Patients who undergo complete prostate removal are less likely to experience urinary incontinence or other complications if the operation is done by an experienced surgeon in a hospital that does many of the procedures, according to a report funded by the Agency for Healthcare Research and Quality (AHRQ), part of the U.S. Department of Health and Human Services.

However, the new report concludes that scientific evidence has not established surgery or any other single treatment as superior for all men. The analysis compared the effectiveness and risks of eight prostate cancer treatments, ranging from prostate removal to radioactive implants to no treatment. An article based on the report is posted on the online version of the Annals of Internal Medicine.

“This report is a reminder that patient outcomes may vary according to treatment settings,” said Carolyn Clancy, MD, director of AHRQ “But this analysis also underscores a broader message: when it comes to prostate cancer, we have much to learn about which treatments work best, and patients should be informed about the benefits and harms of treatment options.”

In 2007, about 218,000 men were diagnosed with prostate cancer, and about 27,050 men died from the disease, according to figures from AHRQ.

The lifetime risk of being diagnosed with prostate cancer has nearly doubled to 20% since the late 1980s, due mostly to expanded use of the Prostate Specific Antigen (PSA) blood test. But the risk of dying of prostate cancer remains about 3%. Therefore, considerable overdetection and overtreatment may exist.

The U.S. Preventive Services Task Force, a panel of outside experts convened by AHRQ that makes independent evidence-based recommendations, maintains there is insufficient evidence to recommend for or against PSA testing for routine prostate cancer screening. PSA tests can detect early-stage cancer when it is potentially most treatable but also lead to frequent false-positive results and identification of prostate cancers unlikely to cause harm.

AHRQ said that its report is based on a review of 592 published articles, compared eight prostate cancer strategies: complete surgical removal of prostate and related tissue; minimally invasive surgery to remove the prostate; external radiation; radioactive implants; destruction of cancer cells through rapid freezing and thawing; removal of testicles or hormone therapy; high-intensity ultrasound; and no immediate treatment, also known as “watchful waiting.”

The report, compiled by AHRQ’s Minnesota Evidence-based Practice Center, is intended to provide evidence-based information so that patients, clinicians and others can make the best treatment decisions possible. Among its conclusions:

Not enough scientific evidence exists to identify any prostate cancer treatment as most effective for all men, especially those whose cancers were found by PSA testing. However, more than 90% of patients reported they would make the same treatment decision again, regardless of the treatment they received.

AHRQ said that the chances for bowel problems or sexual dysfunction are similar for surgery and external radiation. Leaking of urine is at least six times more likely among surgery patients than those treated by external radiation.

One study showed that men who choose surgery over watchful waiting are less likely to die or have their cancer spread. The benefit appears to be limited to men under 65. However, because few patients in this study had cancer detected through PSA tests, it is unknown if this finding would apply to those whose cancers were detected through PSA screening. Another smaller study showed no difference in survival between surgery and watchful waiting.

Among patients who choose surgery, urinary complications and incontinence are less likely if their surgeons performed more than 40 prostate removals per year.

Surgery-related deaths, urinary complications and readmissions were lower and hospital stays were shorter in hospitals that performed more prostate removals.

A lack of research makes it impossible to compare several treatments: rapid freezing and thawing (cryotherapy); minimally invasive surgery (laparoscopic or robotic assisted radical prostatectomy); testicle removal or hormone therapy (androgen deprivation therapy); and high-intensity ultrasound or radiation therapy.

Adding hormone therapy prior to prostate removal does not improve survival or decrease recurrence rates, but it does increase the chance of adverse events.

Combining radiation with hormone therapy may decrease mortality. But compared with radiation treatment alone, the combination increases the chances of impotence and abnormal breast development.

Also from AHRQ: needed, better systems for error reporting

The “rubber” concerning clinical mistakes meets the “road” in the minds of physicians — especially in the methods available for reporting errors, according to another new study by the Agency for Healthcare Research and Quality. The study suggests that there is a clear need for updating and formalizing the systems for reporting these mistakes.

Carolyn Clancy, MD, head of AHRQ, said in early January that a new survey shows that physicians “say they want to learn from errors that take place in their institution to improve patient safety. We need to build on that willingness with error-reporting programs that encourage their participation.”

She says the study indicates that physicians are willing to report and learn from medical errors, rather than, according to the general perception, that they resist doing this. Because most doctors think that current systems to report and share information about errors are inadequate, they rely instead on informal discussions with their colleagues.

“Consequently,” the organization said in a statement, “important information about medical errors and how to prevent them often is not shared with the hospital or the healthcare organization.”

“These findings shed light on an important question — how to create error-reporting programs that will encourage clinician participation,” Clancy said.

To assess physicians’ attitudes about communicating errors with their colleagues and healthcare organizations, study authors used a 68-question survey to poll a geographically diverse group of more than 1,000 physicians and surgeons practicing in rural and urban areas in the states of Missouri and Washington, between July 2003 and March 2004.

Most physicians reported that they had been involved in an error – 56% reported a prior involvement with a “serious error,” 74% with a “minor error and 66% with a near miss. More than half (54%) agreed with the statement that “medical errors are usually caused by failures of care delivery systems, not failures of individuals.”

Other findings:

• Almost all (95%) physicians agreed that they needed to know about errors in their organization to improve patient safety, and 89% agreed that they should discuss errors with their colleagues.

• 83% said they had used at least one formal reporting mechanism, most commonly reporting an error to risk management (68%) or completing an incident report (60%).

• Few physicians believed that they had access to a reporting system that was designed to improve patient safety, and nearly half (45%) did not know if one existed at their organization.

• Only 30% agreed that current systems to report patient safety events were adequate.

MedPAC seeks Medicare funding linked to accountability

The Medicare Payment Advisory Commission (MedPAC), meeting in mid-January, offered a preview of what might appear on the commission’s report to Congress in June regarding fee-for-service medical care.

Another theme of the meeting was that public and private payers have similar problems and should adopt similar approaches.

MedPAC staffer David Glass said that “sustainability might still be an issue” even if quality of care improves. He referred to the recent Congressional Budget Office report that took the position that the higher cost per beneficiary, not the greater number of beneficiaries, “is the prime driver of cost growth.”

“We would want any policy to promote accountability and care coordination,” Glass said. Policy should also emphasize incentives to “higher efficiency – both lower-cost production and higher quality – rather than increases in volume.”

In a statement that seemed to hint at potential further privatization of Medicare, Glass said that “promoting alignment with the private sector would provide greater leverage and decrease administrative burden.”

He said: “The basic problem with the fee-for-service system is ... reward for services” rather than outcomes, and that “marginal rewards may be insufficient to change [provider] behavior.”

Among the potential changes to Medicare proposed in the past is the concept of the medical home, but Glass said that bundled payments might also have an ameliorative impact on Medicare inflation.

However, a relative newcomer to the table drew attention. Glass said that the accountable care organization (ACO) “is a broader concept” that would put the patient in a system that “would be held accountable for costs and outcomes.”

An ACO would consist of doctors, hospitals and other providers that would offer seamless care throughout the stages of treatment.

This kind of coordination would seemingly require integrated healthcare information technology and also that doctors would be willing to give up at least some autonomy.

Needless to say, other tripwires abound. Given that such a system would involve more than one provider and more than one type of provider, Glass asked rhetorically: “Should incentives be based on individual or group performance?” He said the answer would indicate willingness to participate.

Specialty hospital group says OIG report is ‘blatantly false’

Physician-owned specialty hospitals have been the target of congressional ire for a pair of incidents involving fatalities, but they have also been the subjects of reimbursement activity on the part of the Centers for Medicare & Medicaid Services as well. A recent report by the Office of Inspector General (OIG) at the Department of Health and Human Services cast an even less-flattering light on these hospitals, but an association for physician-owned hospitals (POHs) blasted the report as inaccurate and a reflection of shoddy work by OIG.

The history of the POH is replete with controversy. CMS had imposed a ban on payments to physician-owned specialty hospitals in 2003 over concerns about resource use, which was lifted in October 2006. Also, the Medicare Modernization Act of 2003 imposed an 18-month moratorium on development of any new such hospitals.

Much of the recent controversy revolves around two episodes, one in 2005 and one in 2007, in which a patient died after a specialty hospital transferred the patient to another hospital via a 911 call. Both patients had elective surgeries and neither hospital had a physician on duty when the emergency occurred. These and other considerations led the Senate Finance Committee to request that OIG conduct a review of these hospitals.

Among the OIG’s findings are that more than one in five of the 109 hospitals reviewed had no written policies for evaluating and dealing with emergency situations, which is a CMS requirement. OIG also said in its report that 34% of the hospitals rely on 911 services for emergency care and that less than a third of the 109 had a physician on site at all times.

Molly Sandvig, executive director of Physician Hospitals of America (Sioux Falls, South Dakota) told BB&T, “We continue to support the OIG’s recommendations to CMS,” which included development of a system to identify and regularly track physician-owned specialty hospitals and to ensure that these hospitals have a registered nurse on site 24/7.

However, Sandvig said of the OIG’s conclusions: “We’re confident that it’s blatantly false. It’s either a case of people at OIG in not understanding what they’re reading” or not correctly interpreting CMS regulations, he said, adding that “It appears that there was a lack of follow-up” to validate the initial findings when they were contested.

“There were 37 hospitals named in the report as having suspect emergency policies, using 911 for purposes of stabilization,” Sandvig said, adding “none of the hospitals I talked to have policies that matched the OIG’s accusations.”

OIG gives okay to gainsharing program

In other OIG-related news, two recent decisions show that hospitals and doctors can walk the fine line of entering into cooperative agreements.In a Dec. 28 decision, OIG said that it would not oppose an arrangement made between a hospital and a cardiac surgery group in which “the hospital agreed to pay the surgical group a share of cost savings directly attributable to specific changes in the group’s operating room practices.”

The changes in part involve an evaluation of cardiac devices and supplies that the surgeons would standardize. The surgeons also agreed to “refrain from opening disposable components of the cell saver unit until the patient experiences excessive bleeding.” Other agreed-upon changes include as-needed use of a series of surgical supplies and the substitution of unspecified surgical products for those of lower cost.

The surgical group, according to the decision memo, “is the only group of cardiac surgeons that practices at the hospital,” described as an acute care hospital doing business with Medicare and Medicaid. All identifying information was purged by OIG before posting to the web site.

OIG said that part of the rationale for allowing the arrangement was that “the circumstances and safeguards of the arrangement reduced the likelihood that the arrangement was used to attract referring physicians” due to the fact that participation was limited to surgeons already with the practice. OIG also noted that while “many of the recommendations ... are simple common sense, they did represent a change in operating procedure.” Still, because the changes “carried some increased liability risk for the physicians,” it is “not unreasonable for the surgeon to receive compensation for the increased risk.”

In a similar decision issued in connection with a gainsharing arrangement between a hospital and an anesthesiology practice, OIG said that it would not object to shared savings engendered by product substitutions and standardizations as well as for the use of as-needed items. In this last category was the elimination of the use “a specific drug, and a device to monitor patients’ brain function” during cardiac procedures.

The OIG memo also noted that the hospital program administrator “tracked and measured the hospital’s performance of the covered cardiac procedures against the quality indicators established by the Society of Thoracic Surgeons (Washington) throughout the base year and contract year,” concluding that no cost-sharing was predicated on “procedures involving reductions in historical STS quality indicators.”

CMS eyes standards rewrite for obstructive sleep apnea

The potential for obstructive sleep apnea (OSA) leading to heart disease makes the condition compelling for insurance coverage. The Centers for Medicare & Medicaid Services has proposed rewriting its standards for reimbursement for continuous positive airway pressure (CPAP) devices as well as for what the agency will accept as a diagnostics for obstructive sleep apnea (OSA).

In January 2007, CMS received a letter from the American Academy of Otolaryngology (AAO; Alexandria, Virginia) to take another look at whether home testing should be sufficient to diagnose the condition. According to the association’s letter, in-lab polysomnography is “an expensive test that is not widely available.”

The AAO letter stated that 24% of men employed by the federal government in Wisconsin had OSA, as did 9% of women in that same group, with the threshold of five events per night as a diagnostic criterion. AAO also said that “several studies document the prevalence increases with age can certainly support a prevalence of 10% or more for Medicare patients 65 or older.” And “more than 800,000 drivers were involved in OSA-related motor vehicle collisions in 2000, costing $15.9 billion and 1,400 lives,” it said.

One testing paradigm recommended by AAO is to use CPAP machines in the home.

Anyone who is suspected of suffering from a sleep-related breathing disorder but not able to tolerate the use of CPAP would then be forwarded to in-lab polysomnography, a test requiring extensive wiring and an overnight stay in a sleep lab.

The agency issued a decision in mid-December proposing that coverage for CPAP, as an in-home diagnostic, will be initially limited to 12 weeks to aid in the effort to positively identify those with OSA, and Medicare would pay off the device for any such patients who respond positively.

BioEnterprise: devices trump pharma in interest, not investment

In the Midwest, medical devices are viewed as a primary sector of interest for investors, surpassing even biopharmaceuticals, according to the Midwest Health Care Venture Survey conducted by BioEnterprise (Cleveland), results released in mid-January.

A total of 45 healthcare investors from across the country responded to the survey, with respondents represent funds with a strong interest in the healthcare technology space. Of those, 95% invest more than a quarter of their funds in healthcare.

About 82% of the respondents reported that they invest in at least one Midwest healthcare venture each year, and 90% identified themselves as “knowledgeable” about Midwestern healthcare opportunities.

The telling evidence of their primary focus comes from 94% of the 45 respondents indicating an interest in medical devices, with 65% of the respondents indicating an interest in biopharmaceuticals (respondents could indicate interest in multiple areas). Nearly 55% indicated an interest in healthcare services, and 44% showed interest in healthcare software.

About 72% of investors rated medical device deal flow to be strong in the Midwest; while only 16% rated Midwest biopharmaceutical deals as strong.

But when it comes to actual investor dollars being spent, data seems to suggest that the biopharmaceutical sector was more robust in terms of investments attracted. Biopharmaceutical companies captured nearly 50% of the invested dollars in the region, according to the 3Q07 Midwest Health Venture Report – suggesting a higher per-deal investment in pharmaceuticals than in devices or healthcare software.

So if more money is being spent in biopharmaceutical deals, why is it that medical devices or so popular? Is it a perception issue, or a change in traditional thinking?

Baiju Shah, president of BioEnterprise, said, “As to investors’ perceptions, it is interesting that the Midwest’s strong historic position in medical devices continues to drive the regions’ reputation, even though actual investments show that Midwest biopharmaceutical companies are drawing significantly more dollars [per deal] than medical device companies.”

The survey also illustrates the tidal wave of healthcare investments that have bombarded the Midwest of late.

Midwest healthcare start-ups reported a record-breaking $1 billion in total investments for 104 companies through 3Q07, according to a report released by BioEnterprise last October.

The previous report showed that by industry sub-sector, the investment funding broke down as follows:

• Biopharmaceutical companies, $591 million.

• Medical device companies, $251 million.

• Healthcare software and service companies, $158 million.

“Not surprisingly, the 2007 survey results mostly reflect what we have seen in terms of actual venture investing in the Midwest,” Shah said. “Through the third quarter, Midwest healthcare start-ups reported a record-breaking $1 billion in venture investments, up from $783 million reported in 2006. Clearly, investors are finding good opportunities in the Midwest and the deals are performing for them.”

Some of the regions leading in investments are Minneapolis, Cleveland and Pittsburgh. These three regions have the highest reputations among venture investors for the quality of healthcare deals, Shah said. Wisconsin, Indianapolis, Cincinnati, St. Louis round out the middle, while Chicago, Columbus, Kansas City and Kentucky are at the bottom of the list.

CMS says healthcare inflation slowed a bit in 2006

CMS reported some good news and bad news early last month. The good news: the acceleration of healthcare inflation in 2006 was less than in the previous year. The bad news: healthcare spending rose 6.7% in 2006.

The agency’s Jan. 8 announcement said that spending in 2006 came to $2.1 trillion, or more than $7,000 per person. The figure for 2005 is $6,649 per person. However, the agency noted that the share of GDP “remained relatively stable in 2006 at 16.0%, up by only 0.1% from 2005.”

Thanks largely to Medicare Part D, out-of-pocket spending grew only 3.8% in 2006, a relatively torpid pace compared to the 5.2% growth the previous year. This category, all told, “accounted for 12% of national health spending in 2006,” but has “steadily declined since 1998, when it accounted for 15% of health spending.”

According to the report, “[t]otal prescription drug spending in 2006 was $216.7 billion, compared to $199.7 billion in 2005.” Public funding sources was said to have accounted for 34% of this total “whereas in 2005 their share was approximately 28%.”

Left behind: FDA warns doctors about device fragments

Speaking of medical error reporting, FDA recently published a “Dear Healthcare Practitioner” letter that addresses a category of events that would seem to be covered by the law of unintended consequences, urging surgeons to be more cautious in the use of devices during surgery and to be more conscientious in reporting any such events to the agency.

The letter says that unretrieved device fragments are the subjects of “nearly 1,000 adverse event reports each year” in connection with “more than 200 different medical devices and numerous medical specialties.”

As examples of potential problems from unretrieved fragments, the letter cites the possibility that magnetic resonance imaging (MRI) fields “may cause metallic fragments to migrate” and the associated radio-frequency energy field “may cause [the fragments] to heat, causing internal tissue damage and/or burns.”

Among the adverse events that FDA has seen reports for are local tissue reaction, perforation and blood vessel obstruction. Deaths have also been reported, although the agency offered no specific numbers.