Issues & Legislative Committee Report

April 12, 2007

JCAHO / GPO Oversight Committee

JCAHO Report
Recently recognized as an accreditor by the Centers for Medicare & Medicaid Services (CMS) for providers of durable medical equipment, prosthetics, orthotics, or supplies seeking Part B Medicare reimbursement.
 
Is continuing its development of a white paper addressing Reducing Waste in HealthCare and Improving Efficiency.  The goal is reduction of the perceived 30-40 cents of waste built into every dollar of health care spending.  Though most of the review is systems oriented, a Lean perspective should flush out at least some supplies and devices recommendations.
 
Announced one-day conferences in May and November on Strategies for Successful Medication Reconciliation.
 
Announced its participation at the 15th World Congress for Disaster and Emergency Medicine, May 13-16.  Will present jointly with the Yale New Haven Center for Emergency Preparedness and Disaster Response a 2-day emergency preparedness workshop.
 
GPO Oversight Report
On March 7 Senator Orrin Hatch, one of two senators assigned to ongoing Healthcare GPO Oversight, praised the enforcement efforts of both the Antitrust Division and the FTC, citing in particular the areas of corporate mergers and and the energy market.  He did not mention healthcare.

Gainsharing Agreements

In a recent article by Ernst & Young LLP , they noted that Pay for Performance and Gainsharing are among the key issues that will shape 2007 for the healthcare provider industry.

As healthcare payers look to incentivize doctors and hospitals based on quality and safety performance these programs are emerging. The Centers for Medicare and Medicaid Systems (CMS) will implement a “pay for performance” program in 2007, under which doctors serving Medicare patients can qualify for a 1.5 percent bonus if they report data on the quality of care, using measures specified by the government.
Source: http://www.ey.com/global/content.nsf/US/Media_-_Release_-_01-08-07ADC

Ethics / Pharmaceutical and Vendor Gifts

Companies should create strong policies to monitor and regulate compliance with the Foreign Corrupt Practices Act (FCPA), as the number of cases in the healthcare industry is growing. Under the FCPA, any gift given to a foreign public official to obtain or retain business is illegal. Importance for healthcare companies: the Department of Justice considers employees of government institutions, such as physicians in government hospitals, to be public officials.

RECOMMENDATION
Each company must create a compliance program instead of just making policy statements. This means companies should have detailed guidances, with steps and actions outlined.

Controls are the most important part of a compliance system. Companies should focus on developing and communicating clear policies, along with establishing regular training, certifications and audits to ensure the programs are working correctly.

Company programs should also include reporting systems, where senior management reports on FCPA compliance status to audit committees and employees are disciplined when violations are found.

Companies should use several training methods for their employees, including online training, which can be particularly useful for third-party agents. Agents who are working on the company's behalf should receive some level of training to become familiar with the company's FCPA procedures. Other third-party agents, such as distributors, do not need to know as much about the procedures, but should fill in certifications they will abide by. The company can also audit these parties to get more information and can readily track training compliance.

DRIVE TO SELF-REGULATE
The International Federation of Pharmaceutical Manufacturers and Associations has launched an on-line service for ethical drug promotion on its web site (www.ifpma.org/ethicalpromotion). The Geneva, Switzerland-headquartered organization explained that the move is a progressive step in a continuous process, following as it does the January 1, 2007, entrance into effect of the IFPMA Code of Pharmaceutical Marketing Practices.

In the United States there is additional interest in greater oversight and enforcement of  FCPA by Department of Justice. Accounting practices may require updates under SOX.

Infection Control

The CDC has reorganized the Coordinating Center for Infectious Diseases into a new organizational structure which should put it in a better position to “prevent infectious diseases and to respond to international emerging threats”.  There will be four national centers dealing with infectious diseases, and which will be separated in terms of the diseases they will address, i.e. separating blood borne diseases from enteric and vector borne disease.

As Related to Global Warming
On 4/2/07, Healthcare Purchasing News reported on two viral borne illnesses that seem to be increasing due to climate changes. The first are  the hantaviruses, which are spread by rodents.  They infect humans when mouse droppings of infected mice are disturbed and the virus is released into the air.  The virus can cause a serious to deadly hemorrhagic fever with renal syndrome.  There has been a world wide increase in the incidence of these viruses with the advent of unusually warm winters and resultant large populations of mice.  This has been noted in New Mexico and surrounding states, as well as China, Korea, Northern and Western Europe, Argentina, Chile, Brazil, Panama and Canada.  There have been 20,000 cases reported in Russia alone this year.

The second virus that seems to be on the rise is a hemorrhagic form of Dengue fever, which is sweeping through Latin America and Mexico.  The CDC has noted that this is more common in the Americas than the rest of the world.  This is a mosquito borne illness that may be increasing due to longer rainy seasons, and more trash that traps water. Latin American hospitals are not equipped to deal with major outbreaks, and it is hitting the tourist and migrant populations via the uncontrolled mosquito populations.    There are two four strains, which result in either the classic form or hemorrhagic forms.  The only real treatment is rest and palliative care.  Of big concern are travelers who return to their county of origin, where this illness may go undiagnosed.

Resistant Organisms
Clostridium difficile occurs in every one out of three hospital acquired illnesses.  It is an epidemic which is increasing in incidence and severity world wide, and is characterized by the emergence of a highly virulent and resistant strain.  It is spread in the hospital by contact  with contaminated surfaces, hands, and stool.  Failure to use good hand washing practices is one of the primary contributors to the spread in the hospital setting. 

XDR-TB is a newly emerging strain of TB that is very resistant to the most important drugs that have been traditionally used to treat TB.  It is considered to be “grave public threat” by the World Health Organization, since it is deadly to those who have HIV.  It is most common in the developing nations, but has also been identified in Europe and the United States.  The concern is that it could present potential problems to others who have compromised immune systems, such as those with cancer.  As with other drug resistant organisms, this one probably developed due to inappropriate use of antibiotics.  There are ethical concerns now that there might be forceable quarantines being used.  There was one report in the Arizona Republic of a man who has been kept isolated for 8 months by the Sheriff’s department.  Having XDR-TB, he violated the terms of his voluntary quarantine, and has been incarcerated in a hospital. 

Lessons learned from SARS
The Infectious Diseases Society of America has reported on a study that looked at the spread of respiratory diseases in hospitals, which based its findings on the 2003 SARS epidemic in China.  It found that hospitals can be a “breeding ground for infectious disease, which can exacerbate a respiratory epidemic.  The tendency during an epidemic is to try to increase hospital beds to accommodate the ill, but decreasing the proximity between patients increases cross transmission.  Oxygen therapy also exacerbates the spread, since it is thought that the treatments may propel infectious droplets further into the air.  It is essential that the health care workers have adequate hand washing as well as showering and changing facilities to reduce nosocomial transmission.

Sources:
Altman, Lawrence.  “Rise of a deadly TB reveals a global system in crisis”.  New York Times, 3/20/07.
HPN Daily Update:  “Russia see ill effects of “General Winter’s” retreat”.  4/2/07.
HPN Daily Update:  “Dengue surging in Mexico, Latin America”.  4/2/07.
HPN Daily Update:  “Severe dengue infections may go unrecognized in international travelers.”  4/2/07.
HPN Daily Update:  “HHS makes CCID organization official.”  3/26/07.
Infection Control Today:  “Leading experts call for immediate improvement to control global epidemic of Clostridium difficile- associated diseases”.  4/3/07.
Wagner, Dennis.  “Quarantine breach leaves TB patient locked in isolation”.  Arizona Republic:  3/1/07.

Quality / Medication Errors / Safety Issues

Safety Issues
March 2007 – Center for Drug Evaluation & Research (CDER)
FDA approved safety labeling changes for 40 medications. Changes include: boxed warning, contraindications, warnings, precautions, adverse reactions, or patient package. The medications include Ambien, Prilosec, Detrol LA, Prozac, Toprol-XL, Lipitor, Zelnorm, and Zyban. http://www.fda.gov/medwatch/safety/2007/mar07_quickview.htm

April 2007 – Warning on Using Cough & Cold Medicines in Young Children
CDC article cites over 1500 cases in which children less than 2 years of age were treated in emergency rooms for adverse events associated with these drugs. Instructions on OTC cough/cold medications advise consumers to consult a doctor for children under the age of 2 years. Due to risks of toxicity, CDC advises caution when prescribing these medications to any child under the age of 2 years.  http://www.accessdata.fda.gov/scrips/cdrh/cfdocs/psh/transcript.cfm?show=62

Medication Errors
March 7, 2007 – California
Medication Errors Panel – created through legislation. The panel consists of healthcare, consumer advocacy, and academic representation. Recommendation includes:
-  Adding the purpose of a pill to the prescription label
-  Label bottles in different languages
-  Creating public education campaign
-  Establishing a state funded project to collect data on the prevalence of medication errors at pharmacies in California.

Gov. Schwarzenegger’s health care reform proposal has some of the recommendations listed above. It seeks to reduce medications errors by:
-  Pushing hospitals and clinics to adopt, by 2008, Safety measures related to infection control, surgical errors and adverse drug events
-  Enacting a new reporting requirement
-  Establishing an Office of Patient Safety within the Department of Public Health (3/7/2007)
www.californiahealthline.org/articles/2007/3/7/report-lays-out-Recommendations-to-curb-medication-errors.aspx

Ethics/ Non-Pharmaceutical Vendor Conduct

In late March the Miami Herald reported that, due to questionable sales ethics, Jackson Memorial Hospital (Florida) has formally put St. Jude Medical Inc. on probation.  As of the date of publication, St. Jude declined to comment stating they had yet to receive the March 28th correspondence which defined the probation period and limitations set by Jackson Memorial.  The probation is the first course of action stemming from a December 2006 investigation citing a $2 million hike in Jackson’s St. Jude Cardiac Rhythm Management purchases.  This 400 percent increase in St. Jude CRM purchases happened shortly after cardiologist Alberto Interian Jr.’s girlfriend was hired by St. Jude Medical Inc.  The University of Miami cardiologist suggested the rise in utilization of these devices costing up to $28,000 each is a coincidence and has been found innocent of unethical behavior by his medical school.

Stipulations from Jackson Memorial Hospital to St. Jude:
1. St. Jude must return the rep’s (Monica Rodriguez) vendor identification badge
2. All St. Jude sales reps must complete Jackson’s “corporate compliance training”, “procurement ethics training” and “complete the county’s rigorous lobbyist registration”.
3. If the stipulations are not met, Jackson will begin banning St. Jude Medical’s most expensive devices in the facility.

The facilities’ spokesperson stated that although St. Jude Medical was the first requested to comply, all vendors will soon be required to attend vendor ethics training.  In addition to that, he cited the hospital is migrating more towards a closed campus to make such a violation more difficult and more identifiable in the future.

UPN Issues / Data Standards Issues

Healthcare Supply Chain Standards Coalition (HCSCS)
AHRMM’s member representative and staff continue to participate in HSCSC subcommittee meetings to advance the standardization movement. The Oversight Committee (on which AHRMM has a non-voting observer seat) is getting closer to selecting a standard to advocate to the healthcare industry; hopes are that a decision will be made at the May 7 meeting, but latest information suggests that it will not be voted on at the actual meeting. The Oversight Committee received many nominations for Chair. Elections will be held via email by April 27. The Organizational Identifier subcommittee has gathered information and sought presenters on the two leading identifiers, the HIN and GLN. The Data Synchronization subcommittee is working to establish a model for a utility to synchronize product information. The Education and Enablement Committee is working on a plan to market to distributors, manufacturers, providers, including CEOs and IT folks within hospitals. The next Oversight Committee meeting will be Monday, May 7, 2007 from 10 am - 4:30 pm in Chicago.