Validating Autologin....

Issues & Legislative Committee Reports

November 8, 2007

TJC / GPO Oversight Committee

The Joint Commission
CDC has funded a JC study of how rapid tests for influenza are implemented in outpatient medical settings, including acute care hospital emergency rooms.  JC will be looking at the broad scope of rapid test use in 5,000 facilities of the next 3 years.

JC has announced another new certification program--this one for Chronic Obstructive Pulmonary Disease (COPD), the fourth leading cause of death in America.  It was developed jointly with the American Lung Association.

GPO Oversight Committee
The HHS Office of Inspector General established a new safe harbor protection under the federal anti-kickback law for federally funded community health centers that provide care to underserved populations.  It's intent is an easing of the physician referral restrictions.

The Fort Worth Weekly reported this month on the recently unsealed qui tam (Federal False Claims Act) action against Novation, the nation’s largest GPO. The article highlights the case of Cynthia Fitzgerald, a whistleblower and realtor in the action against Novation. She contends that Novation illegally received additional payments and kickbacks from vendors to contract with the GPO. Fitzgerald was eventually terminated from bringing these claims to her superiors. The article also provides a brief overview of the GPO history.

Gainsharing Agreements

From an October 2007 article by Lauren Uzdienski titled Questions and Controversies Still Loom Over Gainsharing, a 2006 survey of 95 orthopedists, published in Journal of Bone and Joint Surgery in September, 61% of respondents said they believed that gainsharing programs were an effective way to align hospitals and physicians to decrease health-care expenses. However, further survey questions revealed that physicians were at times unsure about what does and what does not constitute gainsharing.

The 2006 survey showed only 15% of the physicians believed gainsharing compromised the quality of patient care. Additionally, physicians were split over whether a they should be required to disclose participation in a gainsharing agreement to patients.  There was also inconsistency in what was believed to constitute gainsharing. In the following scenarios, the article pointed out the differences in opinions after Physicians responded to statements to indicate whether a case was or was not Gainsharing. These scenarios included:

According to this article, data coming out of existing agreements shows that not one physician has changed the vendor he or she used and in every situation, better pricing from all of vendors occurred.

Though only 23% of physicians surveyed said they were involved in a gainsharing program, 76% of physicians said they would participate if they had the opportunity.

Source:  http://www.healthpointcapital.com/research/2007/10/26/
questions_and_controversies_still_loom_over_gainsharing/

Consumer Driven Healthcare

Record Numbers go Abroad for Health
70,000 Britons will travel abroad this year for healthcare.
India is the most popular and the US is not on the list as a popular destination.
Source:  Daily Policy Digest 10/29/2007

Medical Tourism
500,000 Americans traveled in 2005 to receive medical care.
Most traveled to Mexico and Latin America but Americans were among the:
250,000 patients going to Singapore
500,000 patients going to India
1,000,000 patients going to Thailand

The main reason Americans travel is cost. Some examples are:
Knee replacement          Singapore – $18,000      India – $12,000        US – $30,000
Cardiac Surgery            Singapore – $ 4,000      US – $30,000
Nose Reconstruction     India – $   850               US – $ 4,500

Link to the study:  http://www.ncpa.org/pub/st/st304/st304.pdf 
Source: Daily Policy Digest 11/1/2007

Singapore: Medical Travel and Consumer Driven Health Care
4% of the 10 million visitors to Singapore were “medical traveler.”
The main reasons for Americans to go to Singapore are cost and quality.  Costs are low, facilities are JCI accredited and physicians are trained in the US.  According to a WHO 2000 report Singapore’s healthcare system was the best in Asia.  They are doing a coordinated effort between the government and the facilities to market to medical traveler to give them the critical mass needed to support their investments in healthcare equipment and technology.
Source:  AARP.Org  6/2007

Mass. Web Site to Promote Consumer-Driven Health Care
The non-profit Partnership for Healthcare Excellence has developed the www.partnershipforhealthcare.org site with links for various sources of care and cost data.
Source:  Boston Business Journal  10/25/2007

Consumer-Driven Plans Gaining Traction Among Employer
This article describes High-deductible health care plans and Health savings accounts and how they work to control an employers health care cost.  It talks about how the employer needs to communicate the plan and its benefits to the employees to gain buy in.
Source:  Nashville Business Journal 10/5/2007

Consumer-Driven Healthcare:  Information, Incentives, Enrollment and Implications for National Health Expenditures
This is and in-depth article that talks about how CDHC could drive need, utilization, and price to decrease total healthcare expenditures. I am sending the article for distribution.
Source:  Business Economics  4/2007

Consumer Driven Healthcare

Ethics / Pharmaceutical and Vendor Gifts

Pharmaceutical Industry Influence on Doctors
Medicine and the Drug Industry, a Morality Tale, by Abigail Zuger, M.D.  Here's an excerpt:
Less familiar may be some of industry’s other friendly overtures: the lavish junkets and cash rewards for some “high-prescribing” doctors; the subtle manipulations of research data; the way-too-generous financing of postgraduate medical education; the very cozy relationship with the Food and Drug Administration and its physician consultants; and a casually Orwellian interference with the average physician’s prescription pad.

A drug salesman recalls for Dr. Brody the time his company asked a local doctor to evaluate various sales presentations for a particular drug: “He’d been selected because our data showed that he was a relatively low prescriber. ...Basically, the company was willing to bet $500 or $750 that if he heard the same drug pitch all day, by the end of the day he’d be so brainwashed that he could not possibly prescribe any other drug but ours.”

All this mutual back-scratching would be fine if patients’ interests were indeed being served. But ample data indicates quite the reverse. Patients, after all, are the ones who pay for expensive drugs when cheaper would do as well, and the ones who swallow dangerous drugs nudged to market by their manufacturers.
Source:  New York Times

FDA’s oversight of DTC advertising.
The report found that the FDA reviews only a very small portion of the DTC materials it receives and cannot ensure that it is identifying the materials it considers to be highest priority. Upon release of the findings, Senator Kohl sent a letter to President Bush, urging him to include additional funding for the FDA in his FY 2008 budget proposal to establish a system to effectively review and regulate DTC advertising of prescription drugs.
Source:  http://aging.senate.gov/issues/healthcare/advertising.cfm

In head-to-head trials of two drugs, the one deemed better appears to depend largely on who is funding the study, according to an analysis of nearly 200 statin-drug comparisons carried out between 1999 and 2005.

UCSF researchers examined 192 published results of trials comparing one cholesterol-lowering statin drug to another, or to a non-statin drug.

Their findings found that two links stood out. If the reported results favored the test drug, the trial was about 20 times more likely to be funded by the maker of the statin rather than the comparison drug company. Even more striking, they say, if the conclusions or interpretation of the drug trial - which reflect the impressions of the trial investigators -- favored the test drug, the trial was about 35 times more likely to be funded by the maker of that drug rather than the comparison drug.

The results of the new analysis are reported in the online edition of the journal "PLos Medicine."

"Many people are concerned about the growing proportion of drug trials funded by the drug's manufacturers," says Lisa Bero, PhD, UCSF professor of clinical pharmacy and health policy studies. "Results of drug trials affect what drugs are covered by medical plans, and so what drugs physicians will prescribe. If drug trial outcomes are largely determined by who pays for the trial, we don't really know what the best drug is." Bero is senior author on the PLoS paper.

The UCSF study examined the links between reported outcomes of the statin trials and many factors, including study design, sample size, thoroughness and type of analysis, as well as funding source. They examined only published randomized controlled trials. The trials involved seven different statins overall, all studied in head-to-head drug comparisons.

The analysis found that about half of the trials were funded by industry, and about a third did not disclose any funding source. Among those declaring industry funding, about one fifth explained the role of the sponsor, such as data analysis, or writing and preparing the manuscript. Trials with no disclosed funding sources were less likely to have conclusions favoring the test drug, compared to trials with industry funding, the researchers report.

The researchers note that a number of factors can result in the drug trial results favoring the trial drug's sponsor. Drug companies could selectively fund trials on drugs that are likely to produce a statistically significant result, the researchers explain. This can be accomplished, they say, by selecting non-equivalent doses of drugs for testing. Also, sponsors may choose not to report results that don't favor the drugs they sell. Or, they may report positive results in more than one journal, skewing the number of positive articles about their drug.

In addition, almost half of the trials lacked adequate blinding - assuring that study scientists don't know which drug the patients were taking until the end of the trial. Blinding is considered of paramount importance in clinical trials. The researchers found that those studies with adequate blinding were less likely to report results favoring the test drug. This finding was independent of who funded the study - in other words, funding source was a stronger predictor of outcome than blinding, but both had independent effects on outcome.

The most important weakness found in most of the trials was a lack of clinical measures of outcome, such as heart attacks or mortality -- considered better indicators in trial design than less direct measures such as lipid levels.

"The lack of true clinical outcome measures in these direct head-to-head comparisons of drugs is disappointing because the studies don't give us the best information we need to choose one statin over another," Bero says.

The analysis is one of the first large studies examining the influence of funding source on the outcomes of head-to-head drug comparisons, rather than comparing the effectiveness of one statin with no drug at all. The market for statins is competitive, so it is important to have valid information to choose one statin versus another, Bero explained. For policy makers, the relevant choice is not to select a statin versus a placebo, but to select one statin compared to another.

The study also differed from most other assessments of influences on drug trials by examining 11 different factors, and how they may interact to affect trial results. Most previous studies examined the link of results to one factor alone, such as funding source. But this analysis adjusted for "confounders" - study aspects that can influence the results, such as study design, including randomization, blinding, sample size, even choice of comparison drug in the study.

Inclusion of the confounders still pointed to industry sponsorship as the most influential factor related to positive results and conclusions.

The study examined trials by all funding sources, as well as a subset of studies that were only industry funded. Favorable results and conclusions were associated not so much with industry sponsorship, but with the specific company that funded the study, Bero points out.

"The data available on choosing between statins based on head-to-head drug comparisons appears to be influenced by financial conflicts of interest," Bero concludes. "So decision makers -- those choosing drugs for a formulary or insurance plan -- should be skeptical about these kinds of trials. We need to know if a newer, more expensive drug is really better compared to older, less expensive drugs."

Source: 
http://www.medicalnewstoday.com/articles/73180.php 
http://pub.ucsf.edu/newsservices/releases/200705311/

Influence of drug company authorship and sponsorship on drug trial outcomes
Tongeji Tungaraza, MRCPsych and Rob Poole, FRCPsych
North East Wales Trust, UK

Declaration of interest T.T. has accepted sponsorship to attend conferences from Janssen-Cilag and Eli Lilly. R.P. has accepted speakers' fees from Lundbeck, Eli Lilly and Pfizer; he has also accepted sponsorship to attend conferences from Wyeth, AstraZeneca and Eli Lilly. No funding was obtained for the present study.

Studies of drug treatments are more likely to report favorable outcomes when they are funded by the pharmaceutical industry. We compared drug trials reported in three major psychiatric journals to investigate these influences. Independent studies were more likely to report negative findings than industry-funded studies. However, the involvement of a drug company employee had a much greater effect on study outcome than financial sponsorship alone.
Source:  The British Journal of Psychiatry (2007) 191: 82-83. doi: 10.1192/bjp.bp.106.024547
http://bjp.rcpsych.org/cgi/content/abstract/191/1/82 
http://www.nofreelunch.org/whatsnew.htm

Quality / Medication Errors / Safety Issues

Safety Briefs
FDA cough and cold panel touches on medication errors
A number of medication error-related issues were discussed when a joint meeting of FDA’s Nonprescription Drug Advisory Committee and Pediatric Advisory Committee met in mid-October 2007 to discuss pediatric cough and cold products. During the meeting, committee members and a representative from FDA’s Division of Medication Errors and Technical Support (DMETS) discussed error-related issues with OTC cough and cold medication for children less than 6 years of age, including situation in which well-known brand names have been used for an extended line of products, even though the products may not contain the original ingredients. The merits of using mL as the standard dosing unit for these products were also discussed. Measuring in teaspoons, tablespoons and droppers have proven to be error prone since volumes in these household devices are not standardized. The committee has recommended standardizing oral liquid dozing devices contained with products. Errors have occurred when dose cups intended for certain products were used with another product who ingredients concentration and dosing parameters didn’t match. The committee also requested that manufacturers undertake studies to evaluate how well labels are understood by consumers and what factors enhance comprehension and safe use. FDA will take the committee’s suggestions under consideration and draft a proposed rule to change drug monographs for cough and cold products, including recommendations to reduce the risk of medication errors. The publication will have a comment period and then the FDA will publish a final rule. The impact of these decisions on product availability and packaging will be determined by how closely FDA follows its advisory committee’s recommendations and feedback received during the comment period. The process could take several years.

Unintended consequences of high-alert stickers
Some hospital and pharmacies are labeling high-alert medications with special “high-alert drug” stickers sold by various vendors. This practice might be detrimental to your safety efforts if you apply these stickers to too many drugs or if you forget to apply them to a targeted drug.  While the failure to place a required warning label on a targeted product is a proximate cause of some errors, sometimes “warnings” can be too numerous to be effective. Placing high-alert stickers on all or most high-alert drugs may be similarly diluting your efforts to make items stand out. ISMP encourages selective use of auxiliary labels to call attention to very specific product problems. Once a drug has been designated to receive an auxiliary label, a process should be established to ensure that the label is applied consistently.
Source:  ISMP Medication Safety Alert – November 1, 2007, Vol. 12, Issue 22

Special announcements
Draft ADC guidelines – ISMP in 2007 held a national forum with pharmacists, nurses and vendors to develop the first set of consensus-driven safe practices for automated dispensing cabinets. ISMP is seeking comments on the guidelines which can be found at:  www.ismp.org/Tools/guidelines/default.asp.

ISMP ADC Symposium – An ISMP satellite symposium on ADCs (automated dispensing cabinets) will be held December 2, 1:00 p.m. – 3:00 p.m. during the ASHP Midyear clinical Meeting. The speakers will address common errors associated with ADC use and safe practice recommendations, including formulary management, restocking procedures, ADC system overrides and more.  www.ismp.org/survey/Reg200712.asp

Med-E.R.R.S teleconference – MED-E.R.R.S. will be sponsoring a teleconference for the pharmaceutical industry “Spotlight on Medication Safety: Designing Safe Packaging and Labels” to be held November 14, 1:30 – 3:00 p.m. ET.www.mederrs.com/teleconferences/

Disaster Preparedness & Surge Capacity – Their Associate Costs

National Response Framework
The NRF is still open for review and feedback, but it seems to be getting hit with a lot of criticism.

Earlier, in the Congressional Quarterly, Congressional members have also blasted the lack of support of the Post-Katrina Reform Act that the NRF is supposed to support.

On 26 October, Continuity Central reported that the International Agency of Emergency Managers presented feedback to FEMA regarding the National Response Framework.  Their input included:
- DHS should ensure that the NRF is consistent with the Post-Katrina Reform Act, particularly the authority and responsibilities.
- Local plans should be made according to hazard identification and risk analyses (HIRAs).
- The NRF lists 15 scenarios; additional planning would incorporate only those scenarios that actually apply to the local jurisdiction. (Federal planning, of course, should maintain a disciplined focus on all of the 15 scenarios.)
- State and local emergency managers should be notified when ESF/playbook changes occur.

A decision should be made on whether tribal nations will be treated as a local or state entity in the disaster process.

Prime Newswire reported on 30 Oct 2007, http://www.primenewswire.com/newsroom/news.html?d=129997, about the US Health Systems inability to respond to Disasters or Emergencies as a whole.  The article touches on issues like Authority to respond at the Federal level; as well as Breakdowns of communication at the local response level

The article calls on local/regional authorities to collaborate with regards to shared areas of responsibilities; as well as collaboration between the public and private sectors to support and help fund actions that support disaster preparedness and response at all levels.

Maj Hale then closed his report following a discussion point brought up by Jeff Wagner, “customers that turn-in outdated items, not a lot, but a couple of items that would, in an emergency situation could have been consumed rather quickly”.  Bill Meyer then added that in facilities around him, there may be a very parochial stance to brooch the subject of material readiness with providers and clinicians.  Bill suggested that if a higher level directive from the Federal government or the Joint Commission establishing collaboration between Providers and their Material Managers would help get discussion started and planning continued support to occur.

FDA Reviews

Current Critical Priority Medical Device Alerts

  1. Nx Stage Cartridge express Hemodialysis Cartridge: Dialysate may leak during treatment.
  2. Ortho-Clinical Diagnostics-Reagent Red Blood Cells Resolve Panel C Kits May demonstrate unexpected reactivity with untreated Cell 6
  3. Medtronic- Sprint Fidelis Leads: Conductor may fracture Models 6949 and 6949 Isolate and discontinue us per Medtronic’s