Issues & Legislative Committee Report

December 14, 2006

JCAHO/Gainsharing Update

Gainsharing Agreements

OIG Advisory Opinion No. 06-22 written on November 9, 2006, posted on November 16, 2006. This opinion again deals with an arrangement with cardiac surgeons having the opportunity to share cost savings that are achieved by a hospital with their assistance.The opinion states that 24 savings opportunities were identified at the requesting hospitals cardiac surgery department. These are in three categories: (1) limiting supplies such as Aprotinin to high risk patients rather than general population, (2) substituting less costly items, and (3) product standardization where appropriate.

Source: http://oig.hhs.gov/fraud/advisoryopinions/opinions.html

The Joint Commission (JCAHO)

Our committee discussed vendor rep certification in the operating rooms. There was some thought that perhaps JCAHO was moving toward requiring some type of certification for reps that are in the OR suites. The JCAHO requirement was not confirmed although some of the hospitals in which committee members work have their own orientation and/or certification process for reps.

Quality, Medication Errors and Safety Issues

18th National Forum on Quality Improvement in Health Care

The Institute for Healthcare Improvement (IHI) has hosted the 18th National Forum
on Quality Improvement in Health Care in Orlando, FL from Decemeber 10-13, 2006.
It attracts healthcare leaders from around the world both in person and via satellite.
The goal is to improve the safety and effectiveness of healthcare delivery in the
U.S. and globally. 

Source: HPN Online, November 22, 2006.

IHI Expands Patient Safety Goals

The new campaign is aimed at getting 4,000 hospitals to implement up to 12 patient-safety “interventions with the overall goal of protecting 5 million patients from harm over the next 2 years. Six of the interventions are from the IHI’s previous 100,000 Lives campaign. The new initiatives are: deliver evidence-based care for congestive heart failure; make hospital Boards more effective in accelerating improvements; prevent harm from high-alert medications; prevent pressure ulcers; reduce surgical complications; and, reduce infections from methicillin-resistant Staphylococcus aureaus.

Source: Andis Robezniekes, Modern Healthcare Daily Dose, December 12, 2006.  

Medication Errors

The Pharmaceutical Safety Institute announced the launch of its organization and informational website at www.psisafety.org to restore and maintain consumer confidence in medicines worldwide.

Source: HPN Online, November 30, 2006.

Safety Issues

There are continued concerns about drug eluting stents exist causing a slow down in the purchase and use of these stents. Cables and electrodes can burn patients undergoing an MRI (magnetic resonance imaging) according to reports received by the Food & Drug Administration (FDA). Second and third degree burns were discovered after MRIs. The radiofrequency fields that occur during an MRI can heat EKG cables and electrodes seriously burning the skin under the electrodes. Steps to be taken are listed in "Nursing 2006", Volume 36, Number 11.

Source: HPN Online, November 28, 2006.

New Fire Safety Tool Kit

Also, to help further the goal of patient safety, MegaDyne and AORN partnered to promote Fire Safety in the OR. A “Fire Safety Tool Kit” has been developed which includes a DVD on surgical fires, a fire drill and evacuation plan, interactive software, sample policies, posters, and literature. In addition, Megadyne sponsors three continuing education courses: Electrosurgical Patient Safety: You Are the Key, Laparoscopic Electrosurgical Safety, and Preventing Surgical Fires. 

Source: HPN Online, December 11, 2006.

Ethics/Pharmaceutical and Vendor Gifts

On October 18, 2006, "The New York Times" reported on the guilty plea made by former FDA Commissioner Lester Crawford to lying and conflict of interest charges. He admitted to owning stock in Pepsico and Sysco, while chairing the Obesity Work Group for FDA, which was reviewing the calorie-content labeling for soft drinks. Crawford could face up to a year in prison and a fine of up to $100,000, although his lawyer expects him to be placed on probation.

According to a recently conducted Internet survey reported by the Associated Press, 39 percent of the scientists currently doing active  research for NIH are now considering pursuing other employment as a direct result to new ethics guidelines being placed upon them. These new regulations have curtailed their ability to earn outside income, and the scientists consider the ethics crackdown to be too severe.  There is also concern that these new rules will hamper the ability of NIH to conduct research. The scientists are no longer allowed to serve as consultants for industry, and they are under greater financial disclosure requirements than previously.  However, it is not anticipated that these regulations will be revised, and many NIH employees are hopeful that these tighter rules may improve public opinion with
the agency.

The Associated Press also reported on the case of a pharmacist who served as Chief pharmacist for the Pennsylvania Public Welfare Department who used his position to gain consulting work. He served as a consultant for Pfizer and Janssen, and presented at conferences funded by these companies. In one case, he presented a state funded study on antidepressants, which found Zoloft (a Pfizer product) to be among the least expensive drugs of this class. In November 2006, he was charged with two felony counts of conflict of interest that carry potential prison time and released on his own recognizance.

On November 29, 2006, the Associated Press reported on a study published in the "New England Journal of Medicine" of a survey of university hospital review boards (IRB’s) and the ties of their members to drug and medical device companies. One third of all members of the IRB’s in 100 of these medical centers were shown to accept funds from these companies in the way of royalties, consulting fees and other benefits. Many of those with conflict of interest have not disclosed these ties.  Members of IRB’s are prohibited from voting in studies in which they have a conflict of interest by federal law, but this is rarely enforced.

In the ongoing review of the efficacy of drug eluting stents, it was revealed that six of the physicians chosen to serve on an FDA advisory panel reviewing post stent clot formation have financial ties to Johnson & Johnson. In order to get the input of these physicians, the FDA is waiving requirements preventing involvement from scientists that have stock ownership or consulting arrangements. Senator Charles Grassley is concerned, claiming that only scientists without financial conflicts should be involved.  The FDA claims that the expertise of these six physicians outweighs concerns over their financial connections with the stent manufacturer.

Sources:
(1) Goldstein, Avram. “FDA Stent Experts have Financial Ties to J&J, Rivals
(Update 2)”, Bloomburg.com. December 4, 2006.
(2) Jackson, Peter. “Criminal Charges are Filed Against a Former State Pharmacist”,  Associated Press; York Dispatch. November 22, 2006.
(3) “NIH’s New Ethics Rules Lead Some to Ponder Jumping Ship”. Associated Press; HPN Update, November 2, 2006.