Estimated Cost Savings and New Revenue From Installing an EHR

Based on research studies and federal funding estimates for an electronic health record system of no particular brand name, installing an EHR system can generate as much as $1.7 million per physician in cost savings or new revenue over five years, according to R&D MedTech, the maker of an EHR system. Here is the breakdown:

Practice Process Improvements ($216,300). A federal study found an EHR for a single physician yielded savings $26,600 in year one, $41,300 in year two, $31,400 in year three, $85,100 in year four and $85,100 in year five.

More Revenue Through Better Coding ($210,000). A study of 14 small practices found each physician could raise his/her revenue by as much $42,000 per year with increased coding levels resulting from implementation of EHR.

Malpractice Liability Insurance Discount ($25,000). Many malpractice insurance carriers are offering physicians discounts of 2-5 percent for using an EHR in their practice, on the premise the EHR system will reduce risk by helping to eliminate some of the most common reasons for claims, such as oversights on patient record reviews or notifying patients of prescription refills.

PQRI Financial Incentives ($50,000). The Physician Quality Reporting Initiative provides financial incentives of up to an additional 2 percent of Medicare payments to physicians who successfully report on specific quality measures provided to patients. Incentive payments range from $1,000 to over $98,000.

E-Prescribe Stimulus ($6,000). This amount covers two years of incentives, assuming most practices will switch to the full Medicare EHR stimulus incentive available in 2011.

Medicare/Medicaid Stimulus ($44,000/$63,750). Starting in 2011, physicians who meet the “meaningful use” criteria for certified EHRs for all applicable years would receive $44,000 through Medicare or $63,750 through Medicaid.

Tax Incentive ($250,000). The American Recovery and Reinvestment Act amended Section 179 of the Tax Code to increase the small business expense for qualified property to $250,000 with a 50 percent bonus depreciation.

Clinical Trial Revenue ($500,000). For clinical trials, additional new revenue is available to practices using EHR that was not available with paper records.

In-House Pharmacy Revenue ($360,000). This involves linking EHR to an on-site dispensing system in place of phoning or faxing prescriptions to the pharmacist, making call-backs for non-formulary drugs, and answering inquiries because of illegible handwriting and mandated prior authorization for refills.

See the full estimate by R&D MedTech.

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.

Extended COBRA subsidy could be extended again

The COBRA subsidy for laid off workers has been extended and expanded. On Dec. 19, 2009, President Obama signed the Department of Defense Appropriations Act for Fiscal Year 2010, which includes an extension of the government-funded COBRA premium subsidy provided in the American Recovery and Reinvestment Act of 2009 (ARRA).

The original subsidy program under ARRA provided a nine-month 65% premium subsidy for COBRA coverage to eligible individuals who were involuntarily terminated from their job and who also lost coverage as a result of the termination on or after Sept. 1, 2008 through Dec. 31, 2009.

The new legislation preserves the amount of the subsidy at 65%, but it alters the original subsidy in several ways, including: extending the period during which an eligible individual may qualify to receive the subsidy; extending the length of time eligible individuals may receive the subsidy; and providing new notice requirements.

The legislation extends the period of eligibility by replacing the original Dec. 31, 2009, cutoff date with a Feb. 28, 2010, cutoff. The subsidy is, therefore, now available to eligible individuals who are involuntarily terminated on or before Feb. 28, 2010. The new legislation also provides that the involuntary termination must occur on or before the cutoff, which differs from the previous version of the subsidy that required both the termination and the loss of coverage to occur on or before the cutoff date.

For example, an eligible individual who is terminated as of Feb. 1, 2010, and has coverage through the end of February is eligible for the subsidy under the new legislation even though the loss of coverage would occur after Feb. 28, 2010.

The new legislation also increases the maximum period to receive the subsidy from nine to fifteen months. Because that increase is also retroactive, employees involuntarily terminated between Sept. 1, 2008 and Dec. 31, 2009, who exhausted their entitlement will now have an additional six-month period. Eligible individuals whose maximum subsidized period already expired will be permitted to reinstate their coverage by paying the retroactive subsidized premiums.

Further, depending on the particular circumstances, an eligible individual may also be entitled under the new legislation to receive a refund (or credit) for any overpaid premiums that were made after exhausting the nine-month premium subsidy.

MUST GIVE NOTICE

There are also a number of new notice requirements provided in the recent legislation. For example, the recent legislation requires plan administrators to provide notice regarding these changes to individuals who were eligible for the subsidy on or after Oct. 31, 2009, or who experience a qualifying event (consisting of termination of employment) relating to COBRA coverage on or after this date. The notice must be given no later than Feb. 17, 2010; however, for individuals eligible for the subsidy on or after Dec. 19, 2009, the notice must comply with the COBRA general notification requirements.

One final point: The COBRA subsidy may be extended again. An extension to June 30, 2010, has been proposed in legislation known as the Jobs for Main Street Act, which is currently before Congress.

This column is written for informational purposes only and should not be construed as legal advice.

Barry Senterfitt is a managing shareholder at Greenberg Traurig, LLP, Austin, Texas.

Janet Farrer is an associate at Greenberg Traurig LLP, Austin, Texas.

Barry Senterfitt
Janet Farrer

5 Steps to Creating a Balanced Pain Management Surgery Center

Pain management can be a profitable addition to a surgery center. However, due to the nature of the specialty, balance is essential to the success of pain management.

Mike Heifferon, Ph.D, MBA, chief operating officer, and Marie Masztak, RN, BEd, vice president of nursing, of Deca Health, a management, billing and development company specializing in interventional pain management services, provide the following five steps to creating a balanced pain management practice in your ASC.

What is a balanced pain management practice?
Mr. Heifferon says that a balanced practice is based upon four different relevant benchmarking standards — financial, patient, provider and staff perspectives. According to Mr. Heiffron, a high performing pain management practice will be in the 90th percentile on each of these areas in benchmarking surveys.

Each area measures different competencies of the practice. “The financial perspective comes from the point of view of collections and net income,” Mr. Heiffron says. “The patient perspective looks at patient satisfaction and outcomes. The provider perspective looks at the provider satisfaction and productivity. The staff perspective looks at the staff satisfaction and productivity.”

In order to keep track of how your pain management practice is performing, Mr. Heifferon suggests using metrics to measure areas like satisfaction and productivity at least monthly, if not daily or weekly. “The more frequently you measure the results, the more frequently you will be able to take action and improve performance,” he says.

Step one: Recruit good physicians
Dedicated, talented physicians are essential to any successful service line in an ASC. Because of increased scrutiny over procedure overuse and abuse, surgery centers need to ensure that their interventional pain physicians are qualified and dedicated to proper patient care. According to Mr. Heifferon, the Accreditation Association for Ambulatory Health Care requires that all physicians performing pain management at an ASC should be certified.

Mr. Heifferon and Ms. Masztak agree that pain management physicians should be board certified and/or fellowship trained. Other areas to consider are the physician’s experience with the procedures he or she will be performing and the percent of the physician’s new patients who will receive procedures according to evidence-based medicine.

Mr. Heifferon recommends bringing in physicians who want to be partners in the center or who are existing partners that aren’t making maximum use of the center. “Both parties have the same risk [in this scenario.] When the physician is not partnered with the center, they look at things, such as cost effectiveness, time off, etc., differently,” he says.

Another issue to keep in mind when bringing pain management physicians on board is the importance of separation of office practices from that of the ASC. According to Ms. Masztak, the Medicare (CMS) Guidelines require separation of the surgery center from the office in order for the surgery center to be accredited. Therefore, the physician can see patients in the office at designated times prior to or after the completion of procedures.

Step two: Meet with and educate referring physicians
Marketing is an essential tool to a surgery center’s success, and when it comes to interventional pain management, education is an essential part of marketing. Mr. Heifferon and Ms. Masztak suggest that ASCs should devote one full-time equivalent position (ideally, two part-time staffers) to marketing efforts.

Meeting with referring physicians is an important part of this step, according to Mr. Heifferon and Ms. Masztak. Representatives from the ASC should provide physicians with information regarding customer and physician satisfaction at the center as well as educational material on pain management and how it can enhance their patient’s care.

“It is important to demonstrate to new physicians that performing pain management procedures in the ASC allows them to collect a facility fee while providing high quality and safe services to their pain patients,” Mr. Heifferon says.

Ms. Masztak says, “One aspect of care that can enhance access for patients into pain management is by promoting a good working relationship between the physicians of the ASC and the neurologists/orthopedists to gain same day access by following preset guidelines for intervention — what we call Fast Track MD.  Another would be when patients have experienced a pain management intervention previously, they are able to fast track their own care by following set guidelines for expedited care — what we call Fast Track Patient.”

Another important step, according to Ms. Masztak, is to educate the community on pain management and chronic pain treatment. “You want to create awareness and to educate physicians (and community) on what the surgery center does and show that it is about helping, rather than ’stealing,’ patients,” she says.

Step three: Consider the patient’s experience
As pain management is a high-volume specialty, addressing the patient’s experience is essential to the service line’s success. “We set a patient satisfaction goal of 98 percent at our centers,” Mr. Heifferon says. “When centers have patient satisfaction scores in the 90s, that is still good, but it is important to ask what they consider an issue (such as no-show rates) and to continually improve.”

Prior to adding pain management to your ASC, Mr. Heifferon suggests looking at three areas — patient flow, wait time and time from admission to discharge. “You need to respect the patients time as much as your own,” he says. “Because of the nature of an ambulatory surgery (need for another person to drive/pick up patient, etc.) it is important to be able to give the patient a close approximation of the amount of time they will spend at the center.”

For this reason, ASCs need to ensure they will be able to handle the patient load and the quick turnover time needed for pain procedures, which are typically about 15 minutes in length. The short procedure times often mean patients will wait longer in prep and recovery than in the actual time it takes to perform the procedure. Therefore, efficiency is critical.

Physician output may also be affected by poor patient satisfaction, according to Mr. Heifferon and Ms. Masztak. “Poor patient outcomes can often result in a physician using pain management or the surgery center less,” Mr. Heifferon says. “You may not know this until you drill down to and examine trends on a physician level.”

Step four: Understand payor issues specific to pain management
Communication is essential to ensuring the ASC and physician are reimbursed properly for pain management procedures. “You need to check whether a patient’s insurance covers the pain management procedures and make sure the billing department is aware of co-pays or what current outstanding debt may be,” says Ms. Masztak. “Also, communicate with the patient to know whether insurance is covering the procedure and with the physician to make sure medical necessity is demonstrated.”

Mr. Heifferon says it is important to communicate any costs to the patient prior to the procedure.

Mr. Heifferon and Ms. Masztak offer the following advice for ensuring proper billing and reimbursement of pain management procedures in your surgery center:

• Know your billing guidelines per insurance carrier for pain management procedure.
• Make sure the physician’s and ASC’s charges match exactly.
• The correct levels must be billed, so it is important to know the difference between disc levels and in-between levels and have this clarified on the physician’s report as necessary.
• Know modifiers that pertain to the ASC and its procedures.
• Anesthesia is billed per insurance carrier guidelines, so be aware of what is and can be used for the procedure.

Step five: Offer profitable procedures
As with any service line offered in your ASC, providing the right mix of procedures is essential to success. It is essential that all procedures be verified for insurance coverage in the ASC prior to the physician performing the procedure.

The following eight procedures are identified by Mr. Heiffron and Ms. Masztak as the most common performed in a surgery center:

• SI steroid joint injection
• Cervical epidural steroid injection
• Lumbar epidural steroid injection
• Spinal Cord Stimulator Trials are done to evaluate whether this is the best mechanism to control chronic pain
• Cervical facet injection
• Lumbar facet injection
• Transforaminal epidural steroid injections and selective nerve blocks
• Radiofrequency ablation procedures. It is important to not that prior to adding RFA to a surgical center, proper cost and volume analysis is necessary. These units are expensive and if volume is not adequate, then a per case arrangement with the unit cost built into the supplies often can be arranged.

“With the constant downward pressure on professional reimbursement, interventional pain management physicians should be looking for alternative sources of income and for reductions in practice overhead expense. Participation in an ASC offers an opportunity for both,” says Mr. Heifferon.

Learn more about Deca Health.

Connecticut Attorney General Brings First HIPAA Suit Under HITECH Act

Connecticut Attorney General Richard Blumenthal brought the first HIPAA action under the HITECH provisions of the American Recovery and Reinvestment Act in a suit against Health Net of Connecticut, according to report by AHA News Now.

The suit alleges that Health Net failed to secure private information for approximately 446,000 plan members and did not promptly notify them of the attorney general’s office of the security breach. It also alleges that the insurer failed to effectively train and supervise its workforce on the proper policies for maintaining the privacy of personal health information and for failing to encrypt private information.

The HITECH provisions authorize state attorneys general to enforce the Health Insurance Portability and Accountability Act.

Read the AHA New Now’s report on the Connecticut suit against Health Net.

CMS Delays Data Exchange Deadline

CMS has delayed a mandatory reporting deadline that would implement Medicare Secondary Payer reporting, according to a press release from the Medicare Advocacy Recovery Coalition.

HHS Releases Criteria on ‘Meaningful Use,’ Interoperability to Qualify for Billions in Funds for Electronic Health Records

HHS has issued two sets of proposed regulations that clarify standards hospitals, physicians and other providers must meet to be eligible for $14.1 billion and $27.3 billion in funding under the HITECH Act, part of the American Recovery and Reinvestment Act of 2009, according to an HHS release.

1. Definition of “meaningful use.” A proposed CMS rule defines the concept of “meaningful use” of technology that providers must demonstrate to receive funds for installing electronic health records.

The criteria would be phased in, starting with basic requirements reflecting currently available technological capabilities and then establishing stricter and more extensive criteria.

A provider would need to be using certified EHR technology in a manner that improves quality, safety and efficiency of healthcare delivery, reduces healthcare disparities, engages patients and families, improves care coordination, improves population and public health and ensures adequate privacy and security protections for personal health information.

The exact criteria that providers have to meet in the first phase of implementation are listed on Table 2 on page 103 of the 556-page proposed rule (pdf).

2. Interoperability standards. An interim final regulation from the Office of the National Coordinator for Health Information Technology sets down interoperability standards to exchange healthcare data between each provider and between providers and patients.

The regulations describe standardized formats for functions such as clinical summaries, medical descriptions of clinical conditions and test results and how that information is exchanged over the Internet.

The interim final regulation will go into effect 30 days after publication, with an opportunity for public comment and refinement over the next 60 days.

Read the HHS release on HITECH.

Region C Recovery Audit Contractor Posts New CMS-Approved Audit Issues

Connolly Healthcare, the Medicare recovery audit contractor for Region C, has updated its CMS approved audit issues for RAC review, according to Connolly Healthcare’s Web site.

Connolly Healthcare has posted at least 24 specific issues, with explanations, pertaining to DRG validation for inpatient hospitals.

The issues affect providers in Alabama, Colorado, Florida, Georgia, New Mexico, North Carolina, Oklahoma, South Carolina, Tennessee and Texas.

Read Connolly Healthcare’s Web page on CMS-approved audit issues.

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.

Alcon’s Fourth Quarter Sales Rise 14.5 Percent

Fourth Quarter Highlights

Organic sales growth was 8.5 percent (+14.5 percent reported) as sales increased to $1.72 billion
Organic sales growth in emerging markets was 11.5 percent (+19.3 percent reported)
Adjusted diluted EPS rose 14.2 percent to $1.61 (+7.1 percent to $1.51 reported)2009 Highlights

Organic sales growth was 6.3 percent (+3.3 percent reported) as sales increased to $6.50 billion
Achieved broad-based global market share gains
Second half results reflect progress toward market recovery
Adjusted diluted EPS rose 13.5 percent to $6.81 (-1.9 percent to $6.66 reported)
Board will propose to shareholders a dividend of 3.95 Swiss francs per share
HUENENBERG, Switzerl…

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