Post-op Pain Management
Insurers Nix Reimbursement for Home Infusion Pumps
Cigna, Aetna and United Healthcare say they won't reimburse for pain pumps used to infiltrate analgesic into surgical incisions or intra-articular spaces, citing insufficient clinical evidence for these devices.

The policy decision comes despite 2003 ASA guidelines supporting postincisional infiltration to help control pain after surgery; more than 50 studies published in the five years since the pumps were introduced, showing that they reduce the need for narcotics and help patients get back on their feet sooner; and the FDA's OK for I-Flow Corp., makers of the On-Q PainBuster, to label for this efficacy claim: "On-Q offers significantly better pain relief than narcotics and significantly reduces the need for narcotics."

According to Cigna, new studies have cast doubt on ASA's earlier assessment of the literature. Both Cigna and Aetna cite conflicting study results, poorly designed protocols and a general lack of universal dosing guidelines as their basis for denying coverage.

"The trouble is, acute pain billing in general is abysmal," says Eugene Viscusi, MD, director of acute pain management at the department of anesthesia at Thomas Jefferson Medical College in Philadelphia. "We really need a consensus on what works and the cost of each particular technique. Then we can aggressively present this to third-party payers."

I-Flow says it has managed care contracts with plans covering 30 million patients to provide reimbursement for the pumps in outpatient surgery centers nationwide. In a bulletin distributed to its sales reps, I-Flow says on average, it receives payments representing 35 percent of what it bills to contracted as well as non-contracted policies.

The insurers' no-pay policy adds uncertainty to an already-murky area for pain practitioners. The subjective nature of pain and the fact that it can have different sources even in patients who undergo the same procedure can render pain and its treatment unpredictable. Manchester, N.H.-based plastic surgeon Peter T. Pacik, MD, says that while analgesic infiltration into the implant pocket in breast augmentation patients helps alleviate pain in 90 percent of women, others experience significant sternal pain that is unresponsive to infiltration. This pain, caused by stretching of the pectoral nerve, responds much better to narcotics, he says, than to the local anesthetic such as lidocaine in which most home infusion pumps continuously bathe surgical wounds.

Examples like this, however, illustrate why some practitioners warn against letting insurers' policy pronouncements drive patient-care decisions. "Clinicians performing these techniques should examine the available studies for the specific applications they are using to determine if there is a substantial benefit versus cost, particularly if there isn't reimbursement. In other words, if you are doing these techniques, it should be driven by benefit, not reimbursement," says Dr. Viscusi.

Indeed, despite the insurers' policy decision, recent studies support the analgesic efficacy of post-incisional analgesia in certain patients, including those undergoing open inguinal hernia repair, tonsillectomy or laparoscopic cholecystectomy. Small-scale studies have shown home infusion pumps help patients recover their range of motion and engage in physical activity sooner, and reduce the likelihood of chronic pain from their surgeries.

Dr. Viscusi also advises against taking this policy decision out of context. That is, the modern approach to pain is typically multimodal, and local infiltration may play a worthwhile role.

- Dianne Taylor

Single-use Devices
Feds to Investigate Reprocessing, Reuse of SUDs
If you employ a third party to reprocess some of your single-use surgical devices, your supply budget could get a little tighter, depending on the outcome of Government Accountability Office scrutiny. Congress's investigative arm will look at the safety of using reconditioned medical devices designated for one-time use and the government's oversight of the practice.

In a letter to Comptroller General David W. Walker, Rep. Tom Davis (R-Va.) and Rep. Henry A. Waxman (D-Calif.) write that they are "alarmed" by "many instances of patient injuries associated with the use of defective or unsterile reprocessed single-use medical devices" and "the lack of independent information available about the safety of the reprocessing of single-use medical devices."

The Association of Medical Device Reprocessors is "confident that the GAO will ? issue a report confirming that the industry is stringently regulated and reprocessed devices are safe," says spokesman David Sheon.

One of the chief concerns for facility managers is the cost more oversight could bring.

"It would significantly impact my supply budget if the federal government decided not to allow reprocessing," says one ASC manager who wished to remain anonymous to protect budget privacy. "In just nine months, we've saved more than $51,000. [Reprocessors] stand behind their products 100 percent. ? I have been very pleased with their services."

The FDA did not return requests for comment, but a spokeswoman said in published reports that the agency engaged in strict oversight of the SUD-reprocessing industry. The GAO has yet to determine the scope and timing of the investigation, says its spokesman, Paul Anderson.

- Stephanie Wasek

News You Can Use

• USPI to buy Surgis. United Surgical Partners International, Inc., of Dallas will acquire its biggest privately held competitor, Surgis Inc., of Nashville. The purchase price is estimated to be $215 million to $230 million. The companies expect the deal to close within three months. Surgis operates 24 surgery centers and has seven others under development. The company also owns American Endoscopy Services, which provides instrumentation, supplies and personnel to 42 traditional acute-care hospitals. Publicly traded USPI owns or operates 104 surgical facilities.
• CON Laws, Part I. Physicians are making another large push to protest a Georgia law that governs which types of doctors can own ASCs. Physicians who are considered single-specialty, such as orthopedic or plastic surgeons, do not have to go through the long and often-contentious CON process. But general surgeons aren't considered to be single-specialty, so the American College of Surgeons pledged Jan. 4 to boycott the state as a site for future conventions or meetings until the law is changed.
• CON Laws, Part II. Under new Michigan CON rules, only surgeries done in an OR may be counted when applying for more surgery space. Procedures such as colonoscopies will not count. State officials say they want existing hospital ORs at full capacity - about 1,200 cases a year per OR - before any new ORs are built.
• Illinois hospitals asked to step up charity work. Illinois Attorney General Lisa Madigan has proposed a bill that would require hospitals with state-tax exemptions to spend at least 8 percent of their operating costs on uncompensated care, including Medicaid shortfalls, bad debt and charity care. Hospitals could count care provided at their clinics; critical-access hospitals would be exempt from the requirement. Ms. Madigan says Illinois' 200 or so not-for-profit hospitals provided charity care amounting to less than 1 percent of their total charges, on average, in 2003. The state's nonprofit hospitals are required to provide charity care - although current law doesn't set a specific amount - in exchange for exemptions from income, property and sales taxes. Another state Senate bill, the Ambulatory Surgery Treatment Act, would require ASCs to submit a plan to the state Department of Public Health with figures on the number of indigent and Medicaid patients, and how ASCs will serve them.

A Better Way to Say Goodbye
Pa. Study Suggests Ways to Improve Discharge Procedures
When you discharge a patient from your surgery center, can you wave goodbye as well to your clinical responsibility? Not necessarily, say patient safety officials in Pennsylvania, who found that patients who required hospital-level care for complications within hours or days of an outpatient surgical procedure may have benefited from more detailed discharge instructions and more structured patient-provider communication.

"Unlike post-operative discharge from a hospital, [ASC] discharge occurs within hours of the surgical procedure," say officials with the Pennsylvania Patient Safety Authority.

In 12 of 100 randomly selected cases where an outpatient surgery patient ended up at the hospital, they say, the way that surgery centers handled discharge and post-discharge follow-up might have contributed to a subsequent trip to the hospital (in nine cases) or emergency room (in three cases).

"Just because patients leave us hours after surgery doesn't mean that they haven't had a major assault on their body and that they don't need care," comments Nancy Combs, RN, the director of perioperative services at John C. Lincoln Hospital in Phoenix, Ariz. "Oftentimes our post-op instructions are focused too much on the short term."

Coming up short
Here are examples where safety officials say surgery centers' discharge procedures came up short:

• A patient calls the surgery center to complain about severe pain. The ASC tells him to take his pain medication. The pain persists. The man goes to the ER and is diagnosed with urinary retention. Staff place a Foley catheter in him, give him IM medication and discharge him. The ASC should have made an effort to find out the location of the patient's pain.
• About 48 hours after an ASC discharges a patient, he calls the doctor to complain about bleeding. He is admitted to the hospital. The patient had taken aspirin. The surgery center might not have sufficiently cautioned the patient that aspirin can cause or increase the risk of bleeding.
• A patient with a history of ulcerative colitis had a colonoscopy that included two polypectomies and several biopsies. Six days later, he called the doctor's office to report blood in the stool - his first bowel movement since his procedure. The patient was admitted to the hospital and received a unit of packed red blood cells. The surgery center should have given the patient a specific timetable as to when he should call about lack of bowel movements.
• A patient reported to an ER complaining about abdominal pain three days after a colonoscopy with hot biopsy polypectomy. Staff there found he had free air in the bowel. Doctors found a perforation and did a colon resection. The surgery center should have told the patient to report abdominal distention.

Causes for concern
The report also had recommendations about specific patient outcomes that should cause concern:

• Bleeding. The report suggested that surgery centers do a better job explaining to patients what to expect as far as bleeding when they return home. Bleeding is the primary reason that patients go to the ER after an outpatient surgery, says the report. But often patients don't know how much bleeding is cause for worry or how they can stop some bleeding themselves by applying pressure to the wound or reinforcing dressings. Also let patients know when to call you instead of going to the ER.
• Pain. Communicate to the patient what surgical site pain or discomfort they should expect when they return home and the analgesia wears off. Explain to patients the universal use of a scale of 1 to 10 to describe the pain they're feeling, says the report. Similarly, doctors and nurses can use the 1-to-10 pain scale to give the patient some idea of when the anesthesia will be wearing off and what pain the patient will be feeling then. Surgeons can also explain the trade-offs with different approaches to analgesia. "Patients can then be active in decisions about their care," says Ms. Combs. At the same time, tell patients that it's better to maintain control of pain rather than regain it after it has been lost.
• Resuming medications. Surgery centers should pay attention to medications the patient is taking regularly at the time of the operation - especially anticoagulants. At one center, a tonsillectomy patient, after reading his discharge form saying he could resume his medications, took some Coumadin. Bleeding forced him to the hospital, where he was admitted. The surgery center has since changed its discharge instructions so that anticoagulants are flagged during the pre-operative review, says the report.

The report recommends that physicians review each medication for risks related to the surgical procedure before giving permission to the patients to resume taking their regular dose.

• Patient compliance. The report warns that patients are likely to disobey rules about avoiding alcohol, delaying driving and having a caregiver available to help them at home. "Thoroughly explain the reasons for the instructions as well as their importance," says Ms. Combs. "Help patients to comply with them."

- Dan O'Connor

Tips for Improving Discharge

• Provide well-defined, objective criteria for calling the doctor or seeking follow-up care.
• Discuss pain expectations, effects of anesthesia and alternatives with patients.
• Explain incisional bleeding, dressings and pressure dressings to patients.
• Give clear instructions regarding when they should call the surgery center because of bleeding.
• Review the medications patients were taking before the operation and give specific instructions as to when they should resume them.
• Reinforce the risk of driving and drinking alcohol too soon after the procedure, and the need to have a supportive caregiver at home.

SOURCE: Pennsylvania Patient Safety Authority

Six Reasons for Patients to Call
Instruct patients to call your surgery center if

• they have an elevated temperature over 100 degrees;
• their pain management isn't working;
• they have nausea or vomiting;
• they have excessive bleeding;
• they can't urinate (after a specified time based on the procedure) and
• they've had no bowel movement for more than 24 hours after the procedure.

SOURCE: Pennsylvania Patient Safety Authority

In Case You Missed It
A recap of the stories that appeared in our free E-Weekly e-mail newsletter over the last month:

• In a Sentinel Event Alert issued Jan. 25, JCAHO cited transitions as a high risk for patient injury or death due to drug duplication; drug incompatibility; incorrect, insufficient or unnecessary doses; or other medication errors.
• "Watchful waiting" may be an acceptable option for men with minimally symptomatic inguinal hernias. A study in the Jan. 18 Journal of the American Medical Association reports that the rare occurrence of acute hernia incarceration means that surgical repair can be delayed until symptoms increase.
• CMS has designated Advanced Medical Optics' Tecnis IOL as a new technology intraocular lens, creating a new class of NTIOLs, "reduced spherical aberration," and making the Tecnis IOL eligible for an additional $50 payment when provided to a Medicare beneficiary in an ASC.
• A new study challenges the notion that patients undergoing plastic surgery procedures lasting longer than four hours are more likely to suffer anesthesia-related complications than those undergoing shorter procedures.
• Patients who drink a clear carbohydrate-rich drink before surgery have better immune system response than other patients, says a study in the Journal of Parenteral and Enteral Nutrition.
• Iowa Methodist Medical Center will restart its gastric bypass program, which it suspended in 2004 after the deaths of seven patients. The Des Moines hospital hired a new surgeon who is assembling a bariatric surgery team.
• Decide which child-and-parent pairs will benefit from parental presence during anesthesia induction on a case-by-case basis, says a study in the January 2006 Anesthesia and Analgesia. Researchers suggest that you need to implement a decision-making process that takes into account the anxiety levels of both parent and child.
• The FDA has cleared Staar Surgical's Myopic Vision Implantable Collamer Lens to enter the market. The lens's foldable design allows an incision that's up to 50 percent smaller than other lens, the company says.