Issues & Legislative Committee Report

June 14, 2007

JCAHO / GPO Oversight Committee

JCAHO Report
Due to heavy negative feedback from members, JC has suspended its Interim Action for Standard MM.4.10, requiring retrospective review of all medication orders in the Emergency Department by a pharmacist when a prospective review is not done.  Instead the standard will hold to its prospective review requirement, but with the following two exceptions:
1) Medications may be ordered and administered by a Licensed Independent Practitioner (PA, RN, RTs, etc).
2) Medications may be ordered and administered without a pharmacist's review for urgent situations in which a patient may be harmed by delayed action.

GOP Oversight Report
No new statements from any of the main players.  Senator Kohl continues to display his "concern that group purchasing organizations reduce market competition" statement on his Judiciary Committee web page.

Gainsharing Agreements

The OIG issued their list of unimplemented recommendations, and those below are what they refer to as “priority recommendations” as they represent the most significant opportunities to positively impact the Department’s programs according to the OIG. There are three categories reflected; Savings; Integrity and Efficiency; and Quality of Care.

In the area of Savings, two of those identified were (1) “Requiring that Medicaid Reimbursement for Brand Name and Generic Drugs Accurately Reflects the Pharmacy Acquisition Costs, estimated savings of $1.8 billion for brand name drugs and $470 million for generic drugs.” And (2) “Establish Connection Between the Calculation of Medicaid Drug Rebates and Drug Reimbursement, estimated savings of $1.15 billion.”

In the area of Quality of Care, “Strengthening Food and Drug Administration Oversight of Clinical Investigators” stood out among the rest.

Source: http://www.oig.hhs.gov/publications/compendium.html
 http://healthblawg.typepad.com/healthblawg/2007/06/oig_issues_the_.html

Consumer Driven Healthcare

1. FDA link for consumer information
WWW.FDA.GOV/consumer
2. Wal-Mart, announced that they would open 2000 clinics during the next five years.  Wal-Mart will contract with providers for these clinics.  They currently have 76 clinics in place.
3. Wal-Mart cut price for generic drugs to $4.00 per prescription.
4. Walgreen purchases Take Care Health Systems to open 400 in store clinics by 2008 to compete with CVS’s in store clinics.
5. Medical Home – using primary physicians to coordinate care and track cost for patients regardless of where care is giving. Article links:
“Doc, Business Endorse “Medical Home”” Health Data Management
http://www.healthdatamanagement.com/html/newsstory.cfm?articleId=15148
6. Heritage Lectures 4/10/2007 by Senator Tom Coburn, M.D.
Competition: A Prescription for Health Care Transformation
www.heritage.org/Research/HealthCare/hl1030.cfm
Talking Points:
  a. America is going to have either a government-run health care system in which politicians and bureaucrats make the key decisions or a consumer-driven system in which key decisions are made by individuals and families.
  b. Physician and Senator Tom Coburn has introduced the Universal Health Care Choice and Access Act (S 1019) to allow consumers to make their own health care decisions.
  c. Among the bill’s provisions is prevention education to increase wellness and reduce health care cost. It contains a radical change to the tax code: a health care tax credit for all Americans and the ability for everyone to purchase health insurance from any qualified company in the country.
  d. Competition is critically important in healthcare as in every other facet of the economy. The bill allows a transparent health insurance industry to create programs that are best for individuals.
7. A coalition of more than 100 of the nation’s largest employers proposed a new employee benefit system in which workers would receive health care coverage and retirement plans through competing regional third-party benefit administrators.
Source:  Health Advisory Dailey Briefing, June 13, 2007

Infection Control

XDR TB
By now, everyone has heard the story about the man with XDR TB, a very virulent strain of TB, who flew around the world, eluding both health care organizations, customs agents and government officials as he made his sojourn.  The concern came from the fact, that although the form of TB this man carried was not considered to be highly contagious, being in close and closed proximity to other travelers who were not aware of this man’s condition put others at potential risk.  This situation also brought up more global concerns, such as the ability of our nation to truly deal effectively with homeland security, as well as the moral and ethical issues of whether any individual has the right to knowingly put others in danger due to a contagious disease they might have.  This situation mirrors one discussed in earlier reports, in which another man has been essentially incarcerated in an Arizona hospital due to his having this strain of TB.

As a nation and also as a world community, we need to determine humane and effective ways to deal with these emerging health threats.  This strain of TB has a 50% mortality rate and is basically untreatable with antibiotics.   The only treatment that seems to have any effect is lobectomy, which harkens back to pre-antibiotic days as medicine tried to treat TB by utilizing sanitariums and the “rest” cure.  Hospitals may find themselves being in the position of treating patients under forced quarantine. There is an urgent need to discuss these issues, and implement a global plan to deal with them.    

Pediatrics and Resistant Organisms
Johns Hopkins has begun rigorously screening all children admitted to their pediatric intensive care unit for MRSA and VRE.  They had already been engaged doing the same for adults admitted to the adult ICU.  They screen the children weekly via swab cultures and bacterial growth cultures.  These results were compared with the more standard routine testing that had been done in the past, in which patients were tested only after they had symptoms such as skin rash, fever or pain.  It was discovered that surveillance was 54% more likely to identify carriers of MRSA, and 35% more likely to identify carriers of VRE.  The ability to identify child carriers of these resistant bacteria is very important, since children are more vulnerable to problem of antibiotic resistance and can actually take fewer FDA approved medications.  This study has also suggested that the percentage child carriers has increased fourfold for MRSA and doubled for VRE as compared to data from 5 years ago.

Scientific Discoveries regarding the Ability of Bacteria to Mutate
The ability of gram- negative bacteria to protect themselves via a sensory and gene regulation system named ProP/ProQ has been recognized previously.  Researchers at NIH have now discovered a survival mechanism in gram-negative bacteria that enables them to ward off antimicrobial peptides.  These are defense molecules that the body produces to kill bacteria.  This not only demonstrates the complex defense mechanisms that bacteria possess, but also engenders excitement in the scientific community, since drug development can focus on inactivating these mechanisms.

An article in the Wall Street Journal recounted the story of a young man called Patient X who was admitted to a New York hospital in 2000 with a Staphylococcus aureus infection as well as a congenital heart problem.  The Staph aureus was susceptible to antibiotics initially, but during the course of antibiotic treatment, the patient got sicker, and the bacteria quickly mutated to become resistant to four antibiotics.  After a 12 week hospital stay, the patient died.  This hospital sent all Patient X’s blood cultures to Rockefeller University for study.  The scientists have been able to identify the genetic changes that the bacteria went through over the course of the patient’s treatment.  Over the 12 week period, the bacteria underwent 35 mutations, which altered a molecular sensor of production of a protein.  Each of these mutations made the bacteria more resistant to the antibiotics being used in treatment.  Development and evolution of bacterial resistance to antibiotics can occur over a week, as the weaker bacterial cells are killed by the antibiotic and the stronger more resistant cells are selected out, enabling them to pass their genetic mutations to future bacterial generations.

A seven-fold increase in Chicago’s Cook County hospital system’s incidence of CA-MRSA (community acquired MRSA) has been reported in the May 28th issue of Archives of Internal Medicine. Risk factors for CA-MRSA include prison time, exposure while playing certain sports, tattooing, poor hygiene, overcrowded housing, and IV drug use. These infections appeared not in place of but in addition to the incidence of MSSA (Methicillin susceptible staph aureus) in the same community.
 
Sources:
Altman, Lawrence K.  “Agent at Border, Aware, Let Man in with TB”.  New York Times; 6/1/07.
“CDC Update:  XDR TB Public Health Investigation”.  HPN Daily Update; 6/4/07
“Community-Associated Staph Infections Involving Antibiotic-Resistant Bacteria Increase”.  ICT;
5/29/07
Finn, Peter.  “Virulent New Strain of TB Raising Fears of Pandemic”.  Washingtonpost.com; 5/3/07
Hotz, Robert Lee.  “Evolution at Work:  Watching Bacteria Grow Drug Resistance”.  Wall Street
 Journal Online; 6/8/07
“Johns Hopkins Begins Aggressive Screening for “Superbuds” in Children”.  HPN Daily Update;
 5/20/07
“Newly Found Sensing System Enables Certain Bacteria to Resist Human Immune Defense”.
ICT; 6/12/07.
Schwartz, John.  “Tangle of Conflicting Accounts in TB Patient’s Odyssey”.  New York Times;
6/2/07.

Quality / Medication Errors / Safety Issues

U.S. Hospital Errors Continue to Rise
http://www.nlm.nih.gov/medlineplus/news/fullstory_47383.html
Patient safety errors in U.S. hospitals increased by 3% overall from 2003 to 2005. The error gap between the nation’s best and worse-performing hospitals remains wide. (4/2/2007)

A study,  “Healthgrades Patient Safety in America Hospital Study”, examined over 40 million Medicare hospitalization records of almost 5,000 hospitals between 2003-2005.
• There were 1.16 million patient safety incidents among Medicare patients (incidence rate of 2.86%)
• There were 247,662 potentially preventable deaths in U.S. Hospitals. Medicare patients involved in one or more safety error had a 25% chance of dying.
• Ten of 16 types of patient-safety incidents increased during these 3 years by an average of almost 12%. Post-Operative sepsis (34.3%), post operative respiratory failure (18.7%), selected infections due to medical care (12.2%)
• If all hospitals had performed at the same levels as the top-rated hospitals, about 206,286 patient safety incidents and 34,393 Medicare patient deaths could have been avoided, resulting in $1.74 billion in savings.

Medication Errors common in U.S. kids with cancer
 http://www.nim.nih.gov/medlineplus/news/fullstory_49699.html
5/25/2007 – Medication error data was collected in a national database from 1999-2004. A total of 829,492 errors were looked at that were reported in 29,802 pediatric patients. Findings show that children with cancer often get the wrong dose of chemotherapy or are given the drug at the wrong time. Many children require treatment because of the errors.

Chemotherapy has significantly helped boost children’s cancer survival rates, but the drugs are toxic and tricky to prescribe.

Recommendation in this article – drug makers, hospitals and doctors could come up with universal dosing standards that would simplify the task for health workers, who increasingly must combine several chemo drugs over a period of several days.

The AHRQ Quality Indicators in 2007 – newsletter
http://qualityindicators.ahrq.gov/newsletter/2007-February-AHRQ-QI-Newsletter.htm

Patient Safety Indicators Overview
http://qualityindicators.ahrq.gov/psi_overview.htm
The Agency for Healthcare Research and Quality (AHRQ) Quality Indicators (QIs) measure health care quality by using readily available hospital inpatient administrative data. The Patient Safety Indicators are a tool to help identify potential adverse events occurring during hospitalization. PSIs were developed after a comprehensive literature review, analysis of ICD-9-CM codes, review by a clinician panel, implementation of risk adjustment, and empirical analyses.
• Hospital-Level Patient Safety Indicators (20)
• Complications of anesthesia (PSI 1)
• Death in low mortality DRGs (PSI 2)
• Decubitus ulcer (PSI 3)
• Failure to rescue (PSI 4)
• Foreign body left in during procedure (PSI 5)
• Latrogenic pneumothorax (PSI 6)
• Selected infections due to medical care (PSI 7)
• Postoperative hip fracture (PSI 8)
• Postoperative hemorrhage or hematoma (PSI 9)
• Postoperative physiologic and metabolic derangements (PSI 10)
• Postoperative respiratory failure (PSI 11)
• Postoperative pulmonary embolism or deep vein thrombosis (PSI 12)
• Postoperative sepsis (PSI 13)
• Postoperative wound dehiscence in abdominopelvic surgical patients (PSI 14)
• Accidental puncture and laceration (PSI 15)
• Transfusion reaction (PSI 16)
• Birth trauma – injury to neonate (PSI 17)
• Obstetric trauma – vaginal delivery with instrument (PSI 18)
• Obstetric trauma – vaginal delivery without instrument (PSI 19)
• Obstetric trauma – caesarean delivery (PSI 20)

Ethics/ Non-Pharmaceutical Vendor Conduct

The Miami-Dade County Commission on Ethics and Public Trust issued its report, concluding that an ethics complaint was justified. Noting that sales to Jackson Memorial of St. Jude’s pacemakers and defibrillators climbed from $598,000 in 2004 to more than $2.5 million in the first 10 months of 2005, the report’s authors note that “[t]he primary beneficiary of this windfall is arguably Monica Rodriguez, Dr. Interian’s acknowledged romantic interest.” They estimate that Rodriguez earned more than $100,000 in commissions for her sales to Interian’s department at Jackson Memorial, and “undoubtedly tens of thousands in additional commissions” from sales to other hospitals where Interian practiced. “Industry experts and internal analysts at [Jackson Memorial] and [University of Miami] are at a loss to find any explanation for St. Jude’s sales gains – short of conflicted and/or exploitive behavior on Interian’s part.”
Though Interian remains a faculty member in good standing at the University of Miami medical school, the organization reports that it has tightened its conflict-of-interest policies to include anyone who has a personal relationship with a vendor.
From the Independent Medical Distributors Association

Disaster Preparedness & Surge Capacity – Their Associate Costs

The Disaster Preparedness Manual for Healthcare Materials Management Professionals, is now available to AHRMM members.  In an email I received from the Author, Mr. James Rush, he reminded me of a Grant program under the Department of Health and Human Services, called the National Bioterrorism Hospital Preparedness Program, it gives Public Health departments money to fund civilian hospitals efforts to build their response systems.  I need to look more into this grant program and report on it.
Also, under the Department of Health and Human Services - Agency for Healthcare Research and Quality (AHRQ), they conducted a series of webinar’s in 2003 specifically speaking to Surge planning in hospital settings, but they focused more on a Regional approach and Mutual Aid agreements.  Their premise being that in the majority of Disaster/Emergency Response scenarios, that a single hospital or healthcare site will not be the only responders and that other facilities in the area will also receive either casualties or be called on for use of their assets.

~ Bioterrorism and Health System Preparedness, Issue Brief No. 3 - Optimizing Surge Capacity: Hospital Assessment and Planning http://www.ahrq.gov/news/ulp/btbriefs/btbrief3.htm
~ Bioterrorism and Health System Preparedness, Issue Brief No. 4 - Optimizing Surge Capacity: Regional Efforts in Bioterrorism Readiness http://www.ahrq.gov/news/ulp/btbriefs/btbrief4.htm

UPN Issues / Data Standards Issues

The Education and Enablement Committee elected co-chairs, and the co-chairs of all three sub-committees are scheduled to meet this month. The subcommittees meet bi-monthly. The Oversight Committee of the HSCSC will meet in Chicago on July 9th. Meanwhile, Australia, Canada, and France have chosen to move forward with the GLN and GDSN (using 1SYNC – a subsidiary of GS1).