11 Things to Know About the False Claims Act

1. Initial development of the False Claims Act. The False Claims Act, also known as the “Lincoln Law” after its primary proponent, President Abraham Lincoln, was initially developed during the Civil War. The Act was a response to war profiteering by military contractors who attempted to defraud the government, for example, by sending boxes of sawdust instead of guns or selling the same cavalry horse to the armed forces multiple times. The Act remained in its original form from its initial passage in 1863 until 1943, at which point various amendments de-incentivizing qui tam actions made the statute nearly obsolete. In 1986, the Act was amended again with greater incentives for private citizens to report fraud on the government. The Act has become an increasingly active mechanism to combat fraud and false claims submitted to the federal government ever since. For additional background information, see http://www.all-about-qui-tam.org/fca_history.shtml.

2. Overview of Qui Tam concepts. Qui Tam means “in the name of the king”. The concept of a Qui Tam action is similar to a whistleblower action and allows a private person, referred to as a “relator,” to file suit on behalf of the United States against those who have falsely or fraudulently claimed federal funds. Incentives are built in so that the qui tam relator is able to receive a part of the proceeds of a victory on behalf of the government. Further, the portion of an award amount that the relator retains is greater if the government does not join in the suit and therefore he or she does not receive the help of the government. Alternatively, if the government joins or “intervenes” in the lawsuit, the relator retains a lesser portion of any judgment or settlement obtained.

False Claims Act qui tam actions run the gamut of federally funded programs, from Medicare and Medicaid to defense and other government procurement contracts, federally insured mortgage and other federal housing programs, disaster assistance loans, agricultural subsidies and more. Persons who knowingly make false claims for federal funds are liable for three times the government’s loss plus a civil penalty of $5,500 to $11,000 for each claim. Relators recover 15 to 25 percent of the proceeds of a successful suit if the United States intervenes in the qui tam action, and up to 30 percent if the United States declines to intervene and the relator pursues the action alone. During fiscal year 2009 alone, relators were awarded $255 million. (This figure does not include relator shares awarded after Sept. 30, 2009.)

3. Top hospital recoveries. To see a list of the top 20 False Claims recoveries to date, go to www.taf.org/top20. Several hospitals and hospital companies have paid massive settlements to resolve false claims actions against them, including St. Barnabas Hospitals, a non-profit hospital chain in New Jersey, which paid $265 million in 2006 to settle allegations related to improperly claiming “outlier” Medicare payments (additional payments for particularly difficult or complex procedures). Also in 2006, Tenet Healthcare, a national hospital system, agreed to pay the federal government $900 million for billing violations also involving manipulation of outlier payments, as well as kickbacks, upcoding and bill padding. Similarly, in 2000, Columbia HCA, the largest for-profit hospital chain in the country paid more than $731 million to settle False Claims Act allegations against it. Currently, Toumey Healthcare System in South Carolina is involved in a False Claims litigation based on physician self-referral law violations that resulted in the submission of false claims, a legal theory that proved successful against a medical practice management company in the 2008 case U.S. v. Rogan in the Seventh Circuit Court of Appeals.

4. 2009 recoveries. In 2009, the U.S. government recovered $2.4 billion dollars under the False Claims Act. This was the second highest annual collection amount recorded in history, thanks in large part to an enormous settlement between the government and Pfizer Inc. The Department of Justice made the following statement regarding the Pfizer settlement in Sept. 2009:

American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. hereinafter together “Pfizer”) have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.

Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – i.e., any use not specified in an application and approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. The company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion.

In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs – Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs.

5. Healthcare fraud — Top industry for False Claims recovery. Healthcare fraud represents the largest and most profitable industry for Qui Tam false claims collections. Healthcare fraud recoveries accounted for approximately $1.6 billion, more than two-thirds of the $2.4 billion dollars collected under the False Claims Act in total during 2009. Numerous federal agencies shared in these recoveries, including the Department of Health and Human Services, in connection with its Medicare and Medicaid programs; the Office of Personnel Management, which administers the Federal Employees Health Benefits Program; the Department of Defense for its TRICARE insurance program; and the Department of Veterans Affairs.

6. Pharmaceutical and medical device companies – Main targets. The largest qui tam settlements in 2009 came from pharmaceutical and medical device companies, including Pfizer, Sanofi-Aventis, Bayer HealthCare, Quest Diagnostics and Eli Lilly, amongst others. The DOJ reported that pharmaceutical and device companies accounted for $866.7 million in settlements for federal recoveries, in addition to $402 million being returned to state Medicaid programs.

7. Retention of overpayments now can be considered a False Claims Act violation. In 2009, President Obama signed into law the Fraud Enforcement and Recovery Act of 2009 which implemented significant changes to the False Claims Act, including the expansion of prohibited conduct under the False Claims Act to include not just the improper filing to collect monies, but also the known retention of overpayments by hospitals or other health care providers. The 2009 amendments also make clear that false claims submission to a state Medicaid program, although not directly submitted to the federal government, does constitute a violation of the False Claims Act.

8. Hospital sample False Claims policy. All health care providers and businesses submitting claims to the government for payment should have health care regulatory and false claims policies in place to educate its employees and agents and minimize the submission of false claims and the potential liability attached thereto. A good sample policy is available online at www.centralcommunityhospital.com. This sample policy is particularly designed to address a community hospital’s approach to false claims and other policies, and may need to be modified depending on the size of the entity, breadth of practice, or type of industry or provider submitting the claims.

9. Plaintiff’s law firms focus on Qui Tam. Over the past several years, there has been a dramatic increase in the number of Qui Tam suits. As a result, there are now law firms that focus exclusively on qui tam actions. One such firm, Warren Benson Law Group, states on its website, www.warrenbensonlaw.com/medicare-fraud.com:

In recent years, Medicare fraud and Medicaid fraud have been the two most active areas of qui tam litigation, outnumbering qui tam cases involving defense contractor fraud. It is estimated that Medicare fraud and other fraud cost the federal government billions of dollars each year.

There are numerous frauds Medicare and other healthcare providers and companies have devised to cheat the Government…[such as:]

- Services not rendered
- Upcoding schemes and Unbundling
- Kickbacks and Self Referrals
- Falsely Certifying and Giving False Information
- Lack of Medical Necessity
- Fraudulent Cost Reports
- Grant or Research Fraud

These firms generally take qui tam cases on a contingency fee basis, making it enticing for potential relators to come forward and initiate litigation against the alleged wrong-doers.

10. Broad provider responsibility – Scope of liability. In the face of the increasing scrutiny of claims and the relatively new era of Recovery Audit Contractors, parties should understand the broad scope of what can be considered a false claim and their obligations to properly bill for services. A good discussion of the breadth of the provider’s responsibility is set forth in an article by Charlie Artz, a well-regarded healthcare attorney. See False Claims Act Implications in Physician’s News Digest www.physiciansnews.com/law/805artz.html. A few of the key concepts discussed by Mr. Artz are excerpted below:

In Re: Cardiac Devices Qui Tam Litigation, the U.S. District Court in Connecticut refused to dismiss a whistleblower’s case against health care providers who submitted claims for services that were not covered by Medicare, held that the health care providers had a duty to familiarize themselves with all requirements for reimbursement, and allowed the False Claims Act case to proceed exposing the health care providers to millions of dollars in refunds and civil fines.

Although the opinion was close to 100 pages in length, the key facts can be summarized as follows. Then-HCFA published a manual over 1,000 pages in length containing literally hundreds of reimbursement rules and requirements. These billing guidelines were not statutes passed by Congress after the people had an opportunity to debate them. These were not regulations published with notice and comment by the general public or the health care community to make improvements or to object to certain clauses. These were purely interpretive guidelines published by the federal government. One of those several hundred billing guidelines contained a provision prohibiting reimbursement for any non-FDA approved device or service. The 40 hospital defendants in this massive federal court litigation submitted claims to Medicare and received payment for services provided to patients who participated in clinical trials involving several different investigational cardiac devices that had not been approved for marketing by the FDA.
One clause in the hospital payment manual stated that medical devices not approved for marketing by FDA are considered investigational by Medicare and are not reasonable and necessary for the diagnosis and treatment of illness or injury under the Medicare statutory definition of medical necessity. Apparently, the hospitals billed these services by mistake, believing that since the clinical trial was approved, the provider was allowed to bill Medicare for the device and related services.

A whistleblower realized many hospitals were billing Medicare for non-FDA approved cardiac devices and filed a civil false claims case in federal court. The federal government intervened and is now prosecuting the False Claims Act case against hospitals. The hospitals asked the federal court to dismiss the case for several reasons. One of the key defenses is that a simple violation of a statute or regulation does not, by itself, trigger False Claims Act liability. The federal court rejected that analysis and made the following key points that should guide your compliance efforts.
11. Heightened regulatory and enforcement environment – False Claims Act and Anti-kickback Statute. The government has looked to regulatory mechanisms like the False Claims Act to recover money spent improperly as a politically palatable way to attack healthcare providers and healthcare costs. Given the demonstrated success of this strategy, we expect more, not less, recovery of claims of this sort. As William Corr, Deputy Secretary of the U.S. Department of Health and Human Services, stated on October 28, 2009:
As a result of the priority given to combating health care fraud by President Obama, the government has been able to achieve a more rapid response to fraudulent schemes and increase its recovery of more funds lost to fraud than in previous years. For example, HHS Office of Inspector General investigations have resulted in $4.0 billion in receivables for FY 2009, increase from $3.2 billion in DIG investigative receivables in FY2008. Strike force cases typically are indicted and litigated faster than traditional criminal health care fraud cases.

Since March 2007 strike force cases that included HHS agents have obtained 189 convictions, 443 indictments, and total an estimated $227 million in expected recoveries. During this time, the Department of Justice also secured the largest health care fraud settlement in history against a pharmaceutical company for Medicare and Medicaid fraud and for violating the Food, Drug and Cosmetic Act. I refer to the $2.3 billion settlement with Pfizer to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products.

Mortality, costs higher for women with cardiovascular disease

HEART DISEASE SHOULD top the list of women’s health concerns. Women disproportionately fear dying from breast cancer compared to heart disease, dutifully scheduling annual mammography, oblivious to their cardiovascular risks. There is little demand by women and the medical community for an urgent agenda or a “march for the cure” for heart disease in women.

Cardiovascular disease (CVD) is the single most common cause of death in women and men. Despite widespread assumptions to the contrary, women have accounted for more than one-half of the almost 1 million deaths due to heart disease and stroke in the United States annually since 1984. Women, compared to men, especially those under the age of 50 years, experience higher rates of recurrent myocardial infarction, heart failure and mortality after a first myocardial infarction, and are more likely to be misdiagnosed or diagnosed late in the course of their illness.

Annual hospitalizations and mortality for heart failure and total CVD expenditures are greater for women than men. While mortality from cardiovascular diseases has significantly declined over the past three decades, women have not experienced the same reductions in death and disability as have men. This significant gender-related mortality gap persists due to a combination of low awareness, misconceptions by physicians and women, gender-based physiologic differences, and disparities in care.

While these data might initially appear discouraging, improving these measures represents a significant opportunity to improve women’s CVD outcomes as well reduce overall healthcare expenditures by providing optimal screening and preventive services, appropriate and accurate diagnostic tests and timely cardiac care.

LESS THERAPY FOR WOMEN

The underlying causes for these disparities are multifactorial and the solutions complex. Gender-based disparities in preventive, diagnostic and therapeutic interventions are present on multiple levels. Women receive fewer cardiac diagnostic evaluations and less intensive therapy, from preventive interventions, to revascularization procedures to aspirin prescriptions. Even after a diagnosis of heart disease, gender-based differences in provision of care are present.

Women hospitalized with myocardial infarction are more likely than men to be managed by generalists, rather than referred for cardiology consultation, and are less likely to be transferred from community hospitals to centers for advanced care—practices associated with poorer short-term outcomes.

Additionally, societal and individual misconceptions about cardiovascular risk and what a heart patient “looks like,” along with inadequate gender-specific research data on cardiovascular disease and risk factors, contribute to lower awareness and poorer outcomes. While women’s symptoms can sometimes be challenging to address, both women and their physicians can be too quick to attribute potential manifestations of cardiac disease to menopause or aging. It is important to counteract the widely held belief that women do not develop heart disease except at advanced ages by raising physicians’ “index of suspicion” for cardiovascular disease in women.

There is also a growing body of literature documenting important biologic gender differences in CVD that may impact clinical care delivery. There are obvious differences due to the effects of gonadal hormones. However, differences in symptoms, accuracy of diagnostic tests, response to therapy, prevalence and relative risk of cardiovascular risk factors, as well as social and behavioral issues have all been identified. It is not always apparent whether or not these differences warrant a variation in established practice.

Many early cardiovascular clinical trials routinely exclude women or make no effort to enroll women in sufficient numbers to draw gender-based conclusions. With few exceptions, women currently make up only 20% to 30% of participants in cardiovascular clinical trials. Even when women are included as research subjects, it is often difficult to determine their outcomes from published reports. Only a quarter of recent cardiovascular trial results published in major U.S. internal medicine and cardiology journals reported gender-specific outcomes.

The lack of relevant research in women has resulted in a substantial and persistent gender-based knowledge gap about everything from the symptoms of heart attack in women, to the risks and benefits of commonly used cardiovascular diagnostic tests and therapies. Better evidence from properly designed research studies can better serve women with CVD.

An important example is the National Heart, Lung and Blood Institute (NHLBI)-funded multi-center Women’s Ischemic Syndrome Evaluation (WISE) study of approximately 900 women who underwent coronary angiography for chest pain symptoms and a multitude of other investigations designed to better characterize ischemic heart disease in women. We have already learned a great deal from numerous WISE publications that have underscored the value of gender-specific research and fundamentally changed the understanding of chest pain, CVD risk factors, vascular function, hormone interactions and atherosclerosis in women.

Cardiovascular clinical trial design must include women in adequate numbers to provide gender-specific data, and that data must be analyzed and reported by gender.

Systemic contributions to differences in cardiovascular care for women also include physician practice and referral patterns. In the United States, many women receive all or most of their medical care from specialists in obstetrics and gynecology during their reproductive years and continue those relationships well past menopause, or until a significant non-gynecologic illness occurs. Traditionally, there has been a greater focus on reproductive and breast health than on other health risks, and less awareness and self efficacy among these specialists about early cardiovascular risk identification and treatment.

RISK FACTORS ON THE RISE

The rise in risk factor prevalence in younger women, especially smoking, obesity and diabetes, has led to a growing number of individuals at high risk who do not look like typical heart patients. Reducing women’s future burden of CVD will depend heavily on improved preventive measures which currently fall short of recommendations. Simply taking what has been proven effective, and widely and appropriately applying it to women, can markedly improve care and outcomes.

Critical to this effort is continued education about women’s cardiovascular risks, symptoms and the use of appropriate diagnostic tests and therapies.

The most recent guideline, published in 2007 by the American Heart Assn. and endorsed by multiple professional and patient organizations, has simplified the risk assessment and decision-making process for easier implementation in daily practice.

The guidelines encourage clinicians and patients to focus on reducing long-term, rather than 10-year CVD risk. With few exceptions, those therapies that have been shown efficacious in men also prevent CVD in women and should be recommended to women at risk.

Sharonne Hayes, MD, FACC, is the director of the Mayo Clinic Women’s Heart Clinic and associate professor of medicine for the Mayo Clinic College of Medicine.

7 Technology and Development Concerns for GI in ASCs

GI and endoscopy are high-volume, profitable procedures for ASCs and are dependent on advancements in technology and solid business strategies from start-up on. Here are seven important concepts about technology and development you should know for a successful GI-driven ASC.

Technology
1. Virtual colonoscopy remains a hot topic. Although virtual colonoscopy, or computed tomography colonoscopy, is currently not covered in the ASC setting, it still remains a controversial and much discussed topic for gastroenterology in ASCs.

Virtual colonoscopy is a non-invasive diagnostic tool used to detect polyps, which could be cancerous. Proponents have touted its use because it is a more comfortable, less anxiety-causing alternative to traditional colonoscopy, which may encourage more patients to undergo screening for colon cancer.

However, if a polyp is detected, patients must then undergo a traditional diagnostic colonoscopy, which is one of the reasons it is not covered by most payors.

“Virtual colonoscopy is an excellent imaging tool,” says Dr. Sears. “It is less invasive and has a lower rate of complications but it has a number of significant limitations which will likely limit its use. It requires a full bowel prep and is a painful procedure as air is inflated in the colon and sedation is not administered (as it is during a colonoscopy).” 

He also notes some other limitations. “It is unreliable for small polyps which can represent 80 percent of polyps seen in the colon,” Dr. Sears says. “It has a high radiation exposure equivalent to 250 chest X-rays. Because of these limitations, the U.S. Preventive Task Force did not endorse it as a primary colon cancer screening tool. I do not feel it will impact screening colonoscopies, but it does offer an alternative to a barium enema in the event of an incomplete colonoscopy.”

Dr. Bermudez agrees that virtual colonoscopy won’t surpass traditional colonoscopies. “I believe the main role [of virtual colonoscopy] will be in screening average risk patients. It is possible that it will decrease the number of [traditional] colonoscopies in this group of patients. On the other hand, virtual colonoscopy will identify a number of lesions (real and not real) that will require diagnostic colonoscopies, increasing the demand for diagnostic colonoscopy,” he says.

Mr. Tanner notes, “If and when it does get CMS approval, I believe that if the technology reached some percentage of the population that is eligible for screening but will not get screened due to fear of the invasive nature of the colonoscopy, then it will be good for patient care and will have limited impact upon GI ASC patient volumes.” 

2. Capsule endoscopy’s impact on ASCs is not yet known. Capsule endoscopy, in which a patient swallows a small capsule camera that downloads digital images of the small intestine for diagnosis, is still in early phases of development. Therefore, its impact on ASCs and tradition colonoscopy is still relatively unknown.

Dr. Bermudez notes that questions regarding the device’s sensitivity and cost need to be answered before it is considered a serious alternative to colonoscopy.

Mr. Tanner also does not think it will highly impact GI in ASCs. “Capsule endoscopy is not an approved ASC procedure, and currently it is primarily used for small bowel diagnostics. In that regard it is completely different from colonoscopy and non-threatening,” he says.

3. Other new technologies are on the horizon, but may not improve on traditional colonoscopy. Endoscopy, like other medical fields, lends itself to new innovations such as chromoendoscopy, endo-capusle for colon examinations, third-eye endoscopy and narrow-band endoscopy. However, the new technology is only as effective as other non-technological procedures essential for clear screenings.

Dr. Bermudez says of new technologies, “Some of these techniques may have a significant cost that may not be justified by the potential benefits. I think that there are techniques that can significantly impact the quality of care at no cost, such as the quality of prep for colonoscopy, withdrawal time, polyp detection rate and adequate follow-up colonoscopies if polyps have been found.”

Development
1. Make sure you leave room to grow when building a new center. While you don’t want to overbuild, you should leave room for growth within the plans for a new GI-driven ASC. Not only will this help your center prepare for an increasing case load brought in by new physicians, it will also make your center more appealing to corporate partners if you end up looking for a partnership down the road.

“Most physicians start with two or three rooms in their center. A successful outpatient center lends itself to more patients, and, over time, the center will be more attractive to physician users,” says Mr. Vick. “I usually advise physicians to add one more room than they think they will need because, in the end, they will need it.”

According to Mr. Vick, one area corporate partners look at when deciding whether or not to partner with a GI center is capacity for growth. “A center won’t be worth much to a corporate partner if there is no room for growth of the business or expansion of the facility,” he says.

2. Be prepared to research corporate partners. With the right corporate partner, GI centers can see their revenue and profits increase substantially, according to Mr. Vick. The table demonstrates how one physician-managed GI endoscopy center Mr. Vick worked with improved its earnings and profits after partnering with the right management company.

	Dec. 2008	Sept. 2009	Change
	12 mo. before	12 mo. after
Net revenue	$3,030	$3,520	+16%
Net income	$780	$1,090	+40%
EBITDA	$811	$1,131	+39%
% EBITDA	27%	32%	+19%
Net revenue/case	$512	$672	+31%
EBITDA/case	$137	$216	+58%

GI centers should take the time to research and perform due diligence when exploring partnerships with a management company. Mr. Vick suggests looking at several companies’ track records with regards to same store growth, management services provided and satisfied physician-partners.

“The physician-owners need to see if a company 1) pays a fair market multiple, 2) helps their centers grow and 3) helps the physicians’ distributions to increase,” Mr. Vick says. “Ask for a wide range of references from the potential partner’s centers. The company should be willing to provide a list of all of their centers rather than cherry picking the best. I’ve received a lot of phone calls from unhappy physicians who didn’t take these steps.” 

3. The right corporate partner is not necessarily the one that offers the most money. Even if a GI center thoroughly researches corporate partners, many may be tempted to say yes to the one that offers the most money up front. However, it can be more advantageous to look at the long-term track record prior to signing an agreement.

“A company may offer a lower upfront multiple that is still competitive, but if they have a good track record, physicians may see a bigger increase in future distributions than may have occurred with a company with poorer management services but offering a higher upfront multiple,” Mr. Vick says.

Another partnership arrangement an ASC can consider is bringing in a corporate partner to purchase a minority interest during the ramp-up phase of the center. “GI centers almost always increase in value in the first few years, and you [and the current partner] can look for a majority partner once the center matures and see a much higher return on investment,” Mr. Vick says. 

4. Joint ventures with hospitals can be beneficial if the terms are right. Many GI centers look to local hospitals to help with the management of the center and to take advantage of hospital contracts and relationships with local physicians. However, like with corporate partners, GI centers should ensure that an agreement with a hospital is what is best for both partners. 

Mr. Tanner says that the benefits of a hospital partner depend upon what the hospital can add to the economic success of the joint venture. “Contributing factors to consider are 1) does the hospital own or control any group of patients or payors that the ASC would not be able to contract with absent the hospital’s participation; 2) can the hospital improve upon third-party reimbursement and to what degree; 3) can the hospital add long-term security by being a partner as opposed to an adversary; 4) can the hospital purchasing power be leveraged to secure better cost for equipment and/or supplies; and 5) if the physicians are a coalition versus a single group, does the hospital benefit substantially from providing ancillary services such as pathology or even anesthesia,” Mr. Tanner says.

Mr. Vick recommends ASCs consider bringing in a third-party management company if partnering with a hospital to make sure that the GI center continues to be operated efficiently and economically under the new ownership structure. “Most hospitals want to own 51 percent of the venture, but they don’t know how to manage GI centers,” he says. “Often, hospitals won’t offer as a good purchase price and often overburden the business with overhead costs, and the efficiency and economics of the center can suffer.”

13 Reimbursement and Business Concepts You Should Know About GI in ASCs

GI and endoscopy continue to be profitable specialties for ASCs in spite of some declines in reimbursement. Here are 13 important reimbursement, business and physician concepts you should know for your ASC.

Reimbursement
1. Reimbursement for GI centers will continue to decrease. As has been the case for the last few years, reimbursements for GI procedures have decreased across the board. This has hit ASCs especially hard as surgery centers often receive reimbursement at a percentage of hospital outpatient departments.

“We anticipate that CMS will continue to pressure facility fees in a downward fashion,” says Barry Tanner, president and CEO of Physicians Endoscopy. “It is at least conceivable that freestanding ASCs could get rates at 50 percent of HOPD rates in the next four to five years.” 

With CMS setting lower rates, a problematic trend could be seen across private insurers and third-party payors as their rates are often set relative to what CMS pays for Medicare-covered procedures. As a result, gastroenterologists and GI-driven ASCs must continue to run their centers efficiently and economically.

“Unfortunately, reimbursements are likely to steadily decline over the next few years,” says Stephen Sears, MD, a gastroenterologist in Loveland, Colo. “This effect will cause ASCs to become more efficient or to stop operating. This may also drive more cases into the hospital setting. By doing so the procedural cost will double and in the end healthcare costs will increase. To remain profitable, the GI physician must focus on delivering quality care in the most efficient manner. That can be done with better bowel preps, training, state of the art technology and assessing quality measures.”

One consequence of decreasing GI reimbursements may be a reduction in the number of Medicare patients a GI ASC sees in a year, according to Fernando Bermudez, MD, medical director, and Beth Miller, administrator, of Eastside Endoscopy Center in Saint Clair Shores, Mich.

“Unless Congress changes the existing rules, Medicare will reduce the professional fees for procedures by 20 percent in 2010,” Dr. Bermudez says. “This won’t directly affect ASCs, but it may affect the willingness of gastroenterologists to perform endoscopies on Medicare patients and to do procedures on Medicare patients in the ASC setting.” 

Irving Pike, MD, president of Gastroenterology Consultants in Virginia Beach, Va., has seen some ways in which physicians at ASCs have tried to combat declines in reimbursement. “Several ambulatory endoscopy centers have reported to me that they have recently negotiated an increased fee schedule from non-government insurance companies. In the past when Medicare payments to facilities were decreased, insurance companies did not follow with similar cuts, but ASC fee schedules remain substantially below HOPD fee schedules. In my opinion, insurance companies do not want to discourage physicians performing endoscopy in ASCs. I think at some point it may be plausible for ASCs to move more CMS cases to the hospital and fill the slots opened at the ASC with patients covered by non-government insured patients,” he says.

2. Gaining access to HOPD rates alone is not reason enough to partner with a hospital. Although partnering with a hospital in order to gain access to outpatient department reimbursement rates can be a potentially attractive strategy, GI-driven ASCs should be aware that they may not receive access to full HOPD rates, although they may be better than current reimbursements. Since many hospitals want to own 100 percent of the GI center, physicians may be asked to give up your ownership and access to future distributions.

“HOPD rates can increase GI center facility revenue 35-40 percent for non-Medicare patients,” says Jon Vick, president of ASCs Inc.. 

“If the GI physicians are going to be owners, then the expectation of getting HOPD rates is misplaced,” Mr. Tanner says. “Better rates may be possible, but HOPD rates are highly unlikely.”

In some cases the hospital and an ASC management development company may form a joint venture that then purchases a 51 percent interest in the center, according to Mr. Vick. “I suggest partnering with a management company first and letting the company negotiate with the hospital as the hospital partner will want to control the deal,” he says. “The management company would then work on the side of the physicians and ensure that the hospital doesn’t ’steamroll’ the physicians into accepting less than the center is worth. Additionally, with the ASC management company managing the center it will retain it efficiencies and economies.” 

It is important to remember when considering this arrangement that even if a physician-owned ASC partners with a hospital, it is still a freestanding ASC and it does not become an HOPD nor does it share in the HOPD reimbursement rates, according to Rick Jacques, president and CEO of Covenant Surgical Partners. “Sometimes, however, a hospital may have such good contracts with third-party payors that a partnership with the hospital would increase the reimbursement rates with payors other than Medicare,” he says.

3. Declining pay may force GI physicians to seek new revenue opportunities. The proposed 21.5 percent cut in the physician fee schedule for specialists, including gastroenterologists, coupled with decreasing reimbursements for GI procedures, may encourage GI physicians to consider additional revenue streams.

“We believe that professional fees will continue to be pressured downward, and GI physicians will be forced to resign themselves to reduced income or to capture a portion of the technical fees,” Mr. Tanner says. “Those GI physicians that have not yet captured a portion of the technical fees through ASC ownership are increasingly under pressure to do so by forming coalitions, mergers with larger groups, etc.” 

General business concerns
1. Good case volume depends on the market. While there is no definitive average number of cases GI centers should see to remain profitable, most GI ASCs have a good referral base from which they can pull patients. However, there are some figures to keep in mind to help you determine if your center is on target.

“The key is to maximize utilization of each available procedure room,” Mr. Tanner says. “There is an average of 251 operating days per year, and full utilization for a GI procedure room operating eight hours each day would be approximately 16 cases per day (30 minute time slots per case) or roughly 4,016 annual cases. Sixteen cases per day is rarely achieved due to cancellations, no shows, etc. However aiming for 80 percent utilization is certainly reasonable (around 3,200 cases annually). Achieving that sort of utilization per room, and assuming that the ASC is not overbuilt, should result in a successful GI ASC.” 

Dr. Sears notes that physicians at the ASC where he practices average 12 procedures per day, or one every 30 minutes.

Mr. Jacques agrees that around 3,000 annual cases can lead to a successful center. “Most physicians [who use GI ASCs] have well-established practices, and it is very unlikely that those cases will go away. The key is keeping your relationships within the community strong,” he says.

2. Some GI centers have benefited from providing anesthesia. In the past, most GI procedures were performed under conscious sedation, which the gastroenterologist administered prior to the procedure, according to Mr. Jacques. Since the patient was not fully sedated, monitoring by an anesthesiologist was not necessary. However, over the past decade, the trend with GI procedures has moved toward monitored anesthesia, using drugs such as propofol, which must be administered by an anesthesiologist or CRNA. 

“I believe that monitored anesthesia care is fast becoming the standard of care,” Mr. Jacques says. “Patients who are under monitored anesthesia often allow physicians to provide a more successful colonoscopy, because they are more comfortable. Under conscious sedation, although the patient may not remember the procedure, they are still awake and uncomfortable, which may cause them to react and compromise how well the colonoscopy is performed.”

Mr. Jacques notes that centers have three options to keep them in compliance with what states mandate regarding anesthesia administration: 1) the physicians who own the ASC arrange to ‘employ’ an anesthesiologist or anesthetist who provides anesthesia through their private practice, 2) the ASC employs its own anesthesiologist or 3) the ASC contracts with an independent anesthesiology practice. 

However, anesthesia is not covered for many GI procedures, so some gastroenterologists have benefited by directing the administration by propofol. Mr. Tanner cautions that if physicians choose to do this, they must be aware of the regulations in their area regarding anesthesia administration.

Dr. Pike also notes a trend towards anesthesia in GI procedures but cautions that colonoscopies performed while the patient is under propofol have not been indicated for use by many gastroenterology societies. 

“It is true some ASCs have turned to various models of anesthesia as an additional source of revenue,” he says. “I have seen information estimating that currently 40 percent of GI endoscopy is performed with deep sedation involving propofol. One concern I have about this practice is that as the total cost of GI endoscopy increases due to the additional cost of providing anesthesia [and] the payment for both the professional fee for the endoscopy and anesthesia will be cut to control overall cost to insurers. It should be noted that the three GI societies have jointly written a letter indicating the opinion deep sedation with propofol administered by anesthesiologists or CRNAs is not warranted for standard GI endoscopic procedures.”

3. Beware of potential kickback scenarios with contract anesthesia companies. As more GI centers consider providing anesthesia services, they may look to an outside company to assist them with the process. Mr. Jacques warns that some companies may enter into joint ventures with GI centers in ways that “push the envelope” with regard to the law.

“Some companies have been extremely aggressive when approaching gastroenterologists about these joint ventures,” he says. “We’ve seen gastroenterologists approached at a much higher rate over the past 1.5 years. Some scenarios have the company essentially providing kickbacks to the gastroenterologists for the contract to provide anesthesiology services to the center. The government is now looking very hard at these ‘pay for play’ arrangements.” 

Procedures and gastroenterologist issues
1. The number of procedures performed per endoscopy case can lead to lower reimbursements for secondary procedures. According to Mr. Tanner, the typical number of procedures per endoscopy case is 1.10-1.20. Many payors, including Medicare, often reimburse any secondary procedures at a much lower rate, which can affect revenue and efficiency in the ASC.

“The number of procedures per case impacts upon revenue per case because for many payors, the second and third procedures are reimbursed at half and then 25 percent of the first procedure,” Mr. Tanner says. “Therefore, valuable procedure room time is being utilized at an ever decreasing rate. If the facility is essentially fully utilized, the impact is not as strong; however, if an ASC is struggling with utilization, then it may not be profitable to perform these secondary procedures at one time.” 

2. Payment data for some of the most common procedures in GI ASCs. Here are 2008 CMS payment data for some of the most commonly performed GI procedures in ASCs.

Upper stomach-intestine scope for biopsy (CPT 43239)

• average submitted charge: $1,451
• average allowed charge $408
• average payment: $321

Scope of colon for diagnosis (CPT 45378)

• average submitted charge: $1,502
• average allowed charge: $422
• average payment: $330

Scope of colon with biopsy (CPT 45380)

• average submitted charge: $1,549
• average allowed charge: $406
• average payment: $318

3. With the number of certified gastroenterologists decreasing, it is important to focus on recruiting. As with many medical professionals, the number of practicing gastroenterologists is decreasing as physicians retire or leave practice, and the number of GI physicians coming out of medical school is not enough to sustain the rate of departing physicians. A recent New York Times report indicated an additional 1,050 GI physicians is needed by 2020 to meet the demand, with current employment around 10,390 as reported in the Times. According to Mr. Tanner, around 20 percent (2,000-2,500) of practicing GI physicians are at or close to retirement, and only 300 GI fellows graduate each year. Thus, competition for new, talented GI physicians is high.

“Recruiting new physicians is difficult especially because there is such a demand for their services,” Mr. Tanner says. “They can literally pick a place on the map where they want to work and go there with near certainty of getting a good job. This makes it more difficult for smaller, more out of the mainstream communities to find and recruit GI physicians. Many physicians graduating today are seeking a better quality of life, and, for them, the employment model is a better option.”

Although the outlook for recruiting new physicians may seem grim, Mr. Tanner notes some new physicians may be looking for options outside of the employment model. “There are still many entrepreneurial physicians not seeking employment, but they are looking for ownership in an ASC knowing that the ASC will be responsible for a significant portion of their total medical practice income,” he says.

4. Single-specialty GI ASCs have a lot to offer gastroenterologists. Although some concern has been raised by the trend of many specialists and practices seeking employment with local hospitals, single-specialty GI ASCs offer gastroenterologists an additional source of income and autonomy that may not be available through the hospital. As a result, ASCs should demonstrate the potential benefits of ASC ownership to physicians looking to partner with the center.

“Many GI physicians who have ownership in a single-specialty ASC earn a substantial amount of ancillary income from their ASC ownership, sometimes as much as they earn from their professional fees,” Mr. Jacques says. “A single-specialty ASC is an excellent recruiting tool for practices, because it gives the practice the ability to offer new physicians ownership in the center. A hospital trying to recruit physicians to their [facility] might not be able to offer the new physician the same ancillary income potential an independently-owned, single-specialty ASC can. Typically, once a hospital buys a physician practice and ASC, the physician income decreases substantially.” 

Dr. Sears notes that some GI specialists may turn to the hospital to avoid feeling the financial hit of reduced reimbursements, but that reason alone is not enough for all GI physicians to turn away from private practice and ASCs. “I feel that remaining as a private practitioner, I have more to offer than as a salaried hospital employee,” he says. “In order to keep the edge on the hospitals, we will need to focus on an equivalent or better product for the same cost. Patients will be able to see what procedures cost at different facilities and in the future may refuse to be treated in the hospital setting due to the additional charges.”

5. Although GI physicians aren’t running to the hospitals, primary care physicians are. Primary care physicians, who refer cases to gastroenterologists, are increasingly employed by hospitals. As a result, GI centers and their physicians should develop a positive relationship with hospitals.

“We have seen a significant number of PCPs employed by the hospitals,” says Dr. Bermudez. “This gives the hospitals significant leverage in the referral pattern to specialists, and it is very important that specialists, including gastroenterologists, maintain a good relationship with the hospital and work more like a partner than a competitor.”

6. Surgery centers should look to grow their referral base. When it comes to recruiting new physicians to your surgery center, looking within the local community still remains one of the best tactics. According to Mr. Jacques, there are probably unaffiliated physicians nearby who would jump at the opportunity to invest and perform cases at a single-specialty center, if approached properly and given a fair proposal.

“In order to grow, you also need to expand your referral base,” Mr. Jacques says. “Look into the areas of the community that are not getting screened for colon cancer. The same tried and true techniques that have worked in building a physician’s practice are still successful. Make sure you are consistently making call backs and follow-ups to local referring physicians.”

7. Salary information for gastroenterologists. In respect to other surgical and medical specialties, salaries for gastroenterologists have increased at an average rate. For example, the median salary in 2008 was $389,385, up 3.93 percent from 2007, compared with a 6.58 percent increase for ophthalmologists and a 5.80 percent for orthopedic surgeons over the same period, according to data from the American Medical Group Association’s 2009 Medical Group Compensation and Financial Survey. The average starting salary for GI physicians was $275,000, according to the same report.

Here are regional median salaries for gastroenterologists, according to the AMGA:

• East — $401,615
• West — $385,611
• South — $385,542
• North — $394,417

7 Rules for Medical Direction of Nurse Anesthetists

Medicare pays physicians for medical direction of nurse anesthetists at 50 percent of the reimbursement they would receive if they performed the work alone. CMS says physicians will be paid for medical direction of two to four concurrent cases provided they:

1. Perform a pre-anesthetic examination and evaluation and document it in the medical record.
2. Prescribe the anesthesia plan.
3. Personally participate in the most demanding procedures in the anesthesia plan —including induction and emergence, if applicable — and document this.
4. Ensure that any procedures in the anesthesia plan are performed by a qualified anesthetist.
5. Monitor the course of anesthesia administration at frequent intervals and document that they were present during some portion of the anesthesia monitoring.
6. Remain physically present and available for immediate diagnosis and treatment of emergencies.
7. Provide indicated-post-anesthesia care and document it.

Source: CMS

Successful Appeals of Denied Claims

It is annoying and very time-consuming, but it is very important to appeal denied claims. Insurance companies count on providers not pursuing appeals — only 35 percent of providers do. Yet, many times appeals can be successful, so they’re worth the time. They are also a valuable tool for determining what needs improvement in the business office.

Common reasons for Medicare claim rejections
When auditing watch for errors payers find easy reasons to deny claims:

• Patient ID/subscriber number is incorrect, missing or placed in the wrong claim field.
• Provider’s signature on the claim is missing.
• Date of Service or required dates are missing or incorrect on claim.
• Diagnosis code is invalid, lacks specificity, does not correspond with or does not support the procedure(s) billed.
• Procedure codes used on claims are missing, incorrect or unlisted CPT codes were used, without justification/explanation given.
• Provider’s fee on the claim is blank.
• The referring/ordering physician’s name and/or NPI number are missing from the claim.
• Sending in another claim on a previously-filed claim (duplicate claims).
• Claims not being filed in a timely manner (within 12 months for traditional Medicare – Medicare HMO plans have tighter timelines).
• Provider tax ID number missing or incorrect.

Billing tips

• Review explanation of benefits/remittance advice for denial reasons revealing problems with insurance verification, coding and the billing at your facility.
• Carefully check Medicare Bulletins monthly for changes to existing policies and new policies (local coverage determinations) for procedures performed in your ASC, which list covered diagnoses and must be followed carefully.
• When physicians list codes on operating reports, coders should still review the entire report to confirm the codes given are correct.
• Check every field on a claim to assure they are completed properly prior to transmitting the claim electronically or submitting it via paper.
• Make sure insurance and demographic information on patients is correct. Perform thorough insurance verifications and check on pre-certifications for every case performed.
• To avoid duplicate claim denials, do not submit another claim for the same services if previously submitted without checking the first claim’s status with the payor.

If claims are subject to a post-payment audit, expedite the process by responding to these audits as follows:

• Submit all records requested promptly.
• If operative reports or pathology results are requested, be sure the lesion or pathology in question is easily identifiable.
• Submit only records for the case in question and don’t send any non-relevant records.

Appeals of denied claims
Appeals of denied claims are always an unwelcome challenge. When claims are denied, we encourage vigorous appeals. Insurance companies are banking on stringing things out and making the “hassle factor” so high that you will give up. All payors have appeal processes, which differ based on the payor and are outlined in the payor’s provider manual. These must be followed closely. If your facility does not have a contract with the payor and your claim is denied, your appeal rights are more restricted.

Medicare’s appeal process has five levels:
1. Redetermination
2. Reconsideration by Qualified Independent Contractor (QIC)
3. Administrative Law Judge hearings
4. Departmental Appeals Board/Appeals Council reviews
5. U.S. District Court review

It is very important to include additional documentation to support your position when moving to a higher level of appeal. Get the surgeon to help by writing a medical necessity letter.

Medicare says that 85 percent of claims denied for Medical Necessity reasons are denied because of the diagnosis code billed. For Medicare claims, check to see if there is an LCD policy for the procedure listing the diagnosis codes allowed. If there is not a covered diagnosis on the operative report, consult the pathology report or H&P. If the denial reason involves the ASC’s procedure coding not matching the physician’s codes, do some research and see if your coding was correct. If it is obvious that the physician coded the claim incorrectly and you feel your coding is correct, pursue appeals based on your correct coding. Do not follow the physician’s coding if you know it is incorrect.

Ms. Ellis ( sellis@ellismedical.com ) is president of Ellis Medical Consulting, a healthcare consulting firm providing chart audits for coding and documentation issues, business office operational assessments, research of coverage issues, fee and coding revisions, litigation support, reimbursement research, coding/billing training, and the development and implementation of billing compliance programs for healthcare providers.

OR Technology: A Glimpse Into The Future

As we move into 2010, a new wave of technology awaits us. Highly-developed health information technology (HIT)-driven systems and equipment are becoming the standard in many operating rooms (ORs), whether they are in a single-specialty ambulatory surgery centers (ASCs) or advanced surgical hospitals. It is important to stay up-to-date on these new technologies which not only reduce medical errors, but improve patient comfort and post discharge follow-up. The following case studies highlight this trend.

Enhancing Communication, Collaboration and Education: An Olympus Case Study

Three years after adopting integrated ENDOALPHA ORs, Penn State Hershey Medical Center is ready for more. As the only teaching hospital in central Pennsylvania, Penn State Milton S. Hershey Medical Center is one of the area’s largest healthcare providers. The hospital is equipped with 23 surgical suites and its department of surgery performs more than 19,000 procedures annually.

Staying Ahead of the Technology Curve

As industry trends move toward minimally invasive techniques, the hospital was quick to understand the benefits of integrated surgical suites as a way to stay competitive with the specialized technology demands of increasingly sophisticated procedures. “Several years ago, we realized we had a need for advanced, integrated technologies in our OR as we anticipated the convergence of laparoscopic and flexible endoscopic instrumentation,” says Randy Haluck, MD, professor of surgery and division chief for minimally invasive surgery and bariatrics. “We also recognized the need for a sophisticated system relative to data acquisition, storage, and transfer.”

Penn State Hershey began the process of integration in 2005, building three new Olympus ENDOALPHA surgical suites in 2006 and then converting two existing ORs to ENDOALPHAs the following year. The hospital anticipates completion of four more integrated ORs, for a total of 27 surgical rooms with one-third of them set up as state-of-the-art ENDOALPHAs this year.

Taking a Comprehensive Approach

True systems integration goes beyond the equipment and operating platform. It also takes into account the ergonomic design, workflow and technology optimization of each surgical suite. This means designing rooms with ceiling-mounted booms for holding imaging equipment and monitors off the floor, allowing for more efficient post-procedure clean-up and ergonomic positioning of monitors during the procedure. It means integrated equipment (scopes, imaging platforms, monitors, video and accessories) that work together and can be easily interchanged during a procedure. And it means a cohesive information management system for patient and procedural data, images, and audio that can be captured, stored, and retrieved from both inside and outside the sterile field. “We needed to have multiple surgical services using the same operating room, between general surgery, urology and minimally invasive GYN surgery,” says Gerald Harkins, MD, medical director for minimally invasive GYN surgery. “We’re all able to function in the ENDOALPHA laparoscopic suites, and it’s been a fantastic platform for that utilization.”

Experiencing the Installation Process

Olympus offers turnkey solutions, working with customers from start to finish on the design, construction and set-up of integrated operating and intervention rooms. “The flexibility of Olympus’ ENDOALPHA system means it can be easily customized to create a right-sized solution unique to each facility,” says David Alexander, Penn State Hershey’s Olympus integration consultant. “We were able to incorporate their legacy equipment along with their pre-existing video-conferencing system and streaming video package into their ENDOALPHA ORs to create one seamless solution. Hershey proved to be very knowledgeable, so it was a highly collaborative effort.”

Taking Centralized Control

The nerve center for each ENDOALPHA OR is a centralized control panel. With audio, video, data and images all controlled via a single touch screen, clinicians have the power to connect, communicate and collaborate with others outside the procedure room. Clinicians can also control surgical and room lighting, in-room observation cameras and all information and imaging systems without ever leaving the sterile field. To further enhance efficiency, the ENDOALPHA system provides preset capabilities so that monitors, lighting and all equipment can be custom-tailored to surgeon preferences and made available at the press of a button.

Communication, Collaboration, and Education

Penn State Hershey Medical Center’s custom-placed displays ensure all team members have the perfect view of live images. They regularly create video networks for sharing, collaboration and education from within and outside the hospital. “There’s no question that the Olympus system has dramatically changed how we teach in the OR,” says Peter Dillon, MD, chairman of Penn State Hershey’s surgery department and surgical director of perioperative services. “We’re now able to broadcast these procedures to first- and second-year medical students, exciting them about the wonders of surgery at a much earlier stage in their training. So it really has changed dramatically and in a very exciting fashion how we teach.” Haluck adds that it also gives the Penn State Hershey team a better way to collaborate with other physicians and share information with patients. “We can educate other physicians and record images for colleagues or bring them in when needed to confer and/or assist on a procedure. We are also able to show patients what their surgery was about and why they were having problems. That’s a great benefit to us, and certainly patients appreciate it as well.”

Interventional Radiology Breaks New Ground: A Skytron Case Study

Philips and Skytron have teamed up to help fully realize the promise of a hybrid angiography suite by implementing new cardiovascular solutions with the latest Allura Xper FD technology from Philips and state-of-the-art surgical lighting and boom technology from Skytron.

For more than a decade, Barry T. Katzen, MD, medical director of Baptist Cardiac and Vascular Institute (BCVI) in Miami, has pioneered the integration of surgical and interventional procedures. Katzen and his team continue to show that surgical procedures in an angiographic environment can be accomplished with the same degree of efficiency as in an OR.

“The specialties of interventional radiology and vascular surgery bring more to each other when we work together,” Katzen says. “Procedures that help drive this relationship include aneurysms of the thoracic aorta and abdominal aorta. Having an environment where we can use a surgical option allows us to think out of the box for individualized patient solutions.”

In 2008, Philips Healthcare and Skytron entered into a collaborative agreement to provide comprehensive, integrated solutions for the cardiovascular environment. Katzen seized the opportunity to refine the surroundings. Based on a well-coordinated plan from Philips and Skytron, a room at BCVI underwent a significant upgrade to enhance hybrid functionality.

“One of the great advantages of the new room design is it’s so spacious that we can all function effectively without being in each other’s way. Information can be transferred to the head of the bed — to the anesthesiologist — down to where we’re working very easily,” says James F. Benenati, MD, medical director of the peripheral vascular laboratory.

A Room That Works

BCVI’s surgical team appreciates the changes made. Katzen believes the upgrade has created a better environment for all involved. A recent experience demonstrated how the teams successfully combined surgical access with an interventional solution. A patient presented with critical narrowing of an artery to the brain and chest, and a narrowing of that same artery in the neck. “It was a very complex situation,” recalls Katzen, “but we combined our skills. The surgeons removed the plaque in the neck with an endarterectomy and we used that same access to go down and stent the chest.”

Installation With Minimal Impact

“We’re a busy lab and taking a room down for a period of time is always an inconvenience,” says Katzen. “The one thing everybody remarked upon was how fast this upgrade was accomplished.” In two and a half weeks, Philips and Skytron, working closely with the implementation team at BCVI, completed the staging and upgrade. The new room reflected the input of interventional radiologists, surgeons and anesthesiologists, with each group helping to define the clinical specifications to make it a multi-disciplinary environment.

OR Technology Update: A Steris Case Study

The epitome of surgical technology today is one OR in which surgeons can perform image-guided, catheter-based interventional procedures; minimally invasive endoscopic procedures; extremely precise robotic surgery; or full open surgery, depending on the case load or discoveries made in surgery. In this type of hybrid OR, integrated imaging, computerized patient information and live video routing technologies instantly display test results and critical real-time information on high-definition monitors in the sterile field. This allows surgeons and staff to ascertain the most timely and accurate diagnosis and treatment for the patient. It also helps them achieve the most flexible and effective uses of the room and optimize scheduling and utilization.

These are also the types of rooms in which medical leaders and pioneers train residents and other clinicians, develop new minimally invasive procedures, such as natural orifice trans-luminal endoscopic surgery (NOTES) and trans-catheter heart valve replacement and master new surgical devices.

These highly advanced rooms can incorporate advanced communications, connectivity, LED surgical lighting and high-definition visualization such as intra-operative fluoroscopy, intra-operative computerized tomography, magnetic resonance imaging, image-guided navigation, 3D software extrapolations of the imaging, robotics and many other technologies. Each of these tools are important in today’s hybrid OR, but when integrated correctly they form a seamless whole that is greater than the sum of its parts.

To accomplish this synergy, STERIS collaborates with leading manufacturers to design and install customized, integrated HD360°™ Hybrid ORs for healthcare facilities. STERIS project design managers configure STERIS’s open infrastructure Harmony® Lighting and Visualization systems, equipment management systems and advanced integration technologies with interoperative imaging, robotics, endoscopic and video technologies and more. The result is a suite that enables fully informed staff, highly efficient procedures, extremely flexible room use, successful surgeon recruitment, medical education, ongoing surgical innovation, leading edge robotic surgery, telemedicine, and new possibilities yet to be imagined.

OR Technology Update: A Berchtold Case Study

Problem

Before hybrid ORs existed, imaging and communications capabilities were not an option during cardiovascular and neurosurgery operations, resulting in patients getting diagnosed and treated in two different visits. Separate procedures and imaging consultation can be costlier for patients and surgeons, can result in additional stress, more down time and longer hospital stays for the patient, and are not conducive to emergencies that sometimes arise during surgery.

Solution

Combine minimally invasive and interventional surgical technologies with medical imaging and communications equipment in one operating room: the hybrid OR.

A growing trend involving endovascular procedures during cardiovascular and neurological surgeries requires equipment to accommodate open and closed procedures in the same room, even at the same time, although this is not necessarily planned from the start. The new hybrid OR model provides the surgeon flexibility in performing a variety of interventional, imaging and surgical services in one setting, eliminating the need to transfer the patient.

For example, two of the most popular hybrid ORs are for cardiovascular and neurosurgical procedures:

» Neurosurgical hybrid ORs can include magnetic resonance imaging (MRI); computed tomography (CT) and angiography equipment within a neurosurgical operating room.

»Cardiovascular hybrid ORs often features: Fixed ceiling- or floor-mounted C-arms, ultrasound and endoscopy equipment, coupled with cardiac catheter laboratories.

Because a hybrid OR is specifically designed for endovascular procedures, careful planning from the beginning can help to ensure all rooms are equipped with necessary tools. Some tips to consider while creating a specially designed hybrid OR include:

»Identify factors that are important to the hospital team, such as, should all equipment hanging from the ceiling (surgical arms, flat panel arms, etc.) be able to cover the whole patient in all orientations?

»Think as far ahead as you possibly can to “future proof” the room, reducing the need to renovate the OR moving forward. For example, what is the most extreme type of procedure the team might do in the OR? Then outfit the room in preparation for the procedure.

»Involve the end user at the very start of the project to give a real world perspective for offering scenarios, as well as discussing needs and concerns. This can include nurses, surgical technicians and staff, as well as anesthesiologists.

»Consult with the vendor providing lights, booms and imaging equipment to accommodate all of their needs. For example, many imaging companies have different requirements for ceiling heights.

Hybrid therapies enable hospitals and clinicians to provide less invasive care that is safe and cost-effective for the patient. Careful planning can lead to an effective hybrid operating room design that offers the following benefits:

» Cost-effective operations for patients and surgeons, with better outcomes.

» Reduced stress, faster recovery and reduced hospital stays for the patient.

»Safer procedures, especially in the case of an emergency.

New Bair Paws® Gown Brings “Flex Appeal” to Patient Warming: An Arizant Case Study

The recent Centers for Medicare and Medicaid Services (CMS) adoption of the SCIP-Infection-10 normothermia quality measure has made it more important than ever to simplify the process of warming every surgical patient. Arizant Healthcare’s latest innovation in forced-air warming, the Bair Paws Flex gown, does just that by incorporating a surgical warming product — Bair Hugger blankets — into a comfortable patient gown that warms before, during and after surgery.

While clinical versatility is a key benefit of the Bair Paws Flex gown, so is the practical economic approach of standardizing multiple warming capabilities into one gown that can accommodate most perioperative warming needs. While helping to improve outcomes and boosting patient satisfaction, the Bair Paws Flex gown may save facilities money by supplanting multiple OR warming blankets and the warmed cotton blankets and gowns often used to comfort patients.

Just One Gown Warms From Start to Finish

Before surgery, patients appreciate the Flex gown for its controllable warmth; they can simply dial the temperature of the air flowing through the gown to a level that’s comfortable. The surgical warming products built into the gown are unknown to the patient because they are deployed only by surgical staff.

In the operating room, the same Bair Paws Flex gown offers clinicians the ease and convenience of having multiple patient warming options available during surgery. Seamlessly integrated into the gown are: a head drape, adhesive tape to isolate the surgical field, and deployable arm extensions to transition into a Bair Hugger upper body blanket with tie strips. A second insert in the lower portion of the gown may be used to prewarm before surgery and then warm again as a lower body blanket once in the OR. The gown’s design allows upper or lower body warming for any surgical positioning — supine, prone or lateral.

After the procedure is over, the upper body blanket arm extensions, head drape and surgical tape strip perforate off, returning the garment to a standard warming gown for post-operative use through the lower warming blanket insert.

The Bair Paws Flex gown is comfortable for patients, convenient for clinicians and warms from pre-op to the OR to PACU. Best of all, it’s also economical. One gown handles almost all your warming needs, including contributing to quality goals like SCIP-10 and improved patient satisfaction. It incorporates a highly effective surgical warming device directly into a soft, comfortable hospital gown that does something positive for patients and hospital staff. It’s not just a gown. The Bair Paws Flex gown is a patient warming and patient satisfaction tool. It’s the future of patient warming, and it’s available today.

Practicing Arthroscopic Surgery on Computers, Not People: A Toltech/Sensable Case Study

Learning diagnostic knee arthroscopy is not unlike learning to play the violin — both art forms require a mixture of cognitive and proprioceptive skills that can only be developed through rigorous practice. And while both require intensive mentoring, surgical apprenticeship is unique in its resulting increase in operating room time and potentially patient risk. Just as with a violin that makes no sound, little can be learned from surrogate surgical environments having no objective feedback, including costly and labor-intensive cadaver training. And little transference of either skill can be expected from computer based training lacking the feel of the instrument(s).

In late 2009 the University of Michigan Medical Center’s Orthopaedic Surgery department, led by James Carpenter, MD, became an early adopter of the Knee Arthroscopy Surgery Trainer (KAST) from Touch of Life Technologies (ToLTech). This simulator was co-developed with the American Academy of Orthopaedic Surgeons (AAOS), Arthroscopy Association of North America (AANA), and the American Board of Orthopaedic Surgery (ABOS). It provides both cognitive and haptically-enabled skills training for the proper and efficient techniques required for diagnostic arthroscopy of the knee as done on an outpatient basis — including training to competency, and a modality for complete evaluation of residents’ skills.

In the KAST simulator, trainees hold a customized stylus in each hand — emulating the probe and camera used in actual surgery — that are attached to PHANTOM® force-feedback haptic devices, made by SensAble Technologies. The haptic devices allow trainees to navigate in true 3D space while interacting with high-resolution models that are viewed on-screen, as if through an actual arthroscope. The force feedback devices are programmed to push back on the user’s hand to deliver the “feeling” of the soft tissue, cartilage, and ligaments involved in knee arthroscopy.

The “Virtual Mentor” in KAST guides, critiques, and scores the resident on each part of the procedure. In one module, trainees must perform three steps for examining the medial meniscus with a probe. The Mentor requires the trainee to score 100 percent on each step before attempting subsequent tasks, and finally a time-trial. A special “cheater view,” only available at the novice level, shows the outside image of the knee (seen in the right hand portion of the Mentor screen), to help residents understand where the tools they are using are located with respect to the anatomy. KAST switches seamlessly between a right and a left knee, forcing the trainee to be ambidextrous with respect to the camera and probe.

Haptically-enabled surgical simulation provides cognitive and skills-based training — freeing up the outpatient facility’s attending physicians to teach higher-level skills, and giving residents unlimited autonomous practice opportunities. It allows residents’ skills to be objectively measured and validated before they undertake procedures on patients. The University of Michigan Health System’s Orthopaedic Surgery department plans trials comparing beginning residents who have trained on KAST, against a control group. Separate validation studies led by the AAOS using KAST are underway nationwide during 2010.

American Diabetes Association revises diabetes guidelines

The American Diabetes Association (ADA) has revised clinical practice recommendations for diabetes diagnosis to promote hemoglobin A1c as a faster, easier diagnostic test that could help reduce the number of undiagnosed patients and better identify patients with prediabetes. The new recommendations are published in the January supplement of Diabetes Care.

“There are several revisions and updates included in the American Diabetes Association’s 2010 Clinical Practice Recommendations that will potentially impact how health plans care for the many individuals with type 1 and type 2 diabetes and those at risk for diabetes,” says Richard M. Bergenstal, MD, president, Medicine and Science, American Diabetes Association and Executive Director, International Diabetes Center. “A significant change is that the ADA now recommends the A1C test can be used to diagnose diabetes or identify those at high risk for developing diabetes. Patients can prevent complications and suffering, and health plans can minimize long costs if diabetes is detected and treated effectively early or if diabetes can be prevented.

The A1c test, which measures average blood glucose levels for a period of up to 3 months, was previously used only to evaluate diabetic control with time. An A1c level of approximately 5% indicates the absence of diabetes, and according to the revised evidence-based guidelines, an A1c score of 5.7% to 6.4% indicates prediabetes, and an A1c level of 6.5% or higher indicates the presence of diabetes.

Extensive revisions to the section “Diabetes Self-Management Education” are based on new evidence. The goals of diabetes self-management education are to improve adherence to the standard of care, to educate patients regarding appropriate glycemic targets, and to increase the percentage of patients achieving target A1c levels.

“The 2010 Standards or Medical Care present new data to emphasize how important it is to teach diabetes self-management so health plans need to be sure they have a recognized education program in place that facilitates patient centered team care,” Bergenstal says. “There is also new evidence reviewed that will give health plans information on effective strategies to improve diabetes care and develop treatment targets in the outpatient and inpatient setting. Educating patients and providers that good diabetes care means control of blood glucose (while avoiding hypoglycemia and excessive weight gain), as well as controlling blood pressure and cholesterol is critical to preventing complications. Effective and appropriate use of new technologies like insulin pump and continuous glucose monitoring are also reviewed in light of new studies released in the last year and health plans should review this data to be able to effectively communicate with patients and providers.”

Optical technique can identify early diagnosis

An early diagnosis of common ocular diseases can be determined via an optical technique that had never before been used for this purpose, researchers from the University of Granada said. The researchers studied the image quality in subjects affected by one of two pathologies, finding a greater amount of ocular aberrations and a higher level of scattering (term associated with the dispersion that light suffers when passing through the various ocular media) in affected eyes compared with results in healthy eyes.

Age-related macular degeneration (AMD) is the leading cause of central vision loss in developed countries, and mainly affects people over 50 years of age. As far as keratitis is concerned, this condition causes inflammation of the cornea and can cause blindness, due to the severe alterations that the corneal surface may suffer.

Carolina Herrera Ortiz and colleagues measured the image quality with two optical instruments and used a psychophysical test for assessing visual performance. Results from patients with AMD were compared with those obtained from a control group of similar age without any ocular pathology. Thus, the researchers could verify that for individuals affected by this condition there is an increased level of ocular scattering that could be mainly due to the disruption suffered by the light reflected in the damaged retina of the AMD eyes, because a priori optics are not expected to be altered, since it is a retinal pathology. The studies will be published in Cornea and Journal of Modern Optics.

Researchers Find Demand for Cosmetic Procedures, Dermatologic Surgery Rising Rapidly

Physicians looking for a way to boost their revenue stream and expand their clinical expertise are turning their attention to aesthetic medicine, a field whose services span minimally invasive cosmetic procedures from peels, injections and laser services, to more invasive procedures such as plastic surgery. It’s a niche some experts believe is fairly recession-proof.

While plastic surgery has demonstrated significant sensitivity to weaknesses in the U.S. economy, according to a national procedural statistics report released this spring by the American Society of Plastic Surgeons (ASPS), minimally invasive procedures (up by 5 percent since 2007) are still popular, which confirms the so-called “Lipstick Effect” that is observed during economic downtimes; the term was coined by Leonard Lauder, chairman of Estee Lauder, who witnessed a surge in lipstick sales following the events of 9/11. Conventional wisdom tells us that during times of economic and social instability, consumers substitute small, affordable luxuries for their bigger, more expensive splurges. This concept translates to aesthetic medicine and surgical services in that patients are now foregoing or postponing pricier and more invasive procedures and opting for cheaper, less risky and more temporary fixes, such as injections and dermal fillers instead of face lifts.

This is substantiated by statistics from the American Society for Aesthetic Plastic Surgery (ASAPS), which reports that non-surgical procedures showing the most growth were laser skin resurfacing (up 12 percent), Calcium hydroxylapatite (Radwiance) injections (up 3 percent) and chemical peels (up 2.9 percent).

Cindy Graf, principal of Cindy Graf Consulting LLC, an expert in the field of aesthetic medicine practice management, and a faculty member of the IAPAM, confirms this trend. “People will always want to improve their looks to feel better about themselves” Graf says. “Another important factor that plays into this trend is gaining or keeping employment in this economic downturn. When people who are in their 40s or 50s lose their jobs, they tend to do non-surgical procedures like Botox injections or other rejuvenation procedures to make themselves more viable candidates as they try to compete in the job market.”

Physicians can make aesthetic medicine procedures attractive to patients by promoting them as rejuvenation opportunities as well as bundling procedures to improve a patient’s perception of value-added services. Equally important, these minimally-invasive procedures can offer physicians an additional cash profit center as an ancillary service to their existing ambulatory surgeries.

Graf says physicians who want to get into aesthetic medicine should proceed with optimistic caution, first ensuring that they have two very important elements in place. The first is a firm grasp on the realities of day-to-day operations. “I think that aesthetic medicine is recession-proof, but in these challenging economic times, physicians must control their overhead costs,” Graf says. “Instead of building a freestanding medical spa, I recommend that physicians add aesthetic medicine services to their existing practices first to build a clientele. One of the reasons why the medical spa industry has faltered is that a physician will spend hundreds of thousands of dollars building these places, and because of the equipment and staffing required, the high overhead becomes too much to keep up with when combined with high marketing costs. But if you go into it with a modest overhead, just adding aesthetic medicine services to your existing practice, or doing a small build-out, and then keeping costs under control, it can be a wonderful opportunity, even in this economy.”

The second key to success is having what Graf calls a “natural bridge” from an existing practice to an aesthetic medicine service line. “The physicians who are best able to cross-sell into aesthetics are those who can use this natural bridge – a common patient demographic or an existing surgical service line most complimentary to aesthetic procedures,” she explains. “For example, an OB-GYN practice has a natural bridge because the specialty already has the right patient demographic to begin with.”

Graf continues, “This field will continue to be lucrative. That’s why we continue to see interest from everyone, including core doctors such as dermatologists, as well as from physicians in other specialties because their reimbursements have been so severely cut by Medicare and insurance companies. In many practices, the costs are continuing to rise but year after year, the reimbursements are continuing to be cut, and it puts physicians in very stressful positions. Because of the nature of aesthetic medicine procedures, it’s much more pleasant and can be almost considered as a break from the stress of general medicine and surgery. So many physicians, like OB-GYNs, are getting out of their specialties because of the skyrocketing costs of malpractice insurance premiums, and they looking for a revenue stream to make up for the practices they are giving up. Aesthetic medicine can work well for emergency room physicians who work four days on and have three days off – they have long stretches of time they can devote to an aesthetic medicine practice. At my seminars I see all kinds of physicians practicing in everything from dermatology to neurology, to orthopedics; some of their nurses come with them, and I also see aestheticians who try to align themselves with a physician to launch a practice.”

With so many practitioners wanting to enter the field, could oversaturation take place? Graf doesn’t think so. “While there is some oversaturation in a few markets, I think the market has not even scratched the surface of it potential yet,” Graf says. “The numbers, even in a down economy, are continuing to grow every year and we are nowhere near saturation, so I think there is tremendous opportunity out there for the wise physician who does his or her homework and who tries to find the right bridge to aesthetic medicine. I encourage physicians to do what they enjoy, tap into the skill mix that they love, offer the kinds of aesthetic services their patients might be interested in, and then specialize in some of those procedures. Physicians shouldn’t try to do absolutely everything to compete sometimes just doing one or two procedures and doing them really well can become a great side practice.”

Graf offers what she believes are the important keys to building a successful cosmetic medicine business:

» Understand the aging face. Understanding facial structure, skin tone, skin types as well as putting together a treatment plan to address the concerns of the aging face that fits into the client’s lifestyle and budget is key.

» Hire a knowledgeable and motivated staff. Every staff member is crucial to the growth and repeat growth of your cosmetic medical business, so they should be able to discuss cosmetic procedures with clients.

» Hire a competent business manager. It should be someone in the practice who has the responsibility for setting and monitoring financial goals, marketing and hiring and training staff for the practice owner.

» Keep up with technology. Rapidly evolving technology in this field requires practitioners to stay current in their knowledge base.

» Provide ongoing training. Stay on top of the latest techniques and advancements in the industry.

» Create an effective marketing plan. Physicians must be able to let existing patients know that they now offer cosmetic procedures? Use point-of-purchase posters, brochures, samples and prescriptions to turn current patients into cosmetic clients. There are many inexpensive grassroots marketing ideas that can be initiated to cross sell cosmetic services within your social and professional areas of influence.

» Stage a seminar. Invite the public and your patients to your office for an informal presentation that includes before-and-after photos of the procedures that you are offering, demonstrate a simple procedure such as a Botox injection, and offer a specially valued package of services to those in attendance.

» Establish a physician-directed skin care program. Developing or carrying a product line is another potential profit center; product sales should be included in every consultation and treatment for higher revenue returns.

» Master the consultation process. Develop a conversational consultation style that focuses on listening to clients’ concerns, putting together a treatment plan that solves her/his concerns and then answering questions that arise. Direct the client to buy by uncovering objections of price, procedure and pain. When the package matches the list of concerns and the three P’s are answered, there is no reason not to buy.

Graf advises, “If your cosmetic medical practice is not producing the revenues that you projected in your business plan, have a hard look at the manner in which you are doing business and see if one or more of these integral keys is missing and by adding these tools, you can bring your business into the profit producing business that you desire.”

Researchers Find Demand for Cosmetic Procedures, Dermatologic Surgery Rising Rapidly

Researchers from Boston University School of Medicine (BUSM) and the Laser and Skin Cancer Center of Indiana, found that there has been a dramatic increase in the number of procedures performed and patient demand for dermatologic healthcare since 2000. The findings, which were recently reported in Dermatologic Surgery, parallels the growth in the age of individuals between the ages of 40 to 55, who make up the Baby Boomer generation.

Using data from the 2001 to 2007 American Society for Dermatologic Surgery (ASDS) member survey, the researchers found that dermatologic surgeons performed an estimated 3.4 million cosmetic and non-cosmetic surgical procedures; in 2007, it was estimated that a total of 7.6 million procedures were performed (120 percent rate of growth between 2001 and 2007). The procedures with the greatest increase during this time period were soft tissue augmentation (405 percent increase), botulinum toxin injections (324 percent increase), and non-ablative skin rejuvenation (laser, light, and radiofrequency sources) (330 percent increase). More modest increases were noted in skin cancer procedures (85 percent increase) and ablative resurfacing procedures (66 percent increase).

According to the researchers, there are two important trends fueling the growth in the number of surgical procedures performed by dermatologic surgeons. “They include the overall advancements in procedural facets of dermatology as a specialty during the last decade combined with the increased societal emphasis on skin cancer prevention and early diagnosis, as well as a desire to prevent and reverse the skin signs of aging,” says lead author Emily Tierney, MD, an assistant professor of dermatology at BUSM.

Tierney further explains, “Dermatologists have been integral to the rapid evolution of photomedicine, with the advances in laser and light devices to treat a diversity of skin conditions. These include actinic keratoses to nonmelanoma skin cancer, pigmentary and vascular disorders, hair and tattoo removal, wrinkles and other signs of photoaging. In addition, the popularity and growth in minimally invasive cosmetic procedures, including botulinum toxin injections, dermal fillers, and nonablative skin rejuvenation techniques (chemical peels and laser, light, and radiofrequency devices) have increased exponentially.”

The researchers anticipate that the role for the dermatologist in a diversity of surgical pursuits, ranging from skin cancer treatment, minimally invasive cosmetic, and laser procedures to complex cosmetic and reconstructive procedures, will continue to grow and expand and contribute to the quality and diversity of procedures performed.

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