Joint Commission has released three new R3 Reports to provide in-depth rationale, references and evidence that guided the development of the new and revised requirements: 

The updated standards were developed based on public field review and expert guidance from a technical advisory panel, program-specific expert panels and program-specific standards review panels. They are designed to provide contemporary guidance for pain assessment and management, as well as to strengthen organizations’ practices for pain assessment, treatment, education and monitoring.

The Joint Commission's news item and reports can be found at this link.  

Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures 

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also making additional changes unrelated to the FDASIA requirements, to update its regulations governing the classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to the classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.

The full pdf can be downloaded below.  

Slides from 12.17.18 webinar.

While the weather outside is frightful, policy is so delightful! Santa’s sleigh is packed full of policy presents for 2019, with a new Congress and regulations galore. 

Join eHI on December 17 for a cozy fireside chat about federal health IT priorities in the new year and big changes afoot with:
-Post election policy shifts and a 2019 forecast
-Key leadership changes in Congress that affect health IT and your organization
-Pending government rules, including the ONC information blocking NPRM related to 21st Century Cures
 

Speakers:

-Leigh Burchell, Vice President, Policy and Government Affairs, Allscripts
-Cherie Holmes-Henry, Vice President, Government and Industry Affairs, NextGen Healthcare

Moderated by:
-Ticia Gerber, Senior Policy Advisor, eHealth Initiative

Considering Heroin-Assisted Treatment and Supervised Drug Consumption Sites in the United States

Current levels of opioid-related morbidity and mortality in the United States are staggering. Data for 2017 indicate that there were more than 47,000 opioid-involved overdose deaths, and one in eight adults now reports having had a family member or close friend die from opioids. Increasing the availability and reducing the costs of approved medications for those with an opioid use disorder (OUD) is imperative; however, jurisdictions addressing OUDs and overdose may wish to consider additional interventions. Two interventions that are implemented in some other countries but not in the United States are heroin-assisted treatment (HAT; sometimes referred to as supervised injectable heroin treatment) and supervised consumption sites (SCSs; sometimes referred to as overdose prevention sites). Given the severity of the opioid crisis, there is urgency to evaluate tools that might reduce its impact and save lives. In this mixed-methods report, the authors assess evidence on and arguments made about HAT and SCSs and examine some of the issues associated with implementing them in the United States.

The full RAND Corporation report can be downloaded below.  

Prominent Doctors Aren’t Disclosing Their Industry Ties in Medical Journal Studies. And Journals Are Doing Little to Enforce Their Rules

One is dean of Yale’s medical school. Another is the director of a cancer center in Texas. A third is the next president of the most prominent society of cancer doctors.

These leading medical figures are among dozens of doctors who have failed in recent years to report their financial relationships with pharmaceutical and health care companies when their studies are published in medical journals, according to a review by ProPublica and The New York Times and data from other recent research.

In addition to the widespread lapses by doctors, the review by ProPublica and The Times found that journals themselves often gave confusing advice and did not routinely vet disclosures by researchers, although many relationships could have been easily detected on a federal database.

Medical journals, which are the main conduit for communicating the latest scientific discoveries to the public, often have an interdependent relationship with the researchers who publish in their pages. Reporting a study in a leading journal can heighten their profile — not to mention that of the drug or other product being tested. And journals enhance their cachet by publishing exclusive, breakthrough studies by acclaimed researchers.

In all, the reporting system still appears to have many of the same flaws that the Institute of Medicine identified nearly a decade ago when it recommended fundamental changes in how conflicts of interest are reported. Those have yet to happen.

The full ProPublica article can be viewed at this link.  

9 major institutions create healthier environment for physicians: Best Practices

About half of physicians report at least one symptom of burnout, which is nearly twice the rate of other American workers. As burnout continues to receive growing attention, more health care organizations and institutions are searching for solutions to improve physician well-being. This year, nine institutions stood out for their commitment to preventing and alleviating physician burnout.

Committed to making physician burnout a thing of the past, the AMA has studied, and is currently addressing, issues causing and fueling physician burnout—including time constraints, technology and regulations—to better understand the challenges physicians face.

Best Practices

• Group meetings - Mayo Clinic found that giving physicians a way to gather in small groups for semistructured, private discussions in restaurants, coffee shops or reserved rooms results in measurably lower burnout and social isolation, and higher well-being and job satisfaction.
• Banking overtime - Inspired by the idea of faculty trading favors with colleagues to meet the time demands of work and home, time banking for doctors began as a two-year study at Stanford University School of Medicine to help improve physicians’ lives to minimize burnout-induced departures. 
• Team-based care model - Since implementation in 2014, Bellin Health has seen a significant reduction in burnout across all staff, as well as improvement in patient satisfaction and quality of care. 
• System changes - Leaders at Carilion Clinic—after finding that nearly three in five physicians reported burnout—have pursued seven innovative ideas and initiatives to address burnout. These range from a central well-being committee to put the issue at the top of the agenda to support for interdepartmental exchange of effective ideas to improve well-being.
• Ease click fatigue - To improve physician well-being and prevent burnout, Yale School of Medicine searched for ways to reduce clicks and increase time spent with patients.
• Create a culture of caring and meaning in work - Henry Ford hospital implemented several burnout prevention strategies focused on establishing a culture of caring and creating meaning in work. These include “monthly wellness rounds” educational sessions on topics related to physician well-being.
• Prioritizing physician well-being - Leaders at University of Utah Health (UUH) initiated a multifaceted assessment to help guide their efforts in addressing burnout. Part of the response came in the form of a chief wellness officer and a faculty co-director of the UUH Resiliency Center meeting individually with leadership from each department within the medical school to identify opportunities for improvement.
• Address barriers to team-based care - This care model can drive increases in physician well-being, but obstacles to team-based care had to first be overcome at Cleveland Clinic. These include patient reluctance, physician apprehension and financial concerns. 
• Stress-reducing events - Through monthly wellness events and weekly emails, residents and clinical fellows at Johns Hopkins participate in a variety of activities aimed at improving well-being across the campus.

The full AMA article (with links to detailed information about each of these best practices) can be viewed here.  

Statement from FDA Commissioner on transformative new steps to modernize FDA’s 510(k) program to advance the review of the safety and effectiveness of medical devices

Forty-two years ago, Congress passed the law establishing the framework for evaluating the safety and effectiveness of medical devices. Today, we’re announcing changes to modernize the FDA’s 510(k) clearance pathway, which accounts for the majority of devices that the FDA reviews. We’re pursuing these changes to help keep pace with the increasing complexity of rapidly evolving technology. The new technology that we’re seeing holds tremendous public health promise for patients. But with the advances also come new complexities that can make the review of safety and effectiveness more challenging. The framework we propose is aimed at efficiently advancing beneficial technology to patients, while solidifying FDA’s gold standard for safety.

We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria. We want to make sure that new devices are evaluated against advances in technology that can improve patient safety and performance. In making these reviews, where appropriate, we want to rely on modern safety and performance criteria. At the same time, we’re going to pursue additional actions that will allow the FDA to retire outdated predicates, especially in cases where we’ve seen safer or more effective technology emerge. 

We believe firmly in the merits of the 510(k) process. But we also believe that framework needs to be modernized to reflect advances in technology, safety and the capabilities of a new generation of medical devices. In short, we believe that it’s time to fundamentally modernize an approach first adopted in 1976, when Congress considered the vast diversity of devices that would become subject to the FDA’s regulatory oversight and established many of the predicate devices that served as the basis for 510(k) clearances during the last 40 years.

The full press announcement can be found at this link.