VEGF Trap-Eye yields positive DME Phase II data

VEGF Trap-Eye demonstrated a statistically significant improvement in visual acuity over 24 weeks compared to macular laser therapy in patients with diabetic macular edema (DME), said co-developers Regeneron Pharmaceuticals (Tarrytown, N.Y.) and Bayer Healthcare (Leuverkusen, Germany) in a joint press release.

In this study, visual acuity improvement was assessed by the mean number of letters gained over the initial 24 weeks of the study, the companies said. The double-masked, prospective, randomized, multi-center Phase II trial evaluated 219 patients with clinically significant DME with central macular involvement. The patients were randomized to five groups.

The control group was given macular laser therapy at week one, and these patients were eligible for repeat laser treatments, but these were available in limited frequency of no more than at 16-week intervals. A total of two groups received monthly doses of 0.5 or 2.0 mg VEGF Trap-Eye throughout the six-month dosing period, and two groups received three initial monthly doses of 2.0 mg of VEGF Trap-Eye (at baseline and weeks four and eight) followed through week 24 by either every eight-week dosing or “as needed” dosing with specific repeat dosing parameters. At week 24, the macular laser therapy group (N=44;1.7 treatments) had gained +2.5 letters; the VEGF Trap-Eye 0.5 mg monthly group (n=44; 5.6 injections) had gained +8.6 letters; the VEGF Trap-Eye 2 mg monthly group (N=44; 5.5 injections) had gained +11.4 letters; the group receiving VEGF Trap-Eye 2 mg every other month, following three monthly injections (N=42; 3.8 injections) gained +8.5 letters, and the group receiving VEGF Trap-Eye as needed following three monthly injections (N=45; 4.4 injections) gained +10.3 letters.

Regeneron said additional results will be available later this year.

Getting Skin in the Game

Orthopedic surgery can be a demanding specialty, and with its rewards comes its challenges and opportunities. No one knows this better than J.F. James Davidson, MD, who specializes in sports medicine, shoulder and knee surgery and who is part of Canyon Orthopaedic Surgeons and also practices at Gateway Surgery Center, both in the metropolitan Phoenix area. He discusses life inside and outside of the OR.

Q: Why was the specialty of orthopedics right for you?

A: I greatly respect physicians in other fields such as family practice, oncology and trauma surgery, to name just a few. Good physicians can solve a complicated medical puzzle and potentially save a sick person’s life. These physicians carry the burden of a weighty responsibility. One reason I chose orthopedics and specifically the area of sports medicine is because our patients usually have treatable problems and the capacity for relatively rapid improvement. They usually do not have life threatening conditions and are highly motivated to improve in order to maximize their quality of life. I remember rotating through cardiology and nephrology in medical school and learning the serious consequences of chronic disease. On the first day of the orthopedic clinic we examined a man with a fractured patella. The patient jovially answered our questions regarding how he managed to be kicked in the knee by a goat. In spite of the discomfort of the fracture the patient laughed at his unusual predicament. I though, now I have found the right specialty.

Q: The practice of medicine is becoming more challenging in terms of medical malpractice, tighter reimbursement, etc., so how do you cope with these modern challenges?

A: I have had some very good teachers and role models. Bill Brainard, MD, one of the founders of our group, Canyon Orthopaedics, taught by example the benefit of finding enjoyment in working with patients and colleagues, and in performing surgery. Our practice has the innate rewards of helping people, solving problems, interacting with others. My partners and I feel fortunate to do what we do. The negatives certainly can be a drain on the system, but we try to focus on the positive reasons that we come to work each day.

Q: Most physicians are never trained in business, and when they become medical entrepreneurs, they can be unprepared for the rigors of business. What has been the most valuable lesson you have learned about being a medical entrepreneur?

A: As I mentioned, I have had some very good teachers. Dave Ott, MD, was the driving force developing our successful orthopedic ASC, Gateway Surgery Center. He proved that bringing traditional competitors together for a common business goal can lead to a win for all. Prior to Gateway’s development, Canyon Orthopedics consulted with a national firm regarding the viability of creating a small ASC as an extension of our six-man group. The consultant determined that the project would be worthwhile, but with lower volume than ideal. Instead we became part of the 30-physician Gateway ASC. This has proven to be far more efficient and successful than the project we could have done on our own. Currently under construction is the Southwest Orthopedic and Spine Hospital, an orthopedic specialty hospital in Phoenix. For this project 37 orthopedists and spine specialists have partnered with Catholic Healthcare West and USPI to build what we are determined to be the highest quality orthopedic facility in the region. Finally, a number of currently independent orthopedic groups in greater Phoenix are now working on the merger of our established practices to form a single large orthopedic group. We are hopeful that this of relationship will benefit from similar synergy as Gateway Surgery Center.

Q: What clinical lessons have you learned from sports medicine that you carry over into your other practice, and vice versa?

A: A high school athlete with the goal of a college scholarship is driven to return to the playing field as quickly as possible. A few extra days off the field may mean missing a game and a chance to help his team win and shine for a college scout. The athlete wants aggressive treatment to get him back in the game as quickly as possible. In worker’s compensation cases, an injured worker may or may not have similar motivation to get back to work quickly. However, fast-tracking treatment leads to more rapid return to the job, and less time on sick leave. Similarly, the injured worker (and his employer) benefit from avoiding unnecessary operations, but meanwhile not delaying the inevitable procedure. If a surgery ultimately will be required then spending time on additional therapy is not advantageous. Making this determination requires experience and judgment. The same is true in the treatment of the athlete. On the other hand, many middle-aged athletes as well as injured workers have degenerative changes seen on an MRI. It is important to make clinical decisions as to what changes seen on scan are degenerative and incidental versus acute and painful. An over-read of an MRI can lead to a potentially avoidable surgery in both the athlete and laborer.

Q: What are the technological/clinical advancements in orthopedic surgery that get you most excited?

A: I’m excited by a number of new devices and procedures. I’m always on the look-out for methods leading to better or more reproducible results; easier or less invasive ways of doing procedures; and faster or less painful recoveries. Throughout the year the Arthroscopy Association of North America (AANA), hosts cadaver training courses to teach new techniques and improved ways of performing standard techniques. I have been an assistant instructor at the AANA shoulder courses for years and always learn from the master faculty leading the discussion and training. Two areas of special interest are the use of preoperative MRI to determine the pattern of rotator cuff tears and method of repair; and the use of an MRI to preoperatively design cutting jigs to add to the precision of total knee replacement.

Q: What do you believe is the future for outpatient orthopedic surgery in terms of keeping up with the ever changing medical and economic environment?

A: Practicing-physician involvement in management and ownership is one key. No one has a greater interest in maintaining a top-flight center than the orthopedist taking care of the patients, doing the surgery, and watching the bottom line. As we discussed earlier, my partners and I are betting on “big is better.” We built Gateway without a corporate partner. Last year for a number of reasons we sold a portion of our center to AmSurg. We are hopeful that this association will lead to economies of scale in purchasing and a stronger position in contracting. Cooperation with our colleagues has led to success in business and has improved our practice of orthopedics as well. We consult one another, adopt best practices, and learn from each other’s successes and failures. Healthcare is changing rapidly and we will all need to stay nimble to adjust to these changes.

J.F. James Davidson, MD, graduated with honors from Yale University and received his MD degree from Columbia University. He then completed his orthopedic residency and sports medicine fellowship in Phoenix. He is board certified by the American Board of Orthopaedic Surgery and is a fellow of the American Academy of Orthopaedic Surgeons. He has also served as an officer in the American Orthopedic Society for Sports Medicine and the Arthroscopy Association of North America. Davidson has published scientific papers and spoken nationally on topics ranging from anterior cruciate ligament reconstruction to arthroscopic rotator cuff repair. He is the lead spring training physician for the Chicago White Sox as well as the team orthopedist for several local schools. His special interests include disorders of the shoulder and knee. Davidson has been with Canyon Orthopaedic Surgeons since 1994.

2010 Management Guide

Dealing with Survey Deficiencies

After receiving 23 pages of citations and a threat of losing its license, a Texas ASC (that had gone three years without a state/Medicare survey) recognized its desperate situation. While many of the citations concerned the new conditions for coverage and multiple notes for the same deficiency, the center still needed to respond with corrections within 10 days. Typical of smaller facilities, the employees responsible for compliance activities are the same individuals involved in routine care. While intending to comply with regulations, patient treatment takes priority and administrative paperwork falls behind.

In addition to their daily routine, management now needed to research, evaluate and interpret the regulations in order to rewrite/update their policies within the response time. The practitioners (both administrative and physician) realized that the task they faced required the resources and skills of an outside expert. The facility searched for a consultant that could help solve their problems. Separated by 1,500 miles, with the days ticking away, recognizing travel arrangement difficulties and skyrocketing travel expenses, they requested FWI Healthcare’s assistance.

Receiving and reviewing their citations, FWI presented a cost-effective proposal to the client that was accepted. The client faxed requested documents for our analysis. We discussed existing materials and the need for changes. FWI also developed some revisions to their policy manual and the plan of correction for submission. This information was provided to the client and after telephone clarification and minor adjustments; the transcripts were ready for use.

The plan of correction was accepted and upon the surveyor’s return for a follow-up visit (finding everything to be acceptable), she recommended the license and certification be renewed.

Many small ASCs do not have personnel with experience, knowledge or time necessary to rapidly respond to deficiencies cited by survey agencies. This is where relying on the resources of consultants (who provide assistance on a fee for service basis) is invaluable. All of FWI’s work was completed with minimal expense and without either party leaving their office.

By Roger Pence, president, FWI Healthcare www.fwihealthcare.com • 419.298.3700

Challenges Unique to De Novo Facilities

De novo projects can be a long and not always painless process, but like turnarounds, they have incentives as well. With a new development, we are able to construct the center from the ground up to ensure our high standards are met and so high-quality care can be administered efficiently from day one. We are also able to form a great group of physician partners with the right balance for a successful ASC. Now, just because we get to make initial decisions on the facility and the business with our partners, it is not always roses when developing a new center. We deal with doubting partners, setbacks, stumbles and roadblocks. In the case of our new de novo facility in Mt. Dora, Fla. we hit an unusual roadblock — gopher turtles. Yes, gopher turtles. This protected species was living on our construction site. We had to have the turtles moved, but that could only be done after three consecutive days of 50 degrees or warmer weather. The turtle relocation caused about a six-week delay in the building process, and while no one could have anticipated a gopher turtle infestation, we took care of the situation and did what we could to get the project back on track.

We found that the perspective of the partnering physicians in de novo projects is quite different from that of partners in turnarounds. While in turnarounds we are often thought of as better managers than we are, sometimes in new developments we are thought of as worse. Partners focused on financial returns view any stumble on the way to distributions as a failure, when in fact, stumbles are a part of the process and sometimes result in positive outcomes. The objective is to have the “wiggle room” to adjust, correct problems, and move forward.

No matter what we encounter along the path to developing a new center, we are committed to our partners and the success of the center and look forward to developing new, successful centers across the country.

By Tom Mallon, CEO, Regent Surgical Health

www.regentsurgicalhealth.com 708.492.0531

Ostrich Strategies for ASCs: Never A Good Idea

The phrase “burying your head in the sand” has become synonymous with hiding from the truth or hiding at the first sign of danger. Ostriches are alleged to do that, but they actually do not. However, owners of distressed outpatient centers sometimes really do.

Our firm gets involved in helping distressed outpatient centers, including surgery centers, and our experience has shown that it is the rare owner who does not “bury his (or her) head in the sand” hoping that something will occur that will cause the source of the distress to simply go away. Employing an “ostrich strategy” is a bad idea, as well as a waste of valuable time and resources because the sources of distress rarely go away simply and easily.

The “ostrich strategy” usually results in the center being behind in payments to lenders, landlords, the taxing authority, staff and most vendors by the time we get involved. The task of pulling your head out of the sand and developing workable strategies is complex and multi-dimensional, and involves lawyers and lots of different personalities. In addition, there are always varying degrees of trust among the owners and the managers (who are also often owners). Getting to the core problems requires information analysis, lots of conversation and a site visit or two. Once those core issues are made clear, then the people leading the charge put a simple strategy in place. It needs to be simple because additional and incremental complexity will only complicate matters and likely make things worse. Our firm often leads the charge, but many times we do it in tandem with the center’s lawyers. Depending upon how far behind the center is with various creditors and what legal actions have already been taken, the lawyers may well take the lead.

Follow your strategies, keep your head out of the sand, stay calm and focused, engage the right professionals for you and you may be able to yourself of the sources of distress that caused you the problems in the first place.

By Robert S. Goodman, managing partner, The Mansfield Group www.mansfield-group.com 609.267.0990

Adding Specialties to Increase Profitability

Foundation Surgery Affiliate of Huntingdon Valley, Pa. is an AAAHC-accredited, multi-specialty ASC that opened in 2003. With four operating rooms, two procedure rooms and 19 surgeon partners, this 18,000-square-foot facility was profitable; however, there was still a tremendous opportunity for growth through increasing OR utilization and case volume. “We continually strive to develop new tools and methods that will enhance the profitability of our centers while also adapting to the changing outpatient surgery environment,” says FSA chief operations officer Thomas A. Newman. He recalls the FSA specialty and case analysis:

1. Take inventory. FSA creates a checklist of all specialties that can be performed at an ASC.

2. Analyze and evaluate. Management performs an extensive cost/benefit analysis, weighing equipment and labor costs against typical revenues provided by the specialty.

3. Determine which specialty is most worth pursuing.

4. Recruit surgeons. Utilize data collected in steps 1-3 and tap existing surgery partners as a primary resource for new partner candidates.

In the case of Huntingdon Valley, a surgeon partner suggested that the center consider adding fertility as a specialty. Based on that recommendation, FSA performed steps 2-4. During the first month of adding fertility, case volume increased 12 percent and overall revenues increased by more than 25 percent. As a result of this exercise, FSA formalized the process and rolled it out to all of its centers.

“Our center was already doing quite well when FSA performed the specialty and case analysis and presented the impact of adding gynecology partners specializing in fertility,” says center administrator Robert Puglisi. “Now, return is even higher as a direct result of adding our reproductive medicine partners.”

Larry Barmat, MD, one of the center’s fertility partners, says, “Reproductive medicine is almost tailored to the ASC environment because the procedures are of short duration and low risk, thereby lending them to being done in an outpatient setting.”

Chairman of the board Robert Mannherz, MD, says, “The addition of reproductive medicine has been positive for the center on several levels. It has increased the utilization of the center and our cash flow, as well as diversified our services to patients.”

By Caleb Germany, Foundation Surgery Affiliates www.foundationsurgery.com800.783.0404

Reimbursement and Billing Compliance Issues

A full financial, business office and clinical evaluation was performed by Surgery Consultants of America (SCA) and Serbin Surgery Center Billing (SCB); however, this case study is reporting only reimbursement and billing compliance issues. The initial findings were determined during the evaluation. The current improvements are results obtained after twelve months of reimbursement management by SCB.

The Medicare-certified, multi-specialty center was open 18 months, has two ORs and performs an average of 100 cases per month; the physician-owned clinic shared the same site with the ASC. The challenges were as follows:

» Practice software not meeting all ASC needs

» Billing outsourced to clinic billing staff resulting in:

•overwhelming volume

•increase in errors due to lack of ASC billing knowledge

» Revenue stream reduced to trickle

» Days in A/R escalating – 97 at time of evaluation

» Claim backlog growing – minimum 7 to 10 days lag time between services rendered and subsequent posting and billing

» Denial rate climbing – 20 percent to 25 percent first time denial rate

» Cost of staffing and supplies as a percentage of revenue continuing to increase because of claim backlog

» Non-compliance concerns mounting

Our findings and recommendations were as follows:

Processes

» Using practice software

» Recommend acquiring ASC software

» No CMS list of ASC covered services or matrix of insurance contracts

» Recommend providing both to scheduler and insurance verifier

» No up-front collections

» Recommend notifying patient of financial responsibility before DOS

Reimbursement

» Billing not up-to-date

» Recommend hiring additional staff or outsourcing

» Coding inaccuracies identified

» Recommend coding audit by certified coder – rebill where necessary

» Not following up on submitted claims

» Recommend audit to determine timely filing, refunds, resubmission claims

Compliance

» Receptionist making patient contact calls

» Recommend moving these calls to back desk for HIPAA reasons

» No notification to payor of out-of-network status

» Recommend notifying payor at time of verification and again at billing

» No advance notification of financial policy to patient

» Recommend providing written policy prior to DOS via phone or brochure

Our evaluation resulted in the following changes:

» Appointed separate ASC administrator

» Changed to ASC software

» Revised fee schedule

» Acquired copies of payor contracts

» Initiated use of bank lockbox

» Created new insurance verification position

» Established process to collect co-pays

» Developed financial policies to handle self-pay patients, payment plans, financial hardship cases, etc.

» Made changes in business office task responsibilities

Improvements included:

» No billing backlog

» Decrease in days in A/R – 58 percent (97 days to 41 days)

» Increase in average net revenue per case – 14 percent

» Increase in average charge per case – 31 percent

» Meeting billing compliance guidelines

By Caryl A. Serbin, RN, SSN, LHRM SURGERY CONSULTANTS OF AMERICAwww.surgecon.com 888-453-1144

Florida ASC Increases Revenues

Acting as a strategic business partner, NovaMeda dedicates an experienced team of experts to help our ASCs grow and prosper, while assuring the best possible experience and outcomes for both patients and physicians.

We recently increased the revenue of our Florida ASCs by employing a comprehensive managed care strategy. Over the last two years, we have renegotiated contracts with major payors in Florida and increased the value of the contracts by as much as 20 percent. This has equated to an increase in revenue of 5 percent to 10 percent for each of our four ASCs in Florida.

Developing and executing an overall managed care strategy can lead to major revenue enhancement and overall improved financial performance of our ASCs. Our strategy is founded upon the principles of maximizing the revenue of all our managed care contracts, assuring that the ASC is getting paid what it should based on the contract, and monitoring the performance of managed-care contracts to ensure the ASC is realizing projected revenue.

Executing our managed-care strategy begins by reviewing our ASC’s total book of business and managed-care contracts. Using best-of-breed financial models, we assign a value to each contract based on payor case/mix and market dynamics, and then negotiate (or renegotiate) each contract to ensure maximum revenue generated for our ASC. An ongoing process, we employ a proactive stance on managed-care contract negotiations to ensure the profitability of our ASCs.

By Lisa Streit, director of managed care, NovaMed www.novamed.com 888-NOVAMED

Implementation, Cons & More

The Practice Partners in Healthcare (PPH) team met with the physicians and began to plan for the implementation of the single-specialty center. During the planning process PPH reviewed volumes, expenses and thresholds in the CON. It was determined that additional surgeons would be necessary to make the center successful. PPH began to recruit additional surgeons to the project. To recruit physicians it was necessary to modify the operating and partnership agreements to make the arrangement fair for all physicians and not have the initial group control the project. PPH negotiated with the groups for a successful operating agreement and partnership arrangement to allow the entry of new physicians.

The ability of a third party to develop an independent plan, negotiate and execute is necessary to assure the original group and joining physicians that the best plan for the total partnership is presented. During the negotiations it was clear that the groups combining were fierce competitors and the role of PPH was to make fair and strategic decisions that would demonstrate to both groups the combined strength in the ASC setting but allowing the market forces to continue in the practice setting. Furthermore, the individuals had to work together to develop block time schedules and utilization of the center that would present the most favorable results. In doing so PPH developed a block time schedule that interfaced with both practices clinic schedule and inpatient surgical schedules. PPH developed a strategy and schedule designed for each group’s physician to follow block time by that same group. In doing so the potential conflicts of another group adding on patients and extending the operative day would only affect that group and not the competitor.

When administrators are considering modifying of implementing block time considerations on the impact of running over to other physician block time may reduce issues by this practice. The physicians could then work within their individual groups to correct reoccurring situations. Additionally, when administrators are planning for block time the utilization of historical operative or procedure times should be utilized when evaluating the duration of the individual block to allow for the anticipated daily throughput for each surgeon.

By Larry Taylor, president and CEO, Practice Partners in Healthcare, Incwww.practicepartners.org 205.824.6250

Joint Venture Feasibility

In early 2005, Alegent Health engaged Health Inventures (HI) to perform a feasibility study for joint-venturing (JV) outpatient surgery services with physicians at their Lakeside and Bergan Mercy Medical Center campuses in Omaha, Neb. HI conducted extensive physician interviews to educate physicians about the JV process and gauge interest. Based on positive feedback from the interviews and HI’s financial forecasts, it was determined that a JV was feasible.

The degree of physician interest showed enough case volume to occupy two new facilities. However, HI determined the most immediate opportunity to establish a JV was to convert an existing two OR HOPD to a free-standing ASC in a medical office building (MOB) on the Lakeside Campus. The conversion process included obtaining licensure and certification to operate as an ASC. This facility would operate for 18 months while a new facility with four ORs and one procedure room was built in the same building.

Throughout 2005, a steering committee with representatives from HI, Alegent Health, interested physician groups and legal counsel met regularly to determine the terms of the operating agreement and the governance structure of the JV. Meanwhile, valuation firm performed a third-party valuation of the existing ASC. Based on financial projections and this valuation, HI and deal counsel developed a private placement memorandum (PPM) and subscription agreement and opened the “offering” for physician investment.

The offering closed in December 2005. Two major surgeon groups and 19 individual physicians invested in the facility for a total of 31 physician users/owners. Alegent maintains 51 percent ownership in the new LLC that leases operating space from Alegent in the MOB.

The owners appointed a management board (MB) and clinical operations committee (COC) as the principal decision making authorities. The MB has equal physician/Alegent representation and the COC is physician-controlled.

In September 2007, the physician owners moved their cases from the upstairs ASC to the newly constructed facility on the ground floor of the MOB. The high subscription rate of the offering and cash flow from the existing facility provided adequate funding for the construction without any term debt financing. Only a line of credit was needed when the facility opened.

By Catherine A. Martin, contract manager, Health Inventures, LLCwww.healthinventures.com 877.304.8940

Compiled by Jessica Barreras

Gov. Paterson proposes bill to require disclosure from PBM

New York Governor David A. Paterson has proposed legislation that would increase transparency and promote competition among pharmacy benefit managers (PBMs) by requiring them to disclose additional drug information to health plans, doctors, and patients.
“PBMs perform a valuable service, but there is little oversight of their practices and little competition,” said New York State Health Commissioner Richard Daines, M.D., in the release. “The three largest PBMs—Medco, Caremark, and Express Scripts—manage pharmacy benefits for 200 million Americans, 95% of those who have prescription drug coverage.”

Under Paterson’s bill, PBMs would be required to disclose the actual use of drugs by the health plan’s participants, any conflict of interest that the PBM might have with the health plan, any increase in the net price to the health plan for a covered drug and the reason for the increase, and all contracts entered into by the PBM with a network pharmacy or pharmaceutical manufacturer. The bill would also notify patients and disclose any relevant clinical and financial information to prescribers before a PBM could switch a patient to a more expensive drug, the governor said in the press release.

Gene expression may be linked to retinoblastoma progression

The inactivation of the 16INK4A gene may play a key role in the progression of retinoblastoma, said researchers at Thomas Jefferson University’s Sbarro Institute for Cancer Research and Molecular Medicine (Philadelphia, Pa.) in a press release.

In a recent study, published in the Journal of Cellular Physiology, researchers focused on the 16INK4A due to its suspected role in retinoblastoma progression and its link to familial cancer predisposition.

In the study, Marco G. Paggi, M.D., Ph.D., and colleagues assessed blood samples taken from 29 patients and their parents. They found low to moderate 16INK4A protein expression in five of 11 (45%) retinoblastoma tumor specimens. They also found reduced p16INK4a RNA expression in blood in 16 of 29 (55%) retinoblastoma patients compared to normal controls. This reduction was associated with the depletion of the p16INK4a gene, the researchers said in the release.

The researchers also found reduced expression in at least one parent among nine of the 16 (56%) patients with reduced p16INK4a RNA expression. This suggests a heritable susceptibility to retinoblastoma, the researchers said.

EMR 101: An Overview of Key Benefits

It’s no secret the Internet is everywhere, so it is a contradiction that millions of Americans feel secure enough to do their banking online, but the U.S. healthcare system is still wary of transitioning health and medical records into an electronic format.

As I sat with Ron Pelletier, vice president of market strategy, at a SourceMedical conference in Las Vegas, he stated, healthcare in general, grossly underutilizes the internet. We discussed one of the main reasons outpatient centers have been slow to change. “On the ASC side, things may not have been broken. Reimbursements were good, now that is changing. These centers are under pressure with reimbursements shrinking and costs going up. Many are saying, ‘In order to stay competitive and keep my business afloat, I need to find better ways of doing this.’ The necessity now is driving them.” states Pelletier.

This series of articles will cover some of the key points that need to be addressed when considering the implementation of an EMR in your ASC, including key benefits of EMRs, what to look for in a provider, how to get your staff ready for this impending transition.

To begin, we should consider the many definitions of an EMR. “There have been so many people out there that have said ‘I am selling an EMR’ and all it is is scanning in your paper and saving it to a computer,” says Craig Veach, senior vice president of operations for Amkai. “Then there are others who have a forms-based system. In the PIIM study, of the original 50 that were considered, none of those were even the forms-based systems because PIIM thought they were not commercially viable. You want something that is a true work-flow manager. Our EMR handles communications within the organization using an internal email and instant message (IM) that allows people to pass info and stay HIPAA compliant. It’s customizable on how it is set up to manage an individual organization’s workflow,” Veach adds. The Parsons Institute for Information Mapping (PIIM) study Veach refers to recently reviewed the top six EMR systems available on the market today.

This brings us to some of the key benefits a facility can gain through implementing an EMR. Michael Nolte, vice president and general manager of marketing for GE Healthcare IT, is aware that there are many questions and concerns from administrators and staff, but says that the long-term benefits will by far surpass the short-term apprehension. “In particular, for a smaller business, it’s a pretty big transition. There are three key benefits. First is the quality of care that you can deliver as a provider; when an EMR is used effectively it’s a really powerful tool. Both from a medical and a legal perspective, you have ensured that you have the right documentation in place that you are making good care decisions and that you have the ability to deliver the best quality of care for your patients. Second, is when our providers get really good at using a piece of software, and are transitioning from something that is usually more paper-based, it makes them more efficient. The ability to use their time more effectively, spending more time in the operating room and less time in the office is definitely enhanced by use of the software. And third is accuracy from a billing and reimbursement standpoint. In terms of getting a clear, well documented perspective on activity so that clinicians are getting paid for what they do everyday.”

On a more fundamental level, there are cost benefits in paper saving. “A lot of these centers are drowning in paper,” affirms Sean Benson, co-founder of ProVation Medical, part of Wolters Kluwer Health. “They are documenting everything on paper and with that come a lot of cost and inefficiencies. That includes the cost of paper, storage of charts, doing a chart pull, and assembling charts. All of those costs are really taken out of the system when you move to an electronic medical record. You are taking a lot of the redundancies out of the system.”

Oftentimes, hearing the benefits from peers can be most beneficial. Daren Smith, BSN, administrator at Fremont Surgical Center in Fremont, Neb., also shares his thoughts about the benefits. “It has so much capability to increase the level of quality of care that you are able to give to your patients. The EHR system capabilities to cross-check medications and make sure that the required information is there. Also, the ability for that information to be shared widely makes it very important. We have also found that it lends some credibility to your organization; that you are ahead of the game, ahead of the curve.”

What should an ASC look for in a provider? Administrators may want to consider what type of ASC in which they are working. If the ASC is a brand-new facility, it makes sense to start with an EMR. “For new ASCs, it’s almost a no brainer in terms of EMR and full-automation. We find that it is a straight forward conversation when you ask a new ASC, ‘why would you start by duplicating the old paper-based workflow when you have a chance to start fresh?’ The question is usually positively viewed since it just makes sense to go electronic from the outset. Existing ASCs are also interested, but have a little more adaptation to existing processes that they might see necessary. Actually, it’s an opportunity to look at current workflow and adapt it a little to realize the benefits from the software,” Don Fallati, senior vice president of marketing, Amkai states.

The existing ASC wanting to convert to an EMR has various items to address. While a new staff in a new ASC can face the implementation of an EMR with ease, staff members in current less technology-based facilities may be quick to decline the idea of learning anything new. The biggest part of getting ready for an EMR system is to realize there will be change. “If the staff, especially the internal champions or the leaders of the organization are resistant to change then they are going to be real problems. If you can identify key leaders within the organization, who understand that change is an important part of the process, and the short term challenges are worth the longer term benefits moving to an electronic system then you are really on the right track.”, states Benson.

Joe Macies, CEO of Amkai adds, “These systems today are modular. You don’t have to swallow the entire package and it doesn’t have to change every single facet of workflow. My two words of advice would be: get started. The EMR benefits are so great over such a long term, and eventually so necessary, I think, in any healthcare provider organization that you can get started and have a fairly graceful migration of your people at a reasonable pace over time when you’ve got modular software that fits users needs. It’s helpful not to approach EMR as having to find the perfect solution.”

Stay tuned to the second part of this series, EMR 202: How to Get Ready for Implementation where SurgiStrategies speaks to some ASCs that are in the process of EMR implementation or have an EMR in place where they discuss concerns challenges and advice.

Tuberculosis treatment requires medication and monitoring

Tuberculosis (TB) continues to be a problem in the United States, particularly among at-risk populations. The groups at highest risk for TB include people living with someone who has active disease, and those with a lowered immune response, such as HIV patients.

“Every medical center in our region has tuberculosis on its risk assessment list, that is, its list of potential issues to monitor on a continuing basis,” says Stephen Parodi, MD, chief of infectious disease for Kaiser Permanente, Northern California. “We make it a priority to ensure that patients at risk for infection with TB are screened for latent infections.”

The region includes 20 medical centers serving 3.1 million members. Dr. Parodi says the plan encourages screening for those who have been incarcerated or have a history of IV drug use and has educated primary care physicians and pediatricians to screen for TB.

“We saw a significant surge in TB cases when the HIV epidemic first hit; since then we’ve seen a leveling off,” he says. “In terms of epidemiology, it’s interesting to note that many cases we’re now seeing are in foreign-born individuals. We live in a global world, and we need to be aware that constant vigilance and aggressive, early recognition of latent and active disease will prevent further spread.”

Most people infected with tuberculosis don’t have any symptoms. When a patient is positive for latent TB, the clinician looks at the risk factors and determines (based on criteria from the Centers for Disease Control) whether the person is a candidate for preventive medicine.

“Preventive medicine is a lot easier than treating the active form of the disease,” Dr. Parodi says. “With latent disease we can treat with one drug, as opposed to active disease, where we typically have to use a minimum of four drugs initially.”

Patients who develop active TB experience symptoms such as weight loss, fever, night sweats, cough, chest pain and bloody sputum.

“Until susceptibility results are available, empiric initial treatment for active TB should include four drugs: isoniazid, rifampin, pyrazinamide and ethambutol,” says Mark Abramowicz, MD, editor-in-chief of The Medical Letter on Drugs and Therapeutics, a non-profit newsletter that critically appraises drugs. “When susceptibility to isoniazid, rifampin and pyrazinamide has been documented, ethambutol can be omitted.”

DIRECT PATIENT OBSERVATION NEEDED

One of the greatest problems in TB treatment today is the emergence of drug-resistant strains of the bacteria.

“Poor adherence to TB therapy is the most common cause of treatment failure, and can lead to drug resistance,” says Dr. Abramowicz. “Medical Letter consultants recommend that most patients, including those with disease due to drug-susceptible strains, take drugs for active TB under direct observation.”

At Kaiser, patients with active TB are monitored closely, typically with a monthly office visit. Kaiser physicians sign the orders for directly observed therapy, which is provided by the county public health department.

“We provide medications, lab testing to monitor potential side effects, symptom assessments, and imaging, x-rays or CT scans as needed,” Dr. Parodi says. “Protocols differ from jurisdiction to jurisdiction in terms of exactly who gets directly observed therapy, but in our experience, most counties are aggressive. If there is an identified case of active, potentially contagious TB, that person is receiving directly observed therapy.”

Extensively drug-resistant TB is a form of the disease caused by strains that are resistant to all the most effective anti-TB drugs. The World Health Organization reports that 41 countries have cases of extensively drug-resistant TB, including the United States.

“Confirmed multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis should be treated with directly observed therapy in collaboration with a clinician familiar with management of these conditions,” says Dr. Abramowicz. “Regimens for these conditions must include at least four drugs to which the organism is susceptible; the duration of therapy usually should be 18 to 24 months.”

In recent years, researchers have made considerable progress toward developing new medications that could treat tuberculosis more effectively. Eleven new medications from seven different drug classes are currently in clinical trials for tuberculosis.

“The medications that are farthest along are antibiotics called fluoroquinolones, which have the potential to shorten the duration of therapy,” says Eric Nuermberger, MD, associate professor of medicine and international health at Johns Hopkins School of Medicine, who is on the faculty of Hopkins’ Center for Tuberculosis Research. “Current medications require six to nine months; we hope fluoroquinolones will reduce that to four months. Four phase II studies of fluoroquinolones are currently underway, and we should have an answer in about two years.”

Fluoroquinolone drugs are already on the market in the United States for acute conditions such as community-acquired respiratory tract infections and urinary tract infections.

Of the medications that are being developed solely for tuberculosis, the one that’s furthest along is TMC207, developed by Tibotec.

According to a recent study in The New England Journal of Medicine, when researchers added TMC207 to a standard regimen for multidrug-resistant tuberculosis, a significantly higher proportion of patients had negative sputum cultures at two months.

Elaine Zablocki has been reporting on healthcare for more than 20 years. She is based in Oregon.

This article is based on information supplied by The Medical Letter (www.medicalletter.org), a non-profit organization that publishes newsletters offering critical appraisals of new drugs and comparative reviews of older drugs. The Medical Letter is independent of the pharmaceutical industry and supported entirely by subscription sales. Institutional site license inquiries can be sent to info@medicalletter.org [info@medicalletter.org]

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.

Kaiser questions complexity of drug-safety programs

Kaiser Permanente is concerned that too many diverse drug safety programs will impose a burden on the healthcare system and on patients, and that this will drive up costs and limit access to therapies.

The integrated health plan wants a greater say in how the Food and Drug Administration (FDA) and drug companies design and implement these programs to ensure they don’t discriminate against certain healthcare providers and pharmacies.

In 2007, Congress expanded FDA’s authority to require drug makers to establish Risk Evaluation and Mitigation Strategies (REMS) to enhance the safe and appropriate use of marketed medicines. Most of the 80 or more approved REMS are fairly modest, only providing patients with printed medication guides that describe proper drug use.

But a growing number of these programs also include more extensive Elements to Assure Safe Use (ETASU), which tightly manage prescribing and dispensing of high-risk medicines. ETASU can involve limited distribution of the drug and certification of prescribers and pharmacists to ensure appropriate prescribing and dispensing; in some cases patients have to be tested to ensure they’re not pregnant, for example, or that the drug is not causing harmful reactions.

COST AND ACCESS QUESTIONED

Kaiser is concerned that its physicians and pharmacies will be cut out of such certification and distribution programs, and that its patients will have difficulty gaining access to needed therapies. Such requirements could increase costs for health plans and for consumers, limiting access to needed drugs and the overall benefits of the REMS safety program.

The problem has not been that noticeable so far because most REMS with ETASU have involved drugs for relatively small patient populations. However, FDA is considering a more involved REMS for the broad class of extended-use opioids, and might weigh such an approach for erythropoietin-stimulating agents (for red blood cell production), drugs that are expensive and widely used.

Consequently, Kaiser has formally petitioned FDA to open up its process for designing and approving REMS with ETASU. Kaiser proposes that FDA’s public advisory committees review such processes to make the proposals more transparent and to allow plans and providers to have a say. That would give Kaiser an opportunity to have its own specialty pharmacy operation included in a REMS network.

The health plan also wants to ensure that REMS programs protect the privacy of patient health information.

Clinical consequences drive the need for pharmacy integration

THE INTEGRATION OF pharmacy and medical data has gone a step further into the coordination of services. A whitepaper published in March 2009 by several pharmacy organizations attributes a new focus on collaboration to an uptick in clinical consequences and costs of medication misuse and non-adherence; a shift from acute to chronic care; the increasing role of pharmacists; and the growing number and complexity of medications.

“Coordinating pharmacy and medical benefits paints a total picture of compliance without a gap in data, and thus, impacts outcomes,” says Nita Stella, senior vice president, ActiveHealth Management, a care management company headquartered in New York City. “In addition, sharing information can increase medication safety and effectiveness by triggering alerts to flag drug-to-drug interactions, contraindicated drugs and non-compliance.”

Integration is an effective vehicle for identifying high-risk members and putting value-based benefit design into place. For example, an integrated system could identify high-risk members and lower copayments for those individuals or for an entire class of drugs, such as stains, to encourage compliance.

David Dross, leader of the managed pharmacy practice for Mercer Inc. in Houston, says that integration is easier if one vendor is managing both sides of the equation. While he believes that a carve-out pharmacy is willing to share its data, he says the medical vendor could be the “fly in the ointment” because there may be a fee attached to the provision of data.

The Clinical Pharmacy Cardiac Risk Service (CPCRS) at Kaiser Permanente Colorado combines KP HealthConnect, an electronic health record (EHR), with an electronic care registry, proactive patient outreach, wellness and medication management.

After high-risk patients for coronary artery disease are identified, they are referred to CPCRS. The program has served 21.000 patients since 1998.

“We are able to determine who has a cardiovascular event and deliver continuity of care cost-efficiently by integrating pharmacy and nursing teams with patients and their doctors and using technology and other tools to address problems,” says Jon Rasmussen, chief of clinical pharmacy, cardiovascular services. “Primary care physicians and cardiologists spend an inordinate amount of time with chronic care patients, so we’re looking for ways that pharmacists and nurses can relieve some of the burden. If these cardiac patients are managed consistently through collaboration, that frees up physicians to address acute issues.”

Results show the number of those meeting their LDL cholesterol goals increased from 26% to 73%, and screening for cholesterol rose from 55% to 97% during an average length of participation in the program of 2.3 years.

In addition, participants in the CPCRS program had an 88% reduced risk of dying from a cardiac-related cause when enrolled in the program within 90 days of a heart attack.

When members are close to release from the program, Kaiser Permanente rehabilitation nurses set up phone calls to discuss diet, exercise, depression, smoking cessation and medications. In a seamless process, Rasmussen says, after discharge, participants work closely with clinical pharmacists for long-term medication management.

Although the program has been successful by saving lives, reducing hospitalizations and recouping investment, it hasn’t been without its challenges. Among them have been getting clinicians to communicate via the EHR, developing multifunctional teams and making sure that “we target the right person with the right treatment at the right time,” he says.

THE FOUNDATION OF INTEGRATION

CIGNA is another insurer that relies on pharmacy to reduce medical costs through evidence-based medicine.

“Data sharing between the pharmacy benefit manager and the insurer is the foundation of integration,” says Claire Marie Burchill, vice president of strategy, product and marketing for CIGNA Pharmacy Management based in Bloomfield, Conn.

Many of CIGNA’s pharmacy programs demonstrate integration with the medical side with an emphasis on adherence. Although they are pharmacy-related, they have a large impact on medical cost reductions, such as emergency room visits and hospitalizations.

CIGNA’s Outcome Improvement Programs, which combine the use of prescriptions drugs, disease management and behavioral coaching, saw results in 2008:

• a 74% medication adherence rate led to 50% of those in the cholesterol program reaching their goals;
• a 78% decrease in LDL and the avoidance of 262 heart attacks annually saved $6.6 million;
• a 34% increase in use of drugs for treating asthma led to fewer emergency room visits and hospitalizations, cutting costs for participants by 50%;
• an adherence rate of 84% for diabetes drugs resulted in 13% fewer emergency room visits and 18% fewer hospitalizations; and
• a 35% increase in completion of depression treatment plans realized an 18% reduction in medical and behavioral healthcare costs.

Dovetailing with the program is CIGNA’s new CoachRx, an interactive Web site to enhance medication adherence with home delivery. A self-assessment helps members identify barriers to adherence and allows them to request daily reminders for self-care.

Those who need additional assistance can call toll-free for medication coaching sessions with a clinical pharmacist, who works with case managers. The coaching team will help find the most appropriate and cost-effective medications for a member, discuss possible side effects and reinforce the importance of taking prescribed medications as directed.

“In this way, we have used one intermediary to maximize health,” Burchill says.

To address high-cost drugs with the potential for side effects and infections, CIGNA offers TheraCare, a medication therapy management program targeting individuals using specialty injectable medications for 16 chronic conditions, such as multiple sclerosis.

“We still have a way to go in integrating pharmacy and medical benefits because the Rx benefit is administered in silos,” says Steve Mullenix, senior vice president of communications and industry relations for the National Council for Prescription Drug Programs (NCPDP). “Medicare Part D’s Medication Therapy Management Program is a step in the right direction, but we are still trying to buy drugs as inexpensively as possible without knowing the impact of the full picture. The right hand doesn’t know what the left hand is doing.”

For example, if a pharmacist dispenses a drug but it’s not refilled, that requires communication so that some action can be taken to encourage compliance.

Mullenix, whose organization focuses on developing consistent standards is concerned that without standardization, it will be difficult to create interoperability between proprietary systems.

“We are a proponent of a team approach to healthcare, including patients and pharmacists, who have become medication experts and need to be reimbursed for their guidance,” he says.

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