Urology Practice Management

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www.UroPracticeManagement.com AUA MEETING HIGHLIGHTS

Strategies for Payer–Provider Contract Negotiation: Preparation and Data Are Crucial

By Charles Bankhead

Testosterone Replacement Does Not Increase Risk for Prostate Cancer, Cardiovascular Disease

By Wayne Kuznar

Stacy Loeb, MD

T

estosterone replacement therapy does not increase the risk for aggressive prostate cancer or for cardiovascular (CV) disease. In fact, testosterone replacement in men with hypogonadism decreases these risks, according to data presented at the 2016 American Urological Association (AUA) meeting.

A study of a nationwide Swedish database revealed a 50% reduction in risk for Continued on page 4

Efficiency in the Urology Practice, Part 2: When the Patient Arrives at Your Office

By Neil H. Baum, MD Dr Baum is Professor of Clinical Urology, Tulane Medical School, and Principal, Neil Baum Urology, New Orleans, LA

S

uccessful contract negotiation comprises a process involving a realistic self-assessment, an evaluation of Continued on page 5

I

n the previous article (April 2016), I discussed how to improve efficiency in your practice before a patient arrives at your office. In this article, I discuss how to enhance efficiency when the patient arrives at your office.

The patient has arrived, provided his or her demographic information and the health questionnaire, and has been taken to the examination room. The doctor Continued on page 7

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FEATURES AUA MEETING HIGHLIGHTS Strategies for Payer–Provider Contract Negotiation: Preparation and Data Are Crucial....................................................................1

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By Charles Bankhead

Testosterone Replacement Does Not Increase Risk for Prostate Cancer, Cardiovascular Disease.......................................................1

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PRACTICE EFFICIENCIES Efficiency in the Urology Practice, Part 2: When the Patient Arrives at Your Office...........................................................................................1

By Neil H. Baum, MD

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HIPAA COMPLIANCE Implementing a Robust HIPAA Compliance Program in a Medical Practice................................................................................................10

By Angela E. Simmons

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TABLE OF CONTENTS (Continued) BLADDER CANCER Adjuvant Chemoradiotherapy May Provide Benefit in Locally Advanced Bladder Cancer................................................................12

By Phoebe Starr

DEPARTMENTS FDA NEWS FDA Approves Fluciclovine F18 Diagnostic Imaging Agent to Detect Recurrent Prostate Cancer.................................................................14 Tecentriq Receives FDA Approval for Metastatic Urothelial Bladder Cancer..................................................................................................14 WEALTH MANAGEMENT Choosing a Business Entity for Your Medical Practice..................................15

By Gary S. Sastow, Esq, and Lawrence B. Keller, CFP, CLU, ChFC, RHU, LUTCF

EDITORIAL ADVISORY BOARD Neil H. Baum, MD Professor of Clinical Urology Tulane Medical School Practicing Urologist Neil Baum Urology New Orleans, LA Cheris Craig, MBA, CMPE Chief Administrative Officer Urology of Greater Atlanta, LLC Atlanta, GA Michael deWitt Clayton, MD, FACS Urology Associates of San Luis Obispo, CA

Rick Janss, MBA, CMPE Practice Administrator Clinical Urology Associates Gadsden, AL

Jonathan Rubenstein, MD Director of Coding and Compliance Chesapeake Urology Baltimore, MD

John McMann, MS Administrator Advanced Urology Specialists, LLC Oxford, FL

James A. Sylora, MD Urologist AUS–Midwest Urology Evergreen Park, IL

Jonathan Oppenheimer, MD, FCAP Medical Director, Chief Pathologist Oppenheimer Urologic Reference Laboratory Nashville, TN

Sean M. Weiss, CCP-P, CCA-P, ACS-EM, CPC, CPC-P Vice President & Chief Compliance Officer DecisionHealth Professional Services Gaithersburg, MD

AUA Meeting Highlights

Testosterone Replacement Does Not Increase Risk for Prostate Cancer... Continued from page 1 aggressive prostate cancer among men who received TRT for >1 year compared with the control group, said Stacy Loeb, MD, Assistant Professor of Urology, New York University Langone Medical Center, who presented the study.

The study examined the association between testosterone replacement and prostate cancer using the National Prostate Cancer Register and the Prescribed Drug Register, which identified 38,570 men with a prostate cancer between 2009 and 2012, and 192,838 men without prostate cancer in the control group.

In each group, 1% of patients were using testosterone replacement. Of the patients, 59% had favorable disease, 38% had aggressive disease, and 3% had missing data on disease severity.

Testosterone replacement was not associated with overall prostate cancer risk, with an adjusted hazard ratio of 1.03.

“The type of testosterone didn’t matter. We looked at whether they used gel, injections, or other types, and there was no difference in prostate cancer risk based on the mode of administration,” said Dr Loeb.

Testosterone replacement increased the risk for favorable prostate cancer by 61% during the first year; however, this may be a detection bias, because Swedish guidelines recommend enhanced screening for prostate cancer in the first year of testosterone replacement. Overall, there was a 50% reduction in the diagnosis of aggressive prostate cancer among TRT users, with no difference in the risk for aggressive prostate cancer during the first year of TRT use.

Among the men receiving testos-

“Men who took testosterone in the longterm had fewer aggressive cancers, which suggests that replacing it to normal levels mitigates this risk.”

Although the data support the safety of long-term use of TRT, “potential protective effects of TRT remain to be proven.”

—Christopher Wallis, MD, MSc

—Stacy Loeb, MD

terone replacement for ≥1 years, the risk was reduced to 31%; after 1 year, a 56% reduction in aggressive prostate cancer was found among testosterone users versus the matched controlled.

Dr Loeb said that previous studies suggest an increased risk for aggressive prostate cancer in men with hypogonadism, and that cancer in a low-testosterone environment tends to be more aggressive.

“Our findings [show] that men who took testosterone in the long-term had fewer aggressive cancers, which suggests that replacing it to normal levels mitigates this risk,” she said.

Testosterone Replacement Reduces Risk for Prostate Cancer and CV Disease Other studies presented at the meeting confirmed the lack of relationship between testosterone use

and the incidence of aggressive prostate cancer. One study showed that men with untreated hypogonadism had an increased risk for a more severe prostate cancer phenotype than men who received testosterone.

Another study showed that testosterone decreased the risk for prostate cancer and for CV events and overall mortality. Christopher Wallis, MD, MSc, Division of Urology, University of Toronto, Ontario, Canada, and colleagues, examined 10,311 patients who had testosterone prescriptions between 2007 and 2012, and 28,029 patients in the control group without such prescriptions.

Testosterone users had a significant 12% reduction in overall mortality, with a 33% reduction among patients with exposure to testosterone in the highest tertile versus the control group. No change was seen in CV among testosterone users compared with the controls, but pa-

AUA Meeting Highlights

Strategies for Payer–Provider Contract Negotiation: Preparation and Data... Continued from page 1 your counterpart, and the development of a negotiating strategy, according to John M. Murphy, MD, MBA, Chief Executive Officer and Chief Medical Officer, Delaware Valley Urology, Mount Laurel, NJ. The process should begin years in advance of current negotiations. At the very least, the “nitty gritty—the assessment—absolutely has to start months before,” said Dr Murphy at the 2016 American Urological Association Practice Management Conference.

“If you haven’t done that yet, and you have the opportunity for your contract to evergreen, you probably should let that happen, because you’re setting yourself up to get your clock cleaned,” Dr Murphy added.

Contemporary contract negotiations have to overcome the healthcare industry’s history of “siloed” components—multiple, somewhat misaligned stakeholders pulling in different directions. Until recently, the system had enough “play” to accommodate stakeholders’ disparate interests and objectives, and to allow each to arrive at the appropriate place. This is no longer the case.

“One of the problems we face right now is that we are trimming the fat.

We are very close to having trimmed much of the fat, and we may even be getting into muscle. The practical implication of that is that unless we start pulling in the same direction... we run the significant risk that none tients with the highest exposure to testosterone had a 16% reduction in the risk for CV events.

The number of prostate cancer diagnoses was reduced by 14% in the testosterone users cohort and by 40%

of us—including the patient—will get to a position that is acceptable,” said Dr Murphy.

Transition Toward Integrated Healthcare Continued success in relationships with payers requires the recognition and appreciation that “we are in the midst of a very significant transformational change in the healthcare sys-

“Figure out what you absolutely need. What is the impressive-looking metric or measure that you couldn’t care less about? What contract terms and termination and periods do you want and why?”

—John M. Murphy, MD, MBA

tem,” Dr Murphy noted. For example, fee-for-service delivery is transitioning out in favor of value-based payment; this transition requires moving away from autonomy and toward greater integration of thought processes and actions, he said.

The transition toward integration is evidenced in the recent consolidation of payers. In the past 18 months, in those with the highest exposure.

Although the data support the safety of long-term use of TRT, “potential protective effects of testosterone replacement therapy remain to be proven,” said Dr Wallis. n

Aetna purchased Humana, Anthem acquired Cigna, and Centene purchased Health Net. Adding UnitedHealthcare––the largest payer––to the mix results in 4 payers accounting for $368 billion of the nation’s healthcare. The consolidation means that fewer payers have greater influence, approaching the $500-billion Medicare benchmark.

The trend toward consolidation has occurred within the context of steadily increased spending on healthcare for the past 50 years.

Since 1960, the proportion of the gross domestic product (GDP) attributable to healthcare has increased from 4% to more than 20%. By comparison, military spending has decreased by 50% for the same period.

“Economically, this is just not sustainable. If this trend continues, we will be spending an enormous percentage of our GDP on healthcare, and it is simply not something that can continue. That is the fundamental change behind the transformational change that is happening in 2016, relative to what you heard about...in 1990 that never really fully came to pass,” said Dr Murphy.

Payers have responded aggressively, taking several steps to control costs, including: • Forming narrow and tiered networks with differential copayments and deductibles • Reducing provider fees • Expanding value-based contracting • Using capitation to transfer risk to providers • Using discriminatory exchange networks • Forming accountable care organizations (ACOs).

Office-based physicians have been

Continued next page

AUA Meeting Highlights

Strategies for Payer–Provider Contract Negotiation: Preparation and Data... Continued from page 5 disproportionately affected by payer cutbacks compared with hospitals.

For the most frequently billed costs, hospital-based practices receive higher reimbursement than do ambulatory-based practices.

“That’s quite remarkable when you consider a couple of things. I suspect that those of you who are ambulatory-based, that you can make the claim that your quality is just as good as your hospital-based brethren.

I think you could probably use data to suggest that. There is incontrovertible evidence that you can do it less expensively outside the hospital, because you don’t have to factor in facilities use and things like that that you need to cover,” said Dr Murphy.

Clear Strategy Is Key to Successful Contract Negotiations By means of careful and thorough preparation, providers can effectively counter payers’ actions during negotiations to avoid the creation of winners and losers, and instead, arrive at agreements that do not require “giving in.”

Preparation begins with a realistic self-assessment. Dr Murphy advised providers to perform a realistic assessment of their market position, understand their competition, understand their payer mix, understand payers’ fee schedules, and determine how they bring value to the healthcare market.

Similarly, providers must have a thorough understanding of payers when entering a negotiation. Preparation calls for a careful SWOT analysis of the payers—strengths, weaknesses, opportunities, and threats.

“This can be something as simple as Google. Sometimes it’s reaching

out to your network. I get tremendously valuable information about payers when I look to provide insurance for my own company by going to brokers,” said Dr Murphy.

“Understand what the value is that you uniquely, exclusively, or better than anyone else bring to the market, and consequently to the negotiating table.”

—John M. Murphy, MD, MBA

The analysis of payers should include information about each major payer’s market share, competing payers and their market shares, and current performance profiles of the negotiating counterpart and other market players. The analysis should seek to identify whether the provider has leverage that can be brought to bear in negotiations, and whether the counterpart has weaknesses that can be exploited to provide advantage.

A provider should never enter a negotiation without a clear strategy, said Dr Murphy. As part of that strategy, the provider should know the best alternative to a negotiated agreement, the reservation—walk away—price, the desired contract terms and termination, and the points that can be conceded.

“Inflate your opening position. Obviously, you’re not going to get everything you want. Figure out what you absolutely need. What is the impressive-looking metric or measure that you couldn’t care less about? What

contract terms and termination and periods do you want and why? All of that is important, as is the language of the contract—critical to understand it,” noted Dr Murphy.

Be aware of and prepared for payers’ various negotiating strategies, including delay, lack of empowerment (not authorized to make a change or a deal), last-minute changes, “creative mathematics” (carefully crafted numbers that are carefully crafted for a reason), obfuscation, ACOs, budget restrictions (real or fiction), narrow networks, indifference, and language (read and understand all).

Providers have multiple strategies at their disposal to counter those of the payers, including recognizing and leveraging a unique, quantifiable value proposition; considering an outof-network position as an option; using public opinion as an ally; pitting payers against one another; selling the practice to a health system; and making the status quo unacceptable.

Data and Knowledge Are Power “Data and knowledge are power.

Do whatever you can to get them.

Understand what the value is that you uniquely, exclusively, or better than anyone else bring to the market, and consequently to the negotiating table. Exploit that for all it’s worth,” recommended Dr Murphy.

As a final piece of advice, Dr Murphy reminded providers of the words of Helmuth von Moltke the Elder, Chief of Staff of the Prussian army before World War I, who said, “No battle plan survives the first contact with the enemy.”

“That’s almost certainly going to happen with your insurance negotiation,” said Dr Murphy. n

Practice Efficiencies

Efficiency in the Urology Practice, Part 2: When the Patient Arrives... Continued from page 1 should meet the patient, and have a 1- to 2-minute discussion about some areas outside of the medical or urologic concerns, asking questions such as, “What kind of work do you do?”, “Where do you live?”, and “Who referred you to our practice?”

These questions endear the patient to the doctor, without discussing the specifics of the urologic problem.

Enhancing Efficiency by Using a Scribe One of the most effective methods to enhance the efficiency of my practice has been to use a scribe. A scribe is a person who shadows a physician and takes notes in the chart or on the computer on the patient’s history of present illness (HOPI), review of systems, and medical history; this allows the doctor to have more face-to-face time with the patient.

How Does a Scribe Work?

After the doctor has introduced himself or herself to a new patient, the scribe interacts with the patient, taking the patient’s HOPI, recording the patient’s medical history, and conducting the patient’s review of systems. The scribe then presents the HOPI to the doctor, and accompanies the doctor into the examination room.

At this point, the doctor may ask a few additional questions, or probe any aspects of the HOPI that require clarification or more in-depth questioning. The doctor then conducts a physical examination, and the scribe records any positive findings in the chart or in the electronic medical record (EMR).

At this juncture, the doctor can

discuss the diagnosis and the plan of management with the patient, while the scribe records the doctor’s plan of action. The doctor can then answer any questions the patient may have, and the scribe can hand over the chart or computer to the nurse.

Since I started using a scribe, I am able to see 5 to 6 additional patients each full day in the office. Before getting a scribe, you first have to decide if you need a scribe.

The nurse will make the necessary arrangements for any laboratory testing, studies, or surgeries; provide the patient with sample medications and written instructions for use of the medications; provide pertinent educational materials; and make the follow-up appointments.

While the nurse is taking care of one patient, the scribe moves to the next patient, always staying one patient ahead of the doctor.

Advantages and Disadvantages of Using a Scribe There are multiple advantages to using a scribe. Since I started using a scribe, I am able to see 5 to 6 additional patients each full day in the office. Having a scribe also allows you more time to communicate with the patient face-to-face instead of writing or using the computer.

In addition, my coding has moved from level 2-3 to level 4-5, because my scribe is more thorough than I am in conducting the review of systems and medical history, and in recording the fine nuances of the physical examination that I had often neglected to document, such as a neurologic and dermatologic examination.

The disadvantages of having a scribe include cost, time required to train the scribe, and adapting to having someone other than yourself document patients’ medical details. In the beginning, this can be frustrating, but when you notice an improvement in your efficiency, you will enjoy the luxury of having a scribe.

As a matter of fact, when my scribe is absent or on vacation and I have to use the computer, I realize how valuable she is, and how effective the technique is to enhance my practice.

Getting Started Before getting a scribe, you first have to decide if you need a scribe.

The following scenarios will help you decide whether your practice may benefit from having a scribe.

If patients need to wait more than 4 to 6 weeks to make an appointment for a routine visit, then you have a backlog of patients, and a scribe will help you reduce this backlog.

Continued next page

Practice Efficiencies

Efficiency in the Urology Practice, Part 2: When the Patient Arrives... Continued from page 7 If your last patient is scheduled at 4:00 pm or 4:30 pm, and you are not finished with patients until 5:30 pm or 6:00 pm, then a scribe can help to improve the efficiency of your practice.

If the majority of your codes are level 3 or lower, then you can improve your productivity by having a scribe.

Finally, if you are considering transitioning to an EMR system but are technophobic, then a scribe may be a natural segue to implementing the EMR.

Using Educational Videos for Patients Historically, the formula for practice productivity was low patient volumes, substantial reimbursements in a fee-for-service arrangement, and good doctor–patient relationships.

With the recent enactment of the Affordable Care Act, however, the situation has reversed––large patient volumes, decreased reimbursements for the same services that were performed a few years back, and less time spent with each patient are now the status quo.

Now more than ever before, urologists need to improve their efficiency to remain more productive. It was only a few years ago that doctors saw low volumes of patients, and were able to spend time educating patients about their medical condition and helping them understand the importance of adhering to treatment.

Today, urologists are seeing larger volumes of patients while spending less time with each patient; they do not have the luxury of providing patients with lengthy explanations about their health and having oneon-one educational discussions.

Figure 1 Script Format

1.

2.

3.

4.

5.

6.

Definition of the procedure or test How the procedure or test is performed Patient preparation for the test or procedure Expectations after the procedure or test Complications and their relative frequency Alternatives of treatment

Figure 2 iPhone in the Tripod

As a result, patients are relying more on the Internet and on other sources, such as social media, and less on their doctors to obtain medical information. Consequently, patients are often less adherent to their treatment plans, which may result in less-than-desirable health outcomes.

Creating educational videos for

your patients can help educate patients with exactly the same message you would want them to receive if you were speaking to them in your office.

This is a far more effective and appreciated method than the videos distributed by pharmaceutical companies and by vendors of equipment that you use in your office and in the hospital.

How to Create Educational Videos When creating educational videos for patients, we suggest that you select topics you discuss with your patients on a regular basis. For example, if you have a discussion with patients about prostate-specific antigen elevation multiple times daily or weekly, then this would be an appropriate topic for a video. I like to select topics that are of current interest to patients.

Next, you will need to create a script. In most instances, the script can follow the format shown in

Practice Efficiencies

Figure 1. By putting the bullet points in a PowerPoint presentation, you can create a script that serves as a teleprompter.

The quality of a video created with the iPhone or an Android device from Samsung is excellent. The only other piece of equipment that we recommend is a flexible tripod to hold the iPhone (Figure 2).

These are available on Amazon at www.amazon.com/dp/B017NA7V1 U?psc=1.

With the iPhone in the tripod attached to the computer, and the PowerPoint presentation serving as your notes, you are ready to create a video. I suggest limiting videos to 5 to 7 minutes, because this is the attention span of most patients.

The videos can be uploaded to your EMR or to separate computers in each of your examination rooms.

Each video may end with the statement, “I hope you have found this video on <name of topic> helpful, and if you open the door at the end of the video, I will return to the examination room and provide you with a summary of <name of topic>, and will answer any questions you may have.”

We refer to this as the “sandwich” technique, in which the doctor interacts with the patient first, performs the examination, shows the video, and ends with returning to the room to answer any questions the patient may have about the topic. A written summary of the topic should accompany each video.

Advantages of Educational Videos Educational videos can help to improve your office’s efficiency. For example, while patients are watching the video, you can see additional patients or perform brief office procedures; overall, you can anticipate a 15% to 20% improvement in office efficiency by using educational videos. In addition, patients will

Figure 3 Vasectomy-Related Questionnaire True or false? The ejaculate (the fluid that occurs at the time of orgasm) may contain sperm for 2 months or longer after a vasectomy True or false? Complications from a vasectomy include pain, infection, and bleeding after the procedure True or false? A semen analysis is necessary after having 15 ejaculations after the vasectomy to be certain that no sperm are in the ejaculate and that the vasectomy is successful True or false? Pregnancy can occur months or even years after a successful vasectomy

likely appreciate the education and the written summary accompanying the video.

Medical–Legal Protection Documentation is necessary to protect ourselves from litigation. It is possible to demonstrate that the patient received all the necessary information and education provided in

Creating educational videos for your patients can help educate patients with exactly the same message you would want them to receive if you were speaking to them in your office.

the video by documenting in the chart that the patient watched the video on a specific condition, procedure, or surgery.

We also suggest that you document in the chart that all the questions were answered before the patient left the office.

To confirm that the patient un-

derstood the condition, surgery, or procedure, you can use a true/false questionnaire that the patient can answer after watching the video, and include this in the chart.

An example of a questionnaire that I use after a patient watches a video on vasectomy is shown in Figure 3.

This questionnaire and the results can be added to your medical records with the following statement: “<name of patient> watched a video on the treatment of <name of condition>. The video discussed the procedure, risks, and complications; and alternatives of treatment, including <alternatives of treatment>. The patient agrees to proceeding with <name of procedure>, and understands the risks and complications associated with <name of procedure>.” We believe this makes the video an excellent medical–legal protection for the doctor, and that the video enhances the informed consent process.

Bottom Line We are challenged to be more efficient with every patient encounter.

You can enhance the efficiency of your practice by using a scribe and educational videos.

In the final article of this series, I will discuss how to manage the patient after the patient has left your practice. n

HIPAA Compliance

Implementing a Robust HIPAA Compliance Program in a Medical Practice

By Angela E. Simmons Consultant, Total Medical Compliance, Charlotte, NC

A

s we move into another year, it is important now more than ever for medical practices to ensure that they have a robust Health Insurance Portability and Accountability Act (HIPAA) compliance program in place. In 2009, the Office for Civil Rights (OCR) was appointed as the enforcement arm for HIPAA, and with that appointment came a mandate

by Congress to begin auditing entities that fall under the HIPAA rules.

In 2012, the OCR implemented its pilot audit program. During the pilot audit phase, 115 covered entities were audited for compliance with various provisions of the Privacy, Security, and Breach Notification Rules.

Since then, the OCR has developed its full audit program, and in September 2015, Jocelyn Samuels, Director of the OCR, announced that she fully expected the OCR’s audit program to kick off sometime by the first quarter of 2016.

What Makes a Good HIPAA Compliance Program?

The question now becomes, what should every medical office be doing to ensure that it can demonstrate compliance with the HIPAA rules?

The cornerstone of any HIPAA compliance program is its policies and procedures. Ensuring that every employee understands the HIPAA policies and procedures is a huge part of your HIPAA compliance program, but there is more to a compliance program than only a manual.

So, what constitutes a good HIPAA compliance program?

A well put together HIPAA com-

are communicated, and are enforced when needed. This person is also responsible for investigating, documenting, and reporting HIPAA security breaches to the US Department of Health & Human Services and to the patient when required by law. The privacy officer’s name and contact information are made available on the organization’s Notice of Privacy Practices, which should be posted in the waiting area and on the organization’s website (if one exists).

The cornerstone of any HIPAA compliance program is its policies and procedures.

pliance program has the following components: 1. A privacy and security official (which may be the same person) 2. Professional information technology (IT) support 3. Documented, communicated, and enforceable policies and procedures 4. Documentation of compliance with the HIPAA rules (forms and contracts) 5. Training 6. Sanctions 7. Safeguards.

Privacy and Security Official Each organization is required by HIPAA to appoint someone as its privacy officer. This person is responsible for ensuring that HIPAArelated policies and procedures are in place, are updated appropriately,

Professional IT Support In today’s very connected world, it is of utmost importance that every medical practice work with a professional IT group to ensure the security of its network, computers, tablets, devices, and, most important, its patients’ information. Without professional IT support, there is no way for any organization to truly know if there have been any malicious attempts to gain access to the network or to patients’ information. At the very least, all practices should have IT-managed antivirus programs and firewalls in place for protection.

Documented, Communicated, and Enforceable Policies and Procedures There are no policies unless they are documented, communicated to the employees, and enforceable by rule. Working with a third party to develop sound policies is a very good idea when it comes to HIPAA compliance. Any policy manual must encompass the HIPAA rules and the culture of the organization. It is important to remember that what the

HIPAA Compliance

policy indicates an organization does by rule is what the US Department of Health & Human Services and the OCR (which enforces the rules) will expect an organization to demonstrate. How does your office demonstrate that there are policies and procedures in place, that they are communicated to employees, and that they are enforceable? In addition, medical practices should be able to demonstrate that they update their policies and procedures at least on an annual basis.

Documenting Compliance with HIPAA Rules Every practice must have certain forms and contracts in place to de­ monstrate compliance with HIPAA rules, including: 1. Notice of privacy practices

KEY POINTS

 A good HIPAA

compliance program contains your policies and procedures, documentation, training, sanctions, and safeguards  Your compliance program must be documented, communicated, and enforceable  Training should occur when first adopting HIPAA policies, for new employees, on an annual basis for existing employees, and after a HIPAA violation  Compliance begins with the administrative or management staff, and then permeates throughout the entire practice  Do not write a rule that you are not willing to enforce

2. Acknowledgment of receipt of the privacy practices 3. Authorization (HIPAA-compliant) 4. Business associate agreements or contracts 5. Risk analysis 6. Taking inventory of the location of the electronic protected health information 7. Contingency planning 8. Corrective actions plans as needed.

Again, it is a very good idea to work with a third party in the development of these forms to ensure their adherence and compliance with HIPAA rules.

Training Under the Privacy Rule, all members of the workforce must be educated on the HIPAA rules, including administrative staff and doctors or other providers within the organization. Training should occur when an entity first adopts HIPAA policies, for any new employees, for existing employees on an annual basis, and as required for certain roles that may necessitate more in-depth knowledge of the policies.

In addition, training should occur after any incident involving a violation of HIPAA rules. It is important for medical practices to ensure that they can demonstrate a teachable moment when things go wrong, as they sometimes will. Training should always include information on HIPAA rules, the policies and procedures for the practice, and the sanctions for nonadherence to the rules. Medical practices should also release periodic reminders on topics such as e-mail safety and policy, computer use policies, and other security issues as they arise throughout the year. Remember that every aspect of HIPAA compliance must be documented, including training.

Sanctions Without a doubt, the least appealing aspect of any rule is enforcement;

however, it goes without saying that you truly do not have rules if they are not enforceable. Moreover, the HIPAA rules require medical entities to have sanctions policies that they can demonstrate are enforceable. Sanctions must apply equally to

How does your office demonstrate that there are policies and procedures in place, that they are communicated to employees, and that they are enforceable? all members of the workforce. A good sanctions policy will include levels of sanctions as they relate to specific actions. Organizations may elect to start with verbal warnings and then move to more rigid penalties for violations of HIPAA rules.

The sanctions must reflect the organization’s philosophy, and they must be written so that they can be enforced without hesitation. Do not write a rule that you are not willing to enforce.

Safeguards Every organization that falls under HIPAA rules is required to put appropriate safeguards in place that must be designed to protect the confidentiality, integrity, and availability of patient information. In other words, information that must be kept confidential is not viewed or used by any person who is not authorized to have such access.

Next, the integrity of information ensures that the data are not changed by any person who does not have the authorization to do so. This includes members of the organization Continued on page 13

Bladder Cancer

Adjuvant Chemoradiotherapy May Provide Benefit in Locally Advanced Bladder Cancer

By Phoebe Starr

I

n the United States, the standard of care for locally advanced bladder cancer after radical cystectomy is to “consider” adjuvant chemotherapy and adjuvant radiation.

Results of a 3-arm randomized clinical trial showed that adjuvant radiation therapy alone or combined with chemotherapy (ie, chemoradiotherapy) did not significantly improve disease-free survival compared with adjuvant chemotherapy alone. However, the findings hint at benefits for chemoradiotherapy that should be studied further. Brian Baumann, MD, a radiation oncology resident at the University of Pennsyl­ vania, Philadelphia, presented the findings at the 2016 Genitourinary Cancers Symposium.

KEY POINTS  Among patients with

locally advanced bladder cancer, adjuvant radiation therapy alone or chemoradiotherapy did not show significant improvement in disease-free survival compared with adjuvant chemotherapy alone  But the results hint at a possible benefit with adjuvant chemotherapy  The disease-free survival rate was 68% in the chemoradiation arm and 63% in the radiation arm  The distant metastasesfree survival rate was 73% for chemoradiation and 72% for radiation

“This is one of the largest trials to be presented, and it provides more evidence that adjuvant chemoradiation may have some benefit in locally advanced bladder cancer.”

—Brian Baumann, MD

The study included 2 main comparisons of adjuvant chemoradiotherapy versus radiation and adjuvant chemoradiotherapy versus chemotherapy alone. The 3-year disease-free survival rate was 68% for adjuvant chemoradiotherapy versus 63% for radiation alone, but this 5% difference was not statistically significant. The 3-year disease-free survival rate in the second comparison was 68% for chemoradiotherapy versus 56% for chemotherapy alone, a numerical trend toward improved survival with chemoradiotherapy.

The rate of local recurrence was significantly reduced with adjuvant chemoradiation versus chemotherapy, which was the only significant difference between the arms in this trial. However, the improved control of local recurrence did not lead to improved disease-free survival or metastasis-­free survival.

The study was conducted in Egypt, where adjuvant radiation therapy is the standard of care for pelvic failure after radical cystectomy. Also, Egyptian patients have more mixed his-

tology, with a higher percentage of squamous-cell bladder cancer than in the United States, explained Dr Baumann. Investigators from the University of Pennsylvania provided help in analyzing and interpreting the data.

“This is one of the largest trials to be presented, and it provides more evidence that adjuvant chemoradiation may have some benefit in locally advanced bladder cancer. Chemoradiation led to improvement in local control in the second randomization. We think the results are intriguing, and larger studies are needed. Four organizations [worldwide] are currently considering such trials adding radiation to neoadjuvant chemotherapy,” Dr Baumann said.

Study Details The study enrolled 198 patients with bladder cancer who were treated between 2002 and 2008 at the National Cancer Institute in Cairo.

The patients were treated with radical cystectomy and pelvic node dissection with negative margins and at least 1 high-risk feature for local failure (ie, stage pathologic T3b disease or higher, grade 3 tumors, and positive lymph nodes).

The patients were aged <70 years (median age, 54 years), had adequate ECOG performance status, and adequate organ function. Patients with evidence of distant metastasis or second malignancies were excluded from the study.

The patients were randomized 3 to 6 weeks after radical cystectomy to adjuvant radiation 45 Gy given twice daily over 3 weeks or chemotherapy with 2 cycles of gemcitabine (Gemzar) plus cisplatin (Platinol),

Bladder Cancer

followed by adjuvant radiation and then by 2 more cycles of gemcitabine plus cisplatin. There were 78 patients in the radiation-alone arm and 75 patients in the chemoradiation arm. A total of 45 patients were later enrolled in the chemotherapy-­alone arm and received 4 cycles of gemcitabine plus cisplatin.

Overall, 53% of patients had urothelial carcinoma, and 41% had squamous-­cell carcinoma. The median follow-up was 19 months.

In the initial randomization, the disease-free survival rate was 68% for the chemoradiation arm and 63% for the radiation arm, a nonsignificant difference. The rate of freedom from local disease-free recurrence was 96% at 3 years with chemoradiation versus 87% for radiation, which was again a nonsignificant difference.

The rate of distant metastases-free survival was 73% for chemoradiation versus 72% for radiation, and the overall survival rate was 64% versus

“Four organizations [worldwide] are currently considering such trials adding radiation to neoadjuvant chemotherapy.”

—Brian Baumann, MD

48%, which were nonsignificant differences.

In the second comparison between chemoradiation and chemotherapy alone, a trend was seen toward im-

proved disease-free survival with chemoradiation versus chemotherapy alone (68% vs 56%, respectively), and a significant benefit was seen for chemoradiation on local recurrence-free survival (96% vs 69%, respectively; P <.001).

No significant differences were found between these 2 arms in patients with 3-year metastasis-free survival (64% for chemoradiation vs 51% for chemotherapy alone) or overall survival; however, the overall survival analysis numerically favored chemoradiation over chemotherapy alone (64% vs 51%, respectively).

“The small size of these arms limits the ability to detect clinically meaningful differences between the chemotherapy and chemoradiation arms,” Dr Baumann said, which is “something that has plagued many adjuvant chemo­therapy trials.” n

Implementing a Robust HIPAA Compliance Program in a Medical... Continued from page 11 who are not authorized to access certain records or other protected health information.

Finally, the information we create, maintain, and store regarding our patients must be available when needed. We must have an upto-date contingency plan in place, and we have to work with a reputable and professional IT group that can monitor and ensure that the confidentiality, integrity, and availability of patient information are maintained.

The HIPAA rules specifically address the need for administrative, technical, and physical safeguards to be put in place, such as: • Administrative: policies and procedures, risk analysis, and awareness and training programs • Technical: identity and access

management, auditing, and network infrastructure safeguards • Physical: facility access management, maintenance record keeping, and workstation security.

A good HIPAA compliance program is more than just a manual or policies and procedures. It is also your documentation and training, as well as your sanctions and safeguards. Your compliance program must be documented, communicated, and enforceable. It is not a program that can be put in place overnight or reviewed one time and then forgotten. HIPAA compliance must become an integral part of the culture of every medical practice, beginning with the administrative or management staff, and then must permeate throughout the entire practice. n

About the Author Angela E. Simmons is a Consultant for Total Medical Compliance (TMC).

TMC is a private consulting company providing programs and seminars for healthcare providers to achieve and maintain compliance with government safety and privacy regulations such as HIPAA, OSHA, and Infection Control. A TMC consultant works in partnership with the safety and privacy officers at your location to ensure all aspects of the regulations are addressed.

TMC provides on-site employee training, customized compliance manuals, office inspections, and ongoing support with newsletters and customer service.

For information on seminar schedules and products, visit www.TotalMedical Compliance.com. For more information, call 888-862-6742 or e-mail Angela@totalmedicalcompliance.com.

FDA News

FDA Approves Fluciclovine F18 Diagnostic Imaging Agent to Detect Recurrent Prostate Cancer

O

n May 27, 2016, the FDA approved fluciclovine F18 (Axumin; Blue Earth Diagnostics) injection, a radioactive diagnostic imaging agent used to detect recurrent prostate cancer.

Fluciclovine F18 injection is indicated for use with positron emission tomography (PET) imaging in patients with suspected prostate cancer recurrence based on elevated prostate-specific antigen (PSA) levels.

“Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels,” said Libero Marzella, MD, PhD, Director of the FDA’s

Center for Drug Evaluation and Research Division of Medical Imaging Products. “Axumin is shown to provide another accurate imaging approach for these patients.”

The FDA approval was based on 2 blinded studies evaluating the safety and efficacy of fluciclovine F18 injection. The first study compared 105 scans using fluciclovine F18 injection with histopathology obtained by prostate biopsy and by biopsies of suspicious imaged lesions in patients with suspected recurrence of prostate cancer. The second study compared the results from 96 scans using fluciclovine F18 injection with C11 cho-

line scans, an approved PET scan imaging test, in men with a median PSA value of 1.44 ng/mL. In both studies, onsite radiologists and 3 independent radiologists read the scans, and their conclusions were generally consistent with one another.

The most frequently reported adverse events were injection site pain, redness, and a metallic taste in the mouth.

Because fluciclovine F18 is a radioactive drug, the FDA recommends appropriate safety measures to limit exposure to patients and providers during administration. n

Tecentriq Receives FDA Approval for Metastatic Urothelial Bladder Cancer

O

n May 18, 2016, the FDA granted accelerated approval to atezolizumab (Tecentriq; Genentech) for the treatment of patients with locally advanced or me­ tastatic urothelial carcinoma who have disease progression during or after platinum-containing chemotherapy, or for those who have had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Atezolizumab received a breakthrough therapy designation in May 2014 for the treatment of metastatic bladder cancer that expresses PD ligand 1 (PD-L1) and was granted a priority review by the FDA for the treatment of locally advanced or metastatic urothelial carcinoma.

The accelerated approval of atezolizumab was based on the results

of the IMvigor 210 study, an open-label, multicenter, single-arm, phase 2 clinical trial of 310 patients with locally advanced or metastatic urothelial carcinoma who received 1200 mg of atezolizumab intravenously.

The study’s primary end point was objective response rate, and the secondary end point was the duration of response.

Atezolizumab conferred at least partial shrinkage of tumor in 9.4% of patients. The objective response rate in the study was 14.8%, and the median duration of response ranged from 2.1 months to 13.8 months.

The objective response rate was 9.5% in patients with PD-L1 expression of <5% and 26% in patients with PD-L1 expression ≥5%, suggesting that the level of PD-L1 expression may help to identify the patients who are more likely to re-

spond to therapy with atezolizumab.

On the same day, the FDA approved the Ventana PD-L1 assay, which is designed to detect PD-L1 levels in the tumor and help clinicians identify patients who would most benefit from treatment with atezolizumab.

The most common (≥20%) adverse events (all grades) associated with atezolizumab included fatigue (52%), decreased appetite (26%), nausea (25%), urinary tract infection (22%), pyrexia (21%), and constipation (21%). The most common (≥2%) grade 3 or 4 adverse events included urinary tract infection (9%), fatigue (6%), abdominal pain (4%), and dyspnea (4%).

Atezolizumab is being evaluated in the confirmatory phase 3 IMvigor 211 study, and is expected to become available for use in June. n

Wealth Management

Choosing a Business Entity for Your Medical Practice Gary S. Sastow, Esq, and Lawrence B. Keller, CFP, CLU, ChFC, RHU, LUTCF

H

ealthcare providers in private practice often ask whether they should form a legal entity. You need to decide if you want to “incorporate,” and to determine which business entity is best for you based on your individual needs and goals. This article will highlight why you should consider forming a legal entity, as well as review some important aspects associated with the most common legal business entities available.

Why Consider Forming a Legal Entity?

Because physicians are personally responsible for their own professional negligence or malpractice, regardless of whether they practice with or without a legal entity, what is the benefit of having one? Although a legal entity does not provide any liability protection from professional negligence or malpractice, it does shield you from liabilities that result from the actions of others.

One example may be a patient who slips and falls in your office and subsequently sues for the injuries sustained.

Rather than being sued personally, the legal entity is sued, and your personal assets are not at risk. Although commercial liability insurance would likely cover such an occurrence, having a legal entity further insulates your personal assets. Other examples may include landlord and tenant disputes, disputes with vendors, and the liability associated with an employee of your practice or another physician or owner of the practice.

Choosing an Entity for Your Medical Practice The type of business entity under

Gary S. Sastow

Lawrence B. Keller

which you can choose to practice normally includes partnerships, corporations, and limited liability companies (LLC). Each category has its own advantages and disadvantages in terms of personal liability protection, tax treatment, flexibility, and administration. For this reason, it is important to review all the details with your attorney and your accountant before making a final decision.

ible by a corporation may not be deductible by a sole proprietorship.

Sole Proprietorship A sole proprietorship is the easiest way to structure your medical practice, because no separate legal entity is actually formed. A sole proprietor’s business is simply an extension of the sole proprietor. Sole proprietors are liable for all business debts and other obligations the business may incur.

This means that your personal assets can be subject to the claims of your business’s creditors.

For federal income tax purposes, all business income, gains, deductions, or losses are reported on Schedule C of your Form 1040. Although a sole proprietorship is not subject to corporate income tax, some expenses that may be deduct-

Partnership In a partnership, 2 or more people form a business for mutual profit.

Therefore, if you are going to own a medical practice with at least 1 other physician, then a partnership is a viable option to consider. However, in a general partnership, all partners have the capacity to act on behalf of one another and with full authority on behalf of the practice. This also means that each partner is personally liable for any acts of the others, and all partners are personally responsible for the debts and liabilities of the practice.

It is not necessary that each partner contributes equally to the practice or that all partners share equally in the profits, which will be reflected in the partnership agreement. In fact, in most businesses it is not uncommon for one partner to contribute a majority of the capital while another contributes the business acumen or contacts, and for the 2 partners to share the profits equally.

Although a partnership is a recogContinued next page

Wealth Management

Choosing a Business Entity for Your... Continued from page 15 nized legal business entity in the sense that the entity can obtain credit, file for bankruptcy, and transfer property, among other things, a partnership is not itself a taxpaying entity and, generally, only files an information income tax return (Form 1065). Each partner receives a Schedule K-1 from that return (the income, gains, deductions, and losses of the partnership), and then reports the information from the Schedule K-1 on Schedule E of Form 1040.

S Corporation An S corporation is formed by filing Articles of Incorporation with the state. The election of S corporation status is made by filing with the Internal Revenue Service (IRS; Form 2553), making a state-level S corporation election after incorporating your business, and the decision must be unanimous among shareholders. An S corporation is a corporation that has made an election to have its income, deductions, capital gains and losses, charitable contributions, and credits passed through to its shareholders.

To a great extent, an S corporation is treated for tax purposes like a partnership. However, the S corporation retains some features of the corporation, such as limited liability of shareholders. S corporations also require some operational formalities, including regular meetings of shareholders and a board of directors, written minutes of those meetings, and corporate resolutions authorizing certain actions.

Generally, an S corporation only files an information income tax return (Form 1120S); each shareholder receives a Schedule K-1 from that return (for the income, gains, deductions, and losses of the S corporation) and reports the informa-

tion from the Schedule K-1 on Schedule E of Form 1040. Without an S corporation election, the business will be taxed as a C corporation. Although the business may consist of many owners, it is considered a single entity that is separate from the owners.

Although a legal entity does not provide any liability protection from professional negligence or malpractice, it does shield you from liabilities that result from the actions of others.

An S corporation must be a domestic corporation and must not have more than 10 shareholders.

Although an S corporation may have only 1 class of common stock, IRS regulations have permitted S corporations to issue voting stock and nonvoting stock. Both kinds of stock, however, must have the same rights with regard to allocation and distribution of earnings. The S corporation is also attractive because income is only taxed once, not twice, as is the case with a C corporation. The corporate alternative minimum tax and the tax on unreasonable accumulations of income also do not apply.

Generally, if you are a shareholder physician, you are paid as an employee of the practice with a W-2 form, and as an owner of the practice via a K-1 distribution. The main difference is that you pay Medicare

and Social Security tax on W-2 income but not on K-1 distributions.

Although the large Social Security portion of the Federal Insurance Contributions Act phases out after you reach an income of $118,500 (for 2016), the 2.9% Medicare tax has no phase-out. Wages of more than $200,000 that are earned in 2016 will face an extra 0.9% Medicare tax, which will be withheld from employeesâ&#x20AC;&#x2122; wages (employers are not responsible for this additional tax). In addition, qualified retirement plan contributions are limited by the W-2 income for the S corporation owner.

The consensus among experienced certified public accountants is that the W-2 â&#x20AC;&#x153;salaryâ&#x20AC;? must be reasonable. This is the amount that you could earn if you worked somewhere else in a similar capacity. The remaining amount would then be paid as a distribution to avoid paying Social Security and Medicare taxes on that income.

Generally, S corporations are also audited less frequently than sole proprietorships.

C Corporation A C corporation is formed by filing Articles of Incorporation with the state. C corporations require a great number of operational formalities, including bylaws, regular meetings of shareholders and a board of directors, written minutes of those meetings, and corporate resolutions authorizing certain actions.

A C corporation is owned by its shareholders, who elect a board of directors, which is responsible for managing the business. The board, thus, elects officers to run the company. The shareholders are investors who contribute cash, property, or services for their stock, and their lia-

Wealth Management

bility for the corporation’s debts and obligations is limited to the amount of their investments. C corporations can also have several classes of stock (common stock and preferred stock are good examples).

C corporations pay taxes at the entity level. They file a corporate tax return (Form 1120) and pay taxes at the corporate level, and then may distribute the remaining earnings as dividends to the owners.

The dividends are not deductible to the corporation, and are income for the owners of the corporation.

Therefore, a C corporation is subject to double taxation on earnings.

The double taxation of corporate earnings was reduced by the Jobs and Growth Tax Relief Reconciliation Act of 2003, which made dividends taxable at the same rate as capital gains.

Limited Liability Partnership Most states allow professionals, such as physicians, lawyers, and accountants, to form an entity similar to the LLC. A limited liability partnership (LLP) is a general partnership that is managed by its partners and is taxed like a partnership, but the partners’ liability for any professional malpractice of other partners is limited to partnership assets.

The partners of an LLP have more liability protection than partners of a general partnership, but they still have unlimited personal liability for obligations of the practice.

To form an LLP, the partners must file a form with the secretary of state, and annual renewal of registration is required to maintain the protection from liability. The name of the business entity must include a designation that it is an LLP (ie, LLP or LP must appear in the name).

Limited Liability Company An LLC is formed by filing Articles of Organization with the state, and all members must sign an oper-

ating agreement. The members contribute cash, property, or services, and income is apportioned according to the contributions of the members. The name of the business entity must include a designation that it is an LLC (ie, LLC or LC must appear in the name). As a default, the LLC is taxed as a partnership or sole proprietor.

One example may be a patient who slips and falls in your office and subsequently sues for the injuries sustained.

Rather than being sued personally, the legal entity is sued, and your personal assets are not at risk.

The LLC must elect to be treated as a corporation. Unlike an S corporation, an LLC permits unequal allocation of profit and loss, while affording the same limited liability that the equity owners receive when organized as a corporation. Unlike partners in a limited partnership, all LLC members can take an active role in the operation of the business without exposing themselves to personal liability. In California, professionals are not allowed to form an LLC or a professional LLC, and instead must form a professional corporation or a registered LLP.

Professional Corporation A professional corporation, sometimes known as a qualified personal service corporation, is a special type of corporation composed of professionals who require a license to practice. Under the tax code, a qualified

personal service corporation is defined as a corporation formed under state law in which substantially all of the activities involve services in the fields of health, law, engineering, accounting, actuarial science, performing arts, or consulting.

To form a professional corporation, you must file Articles of Incorporation with the secretary of state and pay a filing fee. Compared with an ordinary corporation, which may be formed for any lawful purpose, a professional corporation’s articles must limit its corporate purpose to the practice of the profession that its shareholders are licensed to perform.

Unlike ordinary corporations, professional corporations must usually also obtain approval from the state professional licensing board that regulates the profession. The state licensing board will ensure that all shareholders are licensed professionals in good standing. Such corporations must also identify themselves as professional corporations (by including PC or P.C. after the firm’s name).

Although most state laws forbid professionals from forming regular corporations, the urge to incorporate reflects a desire to take advantage of Internal Revenue Code provisions that grant more generous deductions or other tax benefits to corporate employee benefit plans than to similar plans created by self-employed individuals. The owners of a professional corporation are its shareholders, who perform services for the corporation as employees.

The IRS imposes 2 tests to ensure that a corporation under state law qualifies as a personal service corporation. These tests focus on what the corporation does (the “function test”) and how it is owned (the “ownership test”). If a professional corporation does not qualify as a personal service corporation, then it is generally treated under the tax code as a C corporation. Keep in Continued next page

Wealth Management

Choosing a Business Entity for Your... Continued from page 17 mind, however, that a professional corporation can elect to be treated for tax purposes as an S corporation.

The tax treatment will largely depend on how much of the outstanding stock is owned by employee shareholders. In general, however, a professional corporation is a separate entity from its owners, similar to a C corporation. Therefore, it must file its own corporate tax return annually, and it may offer many of the fringe benefits available to C corporations. As noted, however, a professional corporation can elect to be treated as an S corporation.

Qualified personal service corporations must use a calendar tax year, unless a business purpose for a fiscal year is established and they are not taxed at the same graduated rates that apply to C corporations. Rather,

professional corporations are taxed at a flat 35% rate on their taxable incomes. Professional corporations are subject to the passive activity loss rules and the at-risk rules. For more information regarding these rules, be sure to speak with your accountant and attorney, because it is beyond the scope of this article.

Conclusion There is no single best form of ownership for a business. This article provides a brief overview of the most common legal entities available and highlights some important aspects associated with each. You should consult with your attorney and accountant to weigh the pros and cons of each type of legal business to determine which best meets your individual needs and goals. After you

have chosen your entity, be prepared to reassess your situation as your practice evolves and your personal circumstances change. n Gary S. Sastow, Esq, is a partner in Brown, Gruttadaro, Gaujean & Prato, PLLC, a New Yorkâ&#x20AC;&#x201C;based law firm providing legal services to healthcare professionals and other business owners.

He can be reached at 914-949-5300 or by e-mail at gsastow@bggplaw.com with comments or questions.

Lawrence B. Keller, CFP, CLU, ChFC, RHU, LUTCF, is the founder of Physician Financial Services, a New Yorkâ&#x20AC;&#x201C;based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached at 516-677-6211 or by e-mail at Lkeller@physicianfinancialservices. com with comments or questions.