The U.S. Department of Justice announced yesterday that it has finalized an agreement with Medco Health Solutions, among others, to settle the False Claims Act lawsuits pending against Medco in the federal district court in Philadelphia, PA. Under the settlement agreement, which was first announced in May 2006, Medco will pay the Government and the qui tam relators who initially brought the lawsuits over $155 million. Medco also is entering in a corporate compliance agreement, and it has agreed to treat the settlement and related payments as “unallowable costs” for purposes of its government contract business with Medicare, Medicaid, TRICARE, and the FEHB Program. The settlement documents are available here. This settlement brings to a close litigation that raged for several years.

On Friday, October 20, the Healthcare Information Technology Standards Panel met again to consider amendments to its first three sets of interoperability standards. Modern Healthcare.com published a full report on the meeting today. HHS’s American Health Information Community (AHIC) will consider the standards at its October 31 meeting.

Modern Healthcare explains that

In its personal health-records [PHR] use case, AHIC proposes that PHR systems would be more useful and attractive to patients if they could be linked electronically to data sources so that a patient’s medication history and basic health and demographic information could be loaded into the PHR with little patient effort.

The PHR related interoperability standards therefore concern an electronic patient registration (or medical summary) and an electronic medication history. Modern Healthcare reports that

Considerable controversy arose last month over a report of the technical committee working on the PHR specification to create a patient’s medical summary. The committee recommended adopting the Exchange of Personal Health Record Content (XPHR) as an interim specification even though the specification is still under development by Health Level 7, the Ann Arbor, Mich.-based standards development organization. The recommendation drew cries of foul from supporters of the competing Continuity of Care Record, which has been developed, balloted and is in use by providers and IT vendors. The CCR was developed by ANSI-accredited standards development organization, ASTM International.

HITSP settled the controversy by postponing for six months a decision on which standard to endorse for the PHR use case while expressing a preference for using the Continuity of Care Document, itself a compromise between HL7 and ASTM. The CCD, which incorporates the CCR, is expected to be balloted sometime early next year. Thus, the specification for the PHR that was sent to the AHIC Friday was not deemed to be a standard ready for testing, as were the other specifications, but rather a “work in progress.”

Another area drawing critical comment was a decision by HITSP to use the HL7 version 2.5 communication standard for transmitting lab data and results to an EHR rather than the EHR-Lab Interoperability and Connectivity Standards, or ELINCS, a project of the California Healthcare Foundation.

FEHB Plan carriers will be obligated to adopt these interoperability standards in their new and upgraded health information technology under a 2008 contract amendment that OPM will adopt pursuant to the President’s August 22, 2006, Executive Order.

On a related note, the Certification Commission for Healthcare Information Technology (CCHIT), which like HITSP operates under an HHS contract, certified several additional ambulatory HIT products today, including several electronic health record products.

The Surgical Care Improvement Project released a Surgical Safety Tip Sheet for patients and family members today that received kudos from HHS Secretary Mike Leavitt, among others.

Michelle Singletary wrote an interesting piece in today’s Washington Post about tools that are available on the internet to health care consumers, such as Health Grades and my Family Health Budget. Many of these tools are made available by health plans to their participants.

Robert E. Moffitt, the director of the Center for Health Policy Studies at the Heritage Foundation, praised the FEHB Program’s competitive model in an op-ed published today in the Washington Times.

All doctors (and Katie Couric) agree on the value of colonoscopy as a medical screening tool for people over 50 . In fact the Columbia University Department of Surgery notes that

“By screening people every five to 10 years, we think we can prevent most cancer formation,” says gastroenterologist Christine L. Frissora, M.D. In fact, having just one colonoscopy decreases your lifetime risk of dying from colorectal cancer by 68 percent.

The Washington Times reports today about a study published in the medical journal Radiology finding that virtual colonoscopy which uses three-dimensional computed tomography produces accurate diagnoses as compared to invasive, optical colonoscopy. The “research found that only 6 percent of the patients who underwent a virtual colonoscopy required a subsequent conventional colonoscopy.” The article reports two especially interesting facts:

In addition, the [virtual] procedure has yielded surprise benefits. It has picked up “clinically important extracolonic findings,” according to a study last year at the San Francisco VA Medical Center. Virtual colonoscopy revealed kidney cancers, abdominal aneurysms and other serious conditions in 45 out of 500 patients who underwent the procedure.

Meanwhile, the American College of Gastroenterology has not yet given its blanket approval of virtual colonoscopy for routine screening. But the Maryland-based group yesterday pronounced capsule colonoscopy — in which the patient swallows a jelly bean-sized video camera that records thousands of images — a “promising new tool for colon cancer screening.” The group will release complete research findings on Monday.

Earlier this month in Tampa, Florida, Walmart and Sam’s Club pharmacies began selling a thirty day supply of about 300 types of generic drugs for $4.00 whether or not the patient is insured. Walmart indicated at the time that it planned to expand the program to all of Florida at the end of the year and beyond Florida in 2007. Walmart almost immediately changed gears and opened the program to all of Florida. Today it announced the immediate expansion of the program to 14 additional states: Alaska, Arizona, Arkansas, Delaware, Illinois, Indiana, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, Texas and Vermont.

My colleague, Theresa Defino, has called to my attention this very informative HHS website on healthcare transparency. I’m not sure how long the site’s been up on the web, but it is chock full of healthcare pricing and quality transparency information.

The Journal of the American Medical Association and the U.S. Centers for Disease Control published a report this week estimating that as many as 700,000 Americans wind up in the emergency room every year due to adverse reactions produced by combining prescription drugs with over the counter drugs or herbal supplements. Most of the affect population is over 65. The projection is based on a surveillance project on outpatient drug safety that started in 2004.

The Chicago Tribune reports that

The study’s authors said that in 2004, 82 percent of the U.S. population reported using at least one prescription drug, over-the-counter medication or dietary supplement, and 30 percent reported using five or more drugs. More effort must be made to prevent adverse events, the researchers said.

The study’s database included 63 nationally representative hospitals that reported 21,298 adverse drug reactions among American adults and children treated in emergency rooms during the two-year period.

On September 15, I blogged about two drugs that Merck and Novartis were developing to treat type 2 diabetes. On October 17, the Food and Drug Administration approved the Merck drug Januvia (sitagliptin phosphate), a once a day pill also known as a DPP-4 inhibitor that helps the body lower elevated blood sugar levels. Mayoclinic.com explains that

Controlling your blood sugar is essential to avoiding long-term complications of type 2 diabetes. If you’re struggling to control your blood sugar with diet, exercise and traditional diabetes medications, Januvia may provide a welcome alternative. Ask your doctor if Januvia would be an appropriate addition to your current treatment plan, or if the drug could be used in place of the medications you’re currently taking.

A survey of doctors revealed that physicians intend to prescribe the new drug in lieu of an Eli Lilly drug Byetta that was launched in June 2005. Forbes.com notes that “Merck is expected to charge $4.86 for the pills, which are taken once-a-day [or $146 per month]. Older diabetes drugs can cost as little as 50 cents a day, according to published reports.” Drug manufacturer CFOs love this type of drug because the large population suffering from this disease would take the pills for a long time.