The Southern Nevada Health District (SNHD) recently notified 40,000 people that the unsafe syringe handling practices of the Endoscopy Center of Southern Nevada may have infected them with bloodborne pathogens. The Health District advised these people to undergo testing for Hepatitis B and C and HIV.

Since the beginning of the investigation in January 2008, the U.S. Centers for Disease Control Since beginning the investigation, CDC and SNHD “have identified a total of six cases of HCV infection among patients who had undergone procedures at the clinic in the 35–90 days prior to onset of symptoms. These patients did not have other risks for HCV infection.”

The Las Vegas Sun reported on the “assembly line” colonoscopy procedures at the clinic:

The Endoscopy Center of Southern Nevada opened in March 2004 in a medical building at 700 Shadow Lane, between two of the city’s largest hospitals — and across the street from the offices of the Southern Nevada Health District, which launched its surprise inspections of the facility in January. The business complements Desai’s Gastroenterology Center of Nevada, which has six valley locations. Although other doctors worked at the high-volume facility, it was Desai’s domain. Appointments were frequently double-booked, leading to two-hour waits in a standing-room-only waiting room, said a nurse who worked there in 2007. In assembly-line fashion, patients were hurried among nurses who would admit them, start an IV in their arm, take them to the room for the procedure, and then walk them to a recovery area before sending them out the door. “He would always say, ‘Time is money,’ ” the nurse said of Desai. “The faster we would go, the happier he was.” The flow of patients sounds impossibly fast, said Phyllis McGregor, a nurse who for 20 years directed the gastroenterology department at Centinela Hospital Medical Center in Inglewood, Calif. She ran three rooms where a total of 30 procedures a day were done, at the most. Desai was doing 60 procedures in two rooms — a pace that McGregor said compromised patient safety.

The Las Vegas Review Journal features a hot topics page on the sad story.

The Endoscopy Center has been shut down by the City of Las Vegas except for administrative activities. The owner has agreed to stop practicing medicine at least until the investigation is completed. Snap inspections by Nevada health authorities and the CDC have disclosed unsafe procedures at other ambulatory surgicial centers in the state. A local columnist opined that “no matter how the Endoscopy Center of Southern Nevada saga plays out, it’s going to be a long time before the Las Vegas community gets back to feeling good about health care here.”

• NY Attorney General Andrew Cuomo expanded his investigation of the Ingenix usual reasonable and customary fee database last week by issuing new subpoenas to Aetna, Cigna, United Healthcare (which owns Ingenix), Wellpoint and other major managed care companies. Modern Healthcare.com reports that
  

  Cuomo is seeking all e-mail correspondence involving the companies’ CEOs, chief operating officers, chief fiscal officers, presidents and employees supervising claims. He also wants any records that might question the accuracy of reimbursements that he says are too low.

  Cuomo also is interested in taking testimony from the CEOs of these companies. The Dow Jones newswires reported on Thursday that “Empire Blue Cross Blue Shield said it hasn’t found any evidence that its use of data from UnitedHealth Group Inc.’s (UNH) Ingenix was defective as it cooperates with the New York Attorney General’s office.” The Wall Street Journal reports today that “UnitedHealth spokesman Tyler Mason says, “We are in the midst of talks with the attorney general’s office, and we will continue to fully cooperate.” The managed care trade association AHIP “decried” the expansion of the investigation according to Modern Healthcare.com
  

• There are two Average Wholesale Price class actions pending in the U.S. District Court for the District of Massachusetts — one is an action against several prescription drug manufacturers who allegedly improperly inflated the AWP and the other is an action against First Databank and McKesson who allegedly conspired to inflate an AWP factor. On Friday a settlement in the first case was announced by plaintiffs’ counsel:
  

  Today eleven major pharmaceutical companies, including Abbott Laboratories (NYSE: ABT) and Watson Pharmaceuticals (NYSE: WPI), agreed to a $125 million nationwide settlement in the average wholesale price (AWP) litigation filed in 2002 by consumers and insurance companies, which claimed the defendants intentionally inflated reports of the average wholesale prices on certain prescription drugs. The defendants included in today’s settlement are Abbott Laboratories, Amgen Inc., Aventis Pharmaceuticals Inc., Hoechst Marion Roussel, Baxter Healthcare Corp., Baxter International Inc., Bayer Corporation, Dey, Inc., Fujisawa Healthcare, Inc., Fujisawa USA, Inc., Immunex Corporation, Pharmacia Corporation, Pharmacia & Upjohn LLC, Sicor, Inc., Gensia, Inc., Gensia Sicor Pharmaceuticals, Inc., Watson Pharmaceuticals, Inc., and ZLB Behring, L.L.C. Drugs covered in this settlement include Aranesp, Epogen, Neupogen, Neulasta, Anzemet, Ferrlecit and Infed. Two major defendants — AstraZeneca and Bristol-Myers Squib – not part of settlement.

  Plaintiffs’ counsel in the second action asked the Court last week to schedule a status conference at which the plaintiffs and First Databank will present a revised settlement agreement as directed by the Court at a January 22, 2008, hearing. The Court scheduled the hearing for March 19.

• Modern Healthcare.com reports that “The CMS is heading in the right direction on value-based purchasing, but it should not be used as a vehicle to reduce Medicare spending, hospital leaders said during a roundtable hosted by the Senate Finance Committee.”

• OPM submitted a short term disability program bill to Congress on Friday. According to OPM’s press release, “Under the proposal, participation would be voluntary and insurance premiums would be fully paid by the policy holder.” Thursday’s House Federal Workforce subcommittee hearing indicates that this proposal will not be well received on Capitol Hill. OPM’s Capitol Hill problems are illustrated in this Federal Times article about OPM’s legislative proposal to rehire more annuitants (S 2003 and HR 3579).

• The House Subcommitee on Federal Workforce, Postal Service, and the District of Columbia, which has responsibility for FEHB Program oversight, held a hearing today on a bill (HR 3799) introduced by Rep. Carolyn Maloney (D NY) that would provide federal employees with eight weeks of full pay and benefits for leave taken for the birth or adoption of a child. Subcommittee chairman Danny Davis (D Ill.) announced his support for the bill. He also stated that he is introducing a bill that would increase the maximum age for FEHB Program dependent coverage from 22 to 25.
• Yesterday, the House passed its version of the mental health parity bill (HR 1424) as anticipated. The vote was 268 to 148 with 47 Republicans supporting the bill and 3 Democrats opposed it. The legislation now moves to a conference committee. Interestingly, the House tagged onto this bill its genetic non-discrimination bill which has been bottled up in the Senate. The White House favors the Senate bill.

The Providence Journal reports that the U.S. House of Representatives will debate and vote on its mental health parity bill (H.R. 1424) on Wednesday of this week. The Senate passed its version of this legislation (S. 558) last year, and since then informal efforts have been underway to reconcile the two versions. (The House version is more expansive of the two; both are more expansive than the FEHB Program’s successful mental health parity initiative.) Formal reconciliation efforts will ensue once House passage occurs as is likely.

• The attorneys for First Databank and the class action plaintiffs in the Average Wholesale Price RICO case reported to the Court on Friday that they had reached in principle an alternate settlement proposal that will be submitted to the Court by March 5. You will recall that the Court on January 22 rejected the first proposal that would have provided no monetary relief to consumers or health plans harmed by the alleged jacking up of the AWP. The Court sent them back to the negotiating table. We likely will see their work product this week.

• The HIMSS mega-conference was held in Orlando last week. Modern Healthcare and Health IT News report on industry reaction to the Google and Microsoft electronic health information initiatives.

• Tomorrow is the first business day of the brave new world that CMS recently announced on its National Provider Identifier website:
  

  MARCH 1st IS A CRITICAL DATE! As of March 1, 2008: Medicare claims with both an NPI and a Medicare legacy number will continue to be rejected if the pair is not found on the Medicare NPI Crosswalk. Claims without an NPI in the primary provider field (i.e., the billing, pay-to, and rendering fields) will be rejected! Claims with only a Medicare legacy number in the primary provider field will be rejected!

  It would be advisable for health plans paying secondary to Medicare to take the same approach.

• These Washington Post and Chicago Tribune articles on the problems with the Chinese manufactured ingredients incorporated in Baxter’s Heparin product adds an interesting wrinkle to the prescription drug importation/reimportation debate.

OPM updated its strategic plan this week. Here are the new operational goals that relate to the Federal Employees Health Benefits Program:

• Establish a working group with OPM’s Office of the Inspector General and develop steps to strengthen the controls and oversight of the Federal Employee Health Benefits Program pharmacy benefits by July 1, 2008. (B-46)

• Develop and communicate clear documentation requirements for carrier compliance with health benefits related audit findings by August 1, 2008. (B-49)

While the strategic plan includes legislative initiatives such as a short term disability program, the Federal Times reports that

At a Feb. 29 press conference on her department’s priorities, [OPM Director Linda] Springer acknowledged that it will be tough to get any bills passed during the Bush administration’s final, lame-duck year.

• CMS actuaries released health care cost projections for the U.S. on Tuesday. Here are some tidbits:
  

  Through 2017, growth in health spending is expected to outpace that of GDP by an annual average of 1.9 percentage points. This projected differential in growth rates is smaller than the 2.7 percentage-point average difference experienced over the past 30 years, but wider than the average differential (0.3 percentage point) observed for 2004 through 2006.Hospital spending growth is expected to accelerate from 7.0 percent in 2006 to 7.5 percent in 2007, partly attributable to higher Medicaid payment rates.

  Hospital spending growth is then projected to decrease slightly though the rest of the projection period as the growth in demand for hospital services is expected to slow.

  Prescription drug spending growth is expected to slow to 6.7 percent in 2007 (from 8.5 percent in 2006), driven largely by slower drug price growth.For 2008 through 2017, prescription drug spending is projected to accelerate due in part to the projected leveling off of growth in the generic dispensing rate and evolving treatment guidelines that call for earlier introductions of pharmacotherapy.

• Kaiser Health Policy reports that Congress may take action in March on extending the Medicare Part B physician reimbursement fix, which currently expires on June 30.

• The New York Times reports on Aetna’s decision to continue reimbursing a “powerful anesthetic” when used on patients undergoing a colonoscopy. According to the article,
  

  Insurers have been split on whether to cover propofol for colonoscopies. Humana and WellPoint are among the large players that, like Aetna, have sought to curtail coverage while UnitedHealthcare, which has 26 million members, has advertised its intent to support propofol in all screenings. Medicare leaves the decision up to its local carriers, most of which have restrictive policies. Some doctors maintain that propofol helps them by keeping patients calmer during screenings than the traditional cocktails they administered of sedatives like Versed and tranquilizers like Valium. And, because it wears off sooner, patients can go home more quickly. (As a man over 50 that sounds good to me.)

• In health information technology news, Government HIT News is reporting that the federal government is building its own “mini” national health information network in order to jump start that critical process. The NHIN is the backbone that knits together the regional health information organizations or RHIOs.

• It’s a Senate tradition to annually read George Washington’s farewell address. The 2008 reading will take place tomorrow. We all should take the time to read it over.
• Earlier this month, we learned that the federal court in Boston wisely had rejected the proposed First Databank average wholesale price settlement at the January 22 fairness hearing. The judge allowed the parties two weeks to offer a revised settlement agreement. I have found no evidence that a revised settlement agreement has been submitted to the court.
• We also learned about a week ago that the New York attorney general warned United Healthcare of his intent to file a lawsuit against UHC and its Ingenix subsidiary over the usual reasonable and customary price database that many insurers use to price out-of-network claims. No lawsuit has been filed yet. Bloomberg reports that “UnitedHealth Group Inc., the largest U.S. health insurer, is poised to reach its forecasts of 13 percent profit growth this year and next, even after being accused of cheating customers by New York’s attorney general.”
• The Cleveland Clinic announced last week an electronic health records project with Google Health, which is similar to Microsoft’s Health Vault pilot. The health care providers evidently obtain HIPAA compliant authorizations from the participating patients so that Google and Microsoft can avoid HIPAA business associate coverage. Meanwhile, the New York Times reports today that privacy concerns are leading many to avoid DNA tests. A genetic non-discrimination law has been pending Senate floor action in Congress for months.
• The New York Times also included an interesting article on parent attitudes toward the Gardasil vaccine.

The AP reports that for the first time the biotechnology drug industry via its trade association, the Biotech Industry Association, signalled its willingess to accept a law that creates a pathway for generic versions of biological drugs. The AP article suggests however that it is unlikely that such a law will be enacted this year. The generic drug trade association, the Generic Pharmaceutical Association, is not rushing for a deal this year because it expects a more favorably disposed Congress next year.

On February 15, the Food and Drug Administration published a proposed rule providing prescription drug manufacturers with guidance on “Good Reprint Practices” which explain the difference between appropriate distribution of scholarly articles on off-label uses of prescription drugs and illegal marketing of off-label uses. An AP report explains that “Off-label prescriptions account for an estimated 21 percent of overall drug use, according to a 2006 analysis in the Annals of Internal Medicine. The practice is common in treating conditions such as cancer, where doctors will prescribe drugs approved for one type of cancer for another.” The proposed rule will fill a gap in the law created when a law governing the practice expired in 2006. Rep. Henry Waxman (D Calif) plans to examine the proposed rule.

The Health IT Now Coalition, which is co-chaired by former Congresswoman Nancy Johnson is clamoring for Congress to pass a health information technology bill such as the Wired for Technology Act. The privacy zealots are clamoring for Congress to enact greater restrictions on health information technology. This week Rep. Ed Markey (D Mass) and Rep. Rahm Emmanuel (D Ill.) introduced the Technologies for Restoring Users’ Security and Trust (TRUST) in Health Information Act (HR 5442)

Government Health Information Technology magazine explains that the TRUST bill, like the Wired for Technology bill, “would provide grants and establish a standards-setting process to foster a nationwide health information exchange network. But the TRUST bill differs from the others by calling for:

• • An opt-in system that would require patient consent before records could be kept in electronic systems.
• • Mandatory notification of any privacy breaches in health IT systems.
• • Requirements for encrypting data and taking other security measures to protect records from unauthorized access. “

The Markey bill is endorsed by the Deborah Peel, chair of Patient Privacy Rights, and Microsoft (you can draw your own conclusions.)