Whistleblower Gets $1M
Administrator Topples Pain Management Billing Scheme
The former administrator of an anesthesia services provider will collect more than $1 million in whistleblower fees after helping the government recover almost $3.8 million in billings to Medicare and Medicaid, according to court records.

In a 2001 lawsuit, Robert J. Allen, who managed Atlanta-based Physician Specialists in Anesthesia in 1997, accused his former employer and the Resurgens Surgery Center, an orthopedic outpatient surgical clinic on the campus of St. Joseph's Hospital of Atlanta, of collusion in improperly billing the government insurers.

PSA had neither a certificate of need nor a federal provider number, which means it couldn't bill Medi-care or Medicaid for facility fees.

But according to court filings, that's precisely what happened. PSA anesthesiologists were allowed to treat their patients for pain in Resurgens' outpatient surgical suites and subsequently bill the government for facility fees using Resurgens' provider number. Then, PSA would kick back a portion of those reimbursed facility claims to Resurgens, court filings alleged.

Resurgens' facility fee reimbursements were steered to a lockbox at an Atlanta bank. Once a month, Resurgens and PSA staff would divvy up the reimbursements, court filings alleged. Mr. Allen witnessed the division, which the whistleblower was told had been standard practice since 1993, according to court filings.

Resurgens last month agreed to repay the federal government $2.5 million in Medicare and Medicaid billings. In a June 2004 settlement, PSA agreed to repay the government $1.3 million. Neither PSA nor Resurgens admitted wrongdoing as part of the settlement.

"The Resurgens doctors believed they had done nothing improper," says Charles Murphy, the lawyer for the surgery center, in a statement issued after the settlement, "and had received professional assistance from lawyers and business consultants at the time of the questioned billings to assure compliance" with Medicare regulations.

According to the agreement, made under the federal whistleblower statute, Mr. Allen will receive 28 percent of the recovered federal funds and an additional $225,000 in legal fees for his role in revealing what court filings describe as fraud. No criminal charges have been filed.

- David Bernard

Bariatric Surgery
CMS Urged to Expand Obesity Coverage
Medicare should cover more bariatric surgery, says the American Society of Bariatric Surgeons (ASBS) in a letter to CMS last month. ASBS President Harvey J. Sugerman, MD, FACS, authored the letter on behalf of the surgeons group and the American Obesity Association, Ethicon Endo-Surgery, Inamed Corp., U.S. Surgical and Transneuronix Corp. Medicare's variable coverage for bariatric surgery only covers co-morbidities, which vary by region. "We feel there needs to be more uniform coverage, and that all weight-loss procedures should be covered," says Dr. Sugerman. He asks that CMS expand coverage at the patient level to include patients with a body mass index greater than 40, "regardless of co-morbidity status," and patients with a BMI greater than 35 who have one or more of 18 standardized co-morbidities.

- Stephanie Wasek

Execution by Injection Far From Painless?
Study: Inadequate Anesthesia May Cause 4 in 10 to Stay Conscious
Four of every 10 prisoners executed by lethal injection might receive inadequate anesthesia, leaving them conscious and in extreme pain during their executions, say researchers who reviewed the levels of anesthetic in the blood of 49 inmates after their deaths.

Of the 49 thiopental levels drawn from the executed and studied in a report published by the British journal The Lancet, 43 percent had concentrations of anesthetic in their blood - as measured by medical examiners during autopsies - that would indicate consciousness rather than sedation during an execution. "Those numbers suggest that there were a number of condemned with low levels of thiopental in their blood at death. It's a hard sell to say that person was adequately sedated." says the study's lead author, Leonidas Koniaris, MD, chairman of surgical oncology at the University of Miami.

Death by lethal injection typically involves the injection of three substances: first, sodium thiopental (also called sodium pentothal), to induce anesthesia, followed by pancuronium bromide to relax muscles and finally potassium chloride to stop the heart. An inmate will typically receive up to 3 grams of sodium thiopental - about 10 times the amount given before surgery. A normal surgical dose for a man weighing 220 pounds would be about 300 milligrams.

Texas state senator and anesthesiologist Kyle Janek, MD, a vocal advocate of the death penalty, insists that levels of anesthetic are more than adequate. "I can attest with all medical certainty that anyone receiving that massive dose will be under anesthesia," he says in a Houston Chronicle editorial.

A critical question, the study authors admit, is whether measurements of the levels of sodium thiopental in the blood minutes or hours after death correlate with levels in the blood at the time of execution.

- Dan O'Connor

Informed Consent
Hospitals Must Comply With CMS's Expanded Scope of Informed Consent
Onerous is how some are describing the informed-consent guidelines CMS surveyors are now using. Under the guidelines, hospital OR managers must not only inform patients who will actually perform the planned surgery, but also "when practitioners other than the primary surgeon will perform important parts of the surgical procedures, even under the primary surgeon's supervision." These parts include opening and closing, harvesting grafts, dissecting tissue, removing and altering tissue and implanting devices.

The names of the nurses and other personnel who provide patient care, but do not directly perform the procedure - such as the circulating nurse, scrub tech and X-ray tech - do not need to appear on the surgical consent form. But if other surgeons, residents or non-physicians assist with surgery, their names and surgical roles must be included.

Freestanding ASCs should prepare for the day when they, too, will have to disclose to patients the names and credentials of everyone participating in the case before any surgical procedure can be performed, says Tom Cooper, executive director of AORN. "It would not be unreasonable to think that at some point, these informed-consent guidelines could apply to ambulatory surgery centers," says Mr. Cooper. "It would be prudent to anticipate that this could apply to ambulatory centers."

AORN is planning to suggest that CMS revise the guidelines to give the OR staff "more latitude with respect to how they identify who's participating in the procedure," says Mr. Cooper. CMS has indicated it will modify the informed-consent guidelines to address last-minute changes to participants in surgery.

To learn more, go to www.cms.hhs.gov. Enter A-0238 in the search field. A 307-page document will open. Scroll to pages 161 and 162 for details on informed consent.

- Dan O'Connor

Vanity Tax
Since September, when New Jersey became the first state to tax plastic surgery, at 6 percent, lawmakers in Illinois, Texas, Washington and Tennessee have tried but failed to do likewise. In Illinois, a 6 percent tax to fund a controversial stem cell research initiative was removed from the bill. In Texas, where a 7.5 percent tax had been approved by the House as part of a budget bill, the amendment was removed. And in both Washington (6.5 percent) and Tennessee (7 percent), proposals died in committee.

Accreditation by Proxy
Corporate-owned surgery centers can be JCAHO-accredited without a surveyor ever setting foot in such facilities under the Joint Commission's new system model of accreditation. JCAHO's system model awards a single accreditation decision to a group of healthcare organizations whose many sites typically provide the same type of services, have the same governance and meet other criteria for consideration as a system. JCAHO says it developed the model to offer systems in ambulatory healthcare and home care programs with a credible and affordable accreditation product. JCAHO says it will test this approach on a limited number of corporations this year before deciding whether to extend the program.

Help for ASC State Associations
The American Association of Ambulatory Surgery Centers has launched a state advocacy program designed to help the country's 41 state groups defend themselves against such anti-ASC measures as restrictions on physician ownership, provider taxes, and onerous certificate-of-need and licensure requirements. "Perhaps the most significant outcome of this new state advocacy program is that it lets AAASC and state associations develop a positive, proactive state agenda, rather than responding from a defensive posture to anti-ASC measures," says AAASC Executive Director Craig Jeffries.

Nurse-administered Sedation
A coalition of Illinois ASCs, hospitals, physicians and public health officials are planning legislation that would let nurses with advanced training and a physician's direction administer Versed for mild to moderate conscious sedation. The proposal aims to increase patient safety primarily in GI endoscopy labs, where the operating physician may also monitor anesthesia use, says Mark Mayo, executive director of the Illinois Freestanding Surgery Center Association.

Are Endo Suites ORs?
North Carolina's current medical facilities plan includes endoscopy rooms under the heading of operating rooms, without distinguishing for specialties. As a result, obtaining a certificate of need to develop an office-based endoscopy center depends on the state health coordinating council's assessment of the need for an OR in the area. An advisory panel to the council, however, has recently discussed the possibility of amending the plan to separate endoscopy rooms from ORs, given the rising demand for colonoscopies and cancer screenings. The panel hasn't yet recommended the council take such action, says medical planning consultant David Legarth of Apex, N.C., who describes the issue as "very preliminary."

- Compiled by Outpatient Surgery staff