Issues & Legislative Committee Report

May 10, 2007

JCAHO / GPO Oversight Committee

Joint Commission
The JC has just announced accepting a Robert Wood Johnson Grant to study Smoke-Free Hospital Campuses.  They believe they'll be polling most hospitals in the U.S.  Focus this time is not just on smoke-free hospitals, but entire campuses--policies, implementation, enforcement, etc.
 
The World Health Organization has just announced "Nine Life-Saving Patient Safety Solutions" that were identified by its Collaborating Center for Patient Safety Solutions (which is JC).  The solutions are look-alike, sound-alike medications; patient identification; hand off communications; correct procedure-correct body site; control of concentrated electrolyte solutions; medication accuracy; cath and tubing mis-connections; needle reuse and safety; and hand hygiene.
 
GPO Oversight
In response to proposed CMMS cuts in the recent "Medicare Trustee's Report," HIGPA re-asserted the need for stronger Medicare/Medicaid programs, not weaker; and reminded the group of the important cost savings being contributed by the GPO industry.
 
In addition, earlier this year HIGPA had responded to the proposed HMMS Final Rule by re-arguing that GPO Fees do not constitute "price concessions," and therefore should not be factored into "Average Sales Prices" (ASP) for drugs and biologicals.  HMMS calls fees price concessions because most GPO's distribute at least part of their fees back to member hospitals.

Gainsharing Agreements

A very well written article by Christopher Guadagnino, Ph.D. recently appeared in the Physicians News Digest. The following are excerpts from that article which I would encourage everyone to read in full. In the following excerpts, the focus was on the results of the original program as well as a few of the CMS gainsharing demonstration project applicants.

PinnacleHealth System in Harrisburg, Pa., has achieved clinical care improvement and a level of collaboration with physicians that transcend the monetary savings accrued from the arrangement, according to President and CEO Roger Longenderfer, M.D.

In the three years Pinnacle has run the gainsharing program – involving Harrisburg Hospital and three cardiology group practices representing about 50 physicians – the organization saved about $2.5 million by focusing on cost and best practice utilization of cardiac devices such as bare metal and drug eluting stents, pacemakers and implantable defibrillators.

Pinnacle has seen its strongest economic return in the first couple of years, while some of its subsequent cost savings goals have not been met, after the "low hanging fruit" – such as better contract pricing – had been picked, says Longenderfer. "Your baseline keeps changing, and you must look for new and innovative changes. But, technologies keep changing too, and it’s an ongoing and constantly challenging process to control the inflation of costs," says Longenderfer.

“I have always felt that gainsharing was a little about economics and a lot about physician-hospital quality improvement – sharing data. That has always been the underlying motive for us," says Longenderfer, noting that cardiac cath lab complication rates continue to decrease since the program began.

Gainsharing Demonstration Project
PinnacleHealth System, northeastern Pa.’s Geisinger Health System, and a consortium of 12 New Jersey hospitals have all applied for a CMS gainsharing demo project.

Pinnacle’s proposal applies to general internists and seeks to find ways to provide better case management of patients with diabetes, COPD and pneumonia – both in physician offices and in the hospital, says Longenderfer. Pinnacle hopes a collaboration with physicians will lead to fewer hospital readmissions, shorter lengths of stay, and better selection of antibiotics and other drugs, he adds.

Geisinger Health System has applied for approval of a Medicare gainsharing project that will expand a successful cardiac surgery quality improvement program to eleven high-volume inpatient surgical and interventional procedures. Essential to the infrastructure of the project is an electronic health record, which enables pre-admission risk assessment and documentation flowsheet.

NJHA will have a global steering committee that will serve as a forum to share best practices across physicians at the 12 participating hospitals, from both a clinical and nonclinical perspective, to help them work toward the target norm, says Hopkins.
Source: http://www.physiciansnews.com/cover/507pa.html

Pricing Confidentiality / Transparency

The largest U.S. makers of artificial knees and hips are facing an investigation by federal prosecutors, who say that the companies illegally paid off surgeons with vacations, gifts and no-show consulting jobs in an effort to win their business. Manufacturers targeted include Johnson & Johnson subsidiary DePuy Orthopaedics, Zimmer Holdings, Biomet, Stryker and Smith & Nephew. Federal prosecutors suggest that such payments constitute a kickback, as they're provided solely to buy surgeons' business. Most of these companies are close to settling with federal authorities, other than DePuy Orthopaedics, which has pushed back in talks. Observers expect settlements, which would be paid to Medicare, to hit as much as a half-billion dollars. Meanwhile, medical societies continue to tighten up their ethical guidelines regarding payoffs from medical device makers.

Source: Federal Probe: Implant Makers Bought Doctors - May 08, 2007 http://www.healthdecisions.org/News/default.aspx?doc_id=117443

Quality / Medication Errors / Safety Issues

Safety Briefs
“No FDA Guidance on drug concentration expressions”
An order was received in the pharmacy for 40 mg IV now of Zemuron. Both the pharmacy technician and pharmacist read display on box as 10 mg/ml and filled order with 4 vials. Actually vials contained 10ml with a total of 100mg per vial. The total volume in each vial was probably missed because this information does not appear within the box that lists the concentration. (ED nurse recognized the mistake before administering the drug)
This problem, which is well known to the FDA, has not been addressed by the FDA. This error-prone condition has caused some patient injury and/or death. If possible, pharmacy staff should circle any important information on the carton label that is not prominent to bring attention to it.
www.ismp.org/Newsletters/acutecare/articles/actionagenda0702.doc

Medication Briefs
“Antidepressant Medication products 5/2/2007”
The FDA notified healthcare professionals and proposed that makers of all antidepressant medications update box warnings to include warnings about the increased suicidal thinking and behavior in ages 18-24 during the first one to two months of treatment. Manufacturers have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review.
www.fda.gov/cder

“Sleep disorders Medications” (Ambien, Lunesta, Restoril)
FDA is asking all manufacturers of these drugs to strengthen the language in product labeling to include:
(1) severe allergic reactions
(2) unusual behaviors
The manufacturers will also be developing Medication Guides to be given to patients whenever the drug is dispensed.

“Smart Pumps – Are not smart on their own”
The role of smart pumps is to “remember” the large number of rules “dosing limits) entered into the drug library and apply these rules during pump programming to warn clinicians about potential unsafe drug therapy.
Equally important, the role of the clinician is to USE the technology consistently – and not bypass the established rules. A culture of safety must exist that drives all clinicians to avoid bypassing such a safety feature. A culture of safety also promotes the critical thinking needed to evaluate pump alerts from both a clinical and safety perspective.
www.simp.org/Newsletters/acutecare/articles/actionagenda0702.doc

Alabama Hospital Association (attachments included with this report)
www.alaha.org

Medication Safety Tips 
Universal Medication Form 
Medication Safety Tool Kit 

Disaster Preparedness & Surge Capacity – Their Associate Costs

A review of the Joint Commission’s 2007 Hospital Accreditation Standards under the Environment of Care reveals the following:

Standard EC.4.10 “The Hospital Addresses Emergency Management”.  Under this standard, an Element of Performance maintains that a hospital maintains an emergency management plan (EP3) and under that plan specific procedures describe “…preparedness, response, and recovery strategies, actions and responsibilities for each priority emergency” (EP5).  The plan must also provide the process for managing the following under emergency conditions:
“Activities related to care”
“Treatment and services”
“Staff support activities”
“Logistics relating to critical supplies” (EP10). 

The plan must provide a process for establishing an alternate care site (EP13).

The plan must also provide a process for cooperative planning with other healthcare organizations that service a community (therefore potentially sharing resources and assets during an emergency response)
~Jeff Wagner commented on upcoming exercise that they were going to participate in.
~ Part of the discussion centered on the general lack of “defined” type of All-Hazards disaster to prepare for.  In this sense what is the implied and specified task’s that the Supply Chain Manager needs to forecast?
~ The following standard refers to the number and type of exercises that facilities need to participate in: 
Standard EC.4.20 “Number and Type of Exercises”.  Under this standard, and specifically EP10, the Scope of an exercise must also monitor the following core performance areas:
“Resource mobilization and allocation, which includes responders”
“Equipment”
“Supplies”
And “Personal Protective Equipment”
~ The key point here is the process for mobilizing, staging and processing resources, material, transportation, personnel, etc. must be exercised in either a walk-thru of all the steps, points of contact, staging areas, to see what areas are deficient and need additional work and procedural updates.  Requirements are reviewed and updated.  Assets currently on hand are inventoried for efficacy.  Additional assets are coordinated, in some cases, contingency contracts established to activate against a rapid increase of consumption and demands.  Transportation routes are reviewed for trafficability. 
~ An additional point in this planning and execution of exercises is to conduct a dry run of any mutual aid agreements with other facilities in the area or region.  Coordinated dry runs will assist the material manager and emergency planner to identify where shortfalls could occur in either response time, or having the correct material postured for response or the delivery of material to a specified location or area.

Green / Environmental Friendly Purchasing

Environmentally friendly purchasing has been in Healthcare for several years, Federal and Local agencies have operated under a series of Federal statutes and Presidential Executive Orders mandating the purchase and services that place fewer burdens on the environment.  The implied mission of healthcare providers is to improve the health of people and communities we serve.  It is becoming widely known that many of the medical products we buy , and practices we engage in, can cause damage to the environment and/or public health.

As a result, in June 199, the American Hospital Association signed a Memorandum of Understanding (MOU) with the U.S. EPA in consultation with Health Care Without Harm, agreeing to work in voluntary partnership to:
• Virtually eliminate mercury waste generated by hospitals by 2005;
• reduce overall hospital waste volume by 33% by 2005 and by 50% by 2010; and
• Jointly identify additional substances to target for pollution prevention and waste reduction opportunities.

The Environmentally Preferable Purchasing (EPP) Work Group is one of twelve work groups established to implement the MOU.  To assist health facilities in identifying and buying environmentally preferable products, the EPP work group has:
• Written a “How-To Guide” on EPP for Hospitals.
• This web-based guide introduces EPP, describes why Hospitals should be doing EPP, and takes a hospital from EPP team formation to the completion of a pilot EPP project.  The Guide also includes information on overcoming obstacles, tracking success, creating publicity, negotiating with Group Purchasing Organizations, and evaluating the validity of vendor claims.
• Produced a list of resources on EPP for hospitals.
• Created a matrix of educational needs on EPP for hospitals personnel and also for those outside the hospital.
• Created a draft presentation on health care EPP.

The EPP Work Group is currently:
• Compiling a specifications database of environmental purchasing policies and specifications used in hospital RFP’s or purchasing contracts.
• Updating and expanding the presentation on health care EPP.
• Developing a list of speakers with expertise in health care EPP.

All of these materials are available on the web at: http://www.geocities.com/EPP_how_to_guide/

The EPP Work Group’s charge is to:
•  Investigate, prioritize and implement strategies to promote the role of EPP in hospital procurement.
•  Identify and collect existing resources on environmentally preferred products.
•  Determine, in consultation with the model plan work groups, product categories to target and prioritize.

Contact Information for Work Group Participants is available at the website.

UPN Issues / Data Standards Issues

The Oversight Committee of the HSCSC met on May 7th In Chicago. Although significant progress has been made regarding choosing an organizational identifier as a standard, the Committee was not ready to vote to endorse one at the meeting. An invitation has been issued for a presentation by HIBCC on the HIN. The education subcommittee has drafted a marketing plan, but is awaiting budget confirmation. The PDU committee is reviewing the data coming out of the trials being conducted around the country.  The subcommittees meet bi-monthly, and the next full oversight meeting is scheduled for July.