chesapeake physician january/february 2016

chesphysician.comVOLUME 6 ISSUE 1 JANUARY/FEBRUARY 2016

Reducing Cardiovascular RiskPROACTIVE APPROACHES FOR TREATING

DIABETES

THE RISE OF DIRECT PRIMARY CARE

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CONTENTS

10Reducing Cardiovascular RiskCardiovascular experts discuss how new guidelines to lower blood pressure, improving transcatheter aortic valve replacement and implantable monitoring of arrhythmias after cryptogenic stroke are reducing risk and improving lives.

16Proactive Approaches for Treating DiabetesSome 29 million Americans have diabetes, although a decline in the incidence of new cases since 2009 provides hope for progress. Our medical experts discuss how technology can be harnessed to provide better monitoring and care, the role of wound care centers, and effective treatments for lower-extremity ulcers.

F E A T U R E S D E P A R T M E N T S

6 CASESPreventing Amputation With Surgical Foot Reconstruction

8 SOLUTIONSHow Credit Reporting Changes Affect Your Practice’s Bottom Line

22 HEALTHCARE ITThe Rise of Direct Primary Care

25 COMPLIANCE Enhancing Your Medical Practice With Telehealth Services

28 POLICYMaryland’s Newest Medicine: Medical Cannabis

31 OUR BAY

ON THE COVER: Henry Tran, MD, cardiologist, INOVA Fairfax Hospital

4 l CHESPHYSICIAN.COM

Jacquie Cohen RothFounder/Publisher/Executive [email protected] @chesphysician

n 2014, the Affordable Care Act expanded health coverage to millions of Americans. In 2015, healthcare spending in the U.S. grew an average of six percent each quarter. In 2016, the demand for healthcare services will continue to rise as more people have insurance. Along with the increased demand for services, you’re

also experiencing increased pressure to deliver high quality patient care. Thankfully, there are a growing number of innovative technologies to help with both clinical care and practice management.

In every issue of Chesapeake Physician, we highlight the latest advancements in clinical care and how that care is delivered, with the goal of providing compelling content that helps you provide better, more efficient diagnosis and treatments. In this issue’s clinical focus, we present advances in cardiovascular disease (p. 9) and commodity, diabetes (p. 6 and 16).

Our medical experts cover the exciting news on lowering hypertension from the results of the early terminated SPRINT trial; better detection of A-fib to prevent strokes; and the increasing success of a less invasive approach to aortic valve replacement.

In this issue, we also explore a disruptive business model called direct primary care (DPC), which allows primary care physicians to delivery services without billing payers. We spoke with spoke with two Chesapeake-based primary care physicians who shifted from the fee-for-service practice model to DPC (p. 22), taking advantage of advances in healthcare information technology to help your patients stay healthier. The access to continues care enhanced by the use of technology means better management of chronic disease (p. 25), and that means that lower costs – across the board.

Paradoxically, Maryland’s recent innovative inclusion of a controversial treatment option is gaining momentum with the legalization of medical cannabis (p. 28). We explore what this development means for Maryland physicians and their patients.

I hope you’ve noticed our enhancements to the design of the following pages, and in the coming weeks, our digital platform. It’s our goal to make sure our content compelling and inspiring via a multi-dimensional delivery in both print and digital. As always, please let us know we’re hitting the mark, along with how and what you’d like to read.

To Life!

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JANUARY/FEBRUARY Cover Story: Reducing Cardiovascular RiskFeature: Proactive Approaches for Treating DiabetesHIT: Direct Primary Care Model - An Alternative to Fee-for-Service

MARCH/APRIL

Cover Story: Digestive Disease Update Feature: Treating Obesity Comorbidities HIT: Connected Health & The IoT

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In Every Issue and OnlineCases l Solutions l Compliance l Policy

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CASES

Preventing Amputation With Surgical Foot Reconstruction BY NOMAN A. SIDDIQUI, DPM, MHA

DISCUSSION: Diabetic foot ulcers are one of the most common complications associated with patients with a history of diabetes. Studies show that 25 percent of diabetics will eventually develop a foot ulcer.1 It forms in a diabetic patient as a result of neuropathy, peripheral arterial disease or pressure. In many cases, it is a combination of these factors that cause the ulceration and prevent it from healing.

Non-healing ulcers or wounds present a significant medical challenge since studies have shown that 50 percent of diabetic foot wounds become infected and can lead to amputation at higher rates.2 Diabetic patients who undergo amputation have a much higher mortality rate than those without diabetes. These statistics are alarming, since the American Diabetes Association estimates 30 million

people in the United States have diabetes.3 Numerous studies have shown that the direct cost of treating chronic diabetic wounds has increased to $13 billion in the United States annually.4

These statistics highlight the significant medical and public health burden that diabetic foot wounds pose to the population. The treatment to heal chronic foot wounds in a diabetic population is a multi-disciplinary effort requiring medical and surgical specialists. The Diabetic Limb Preservation team focuses on healing chronic non-healing diabetic foot wounds using advanced surgical and medical technology.

External fixation is one of the many surgical methods that are used when treating chronic wounds. Each patient is assessed for the specific cause that is contributing to a delay in healing and treated accordingly. Ultimately, wound healing has many factors. In the right patient, surgical reconstruction of the foot can be a powerful and effective method to prevent amputations associated with diabetic foot wounds. However, the goal for physicians must be on diabetes management and prevention so as to avoid the multiple systemic consequences that are associated with this terrible disease. CP

CASE

Noman A. Siddiqui, DPM, MHA, is division chief of Podiatry at Northwest Hospital, Randallstown, Md., and medi-cal director, Diabetic Limb Preservation at LifeBridge Health. He can be reached at [email protected].

n

A 60-year-old female with a history of Type 2 diabetes, neuropathy and high blood pressure related that she had developed a non-healing sore after she noticed her “arch collapsed” a year earlier. She had seen multiple doctors but had not had any success healing her open wound. She was seen by the diabetic limb preservation team following her hospital admission for a foot infection. She explained that she had been told that having her leg amputated was a very real possibility if her wounds would not heal.Reviewing her radiographs revealed that she had developed Charcot Joint

in her ankle – a condition that can develop in patients with a positive history of diabetes and neuropathy, resulting in a loss of stability in the bones of the foot. Over time, the bones fracture and lose their normal shape, which results in pressure to the skin from uneven distribution of the individual’s body weight. After controlling the infection, the patient was given the option to heal her wounds surgically, since they had failed to heal using other methods over the course of a year. An Ilizarov external fixation device was used to treat the complex foot

wound. This device is a system consisting of rings and pins that is applied externally to a patient’s extremity. The device offloads the wound while simultaneously fusing the joints that are unstable. She underwent treatment for three months until the wound was healed and her unstable bones fused and achieved stability. At the end of this treatment, the patient had no open wounds and was able

to ambulate in a supportive diabetic shoe. She continues to be seen for routine followup, and has not developed a new ulceration. She was thankful that the diabetic limb preservation team was able to save her leg from amputation.

1 Singh, Armstrong, Lipsky. J Amer Med Assoc 20052 Lavery, Armstrong, et al. Diabetes Care 2006

3 Diabetesatlas.org/American Diabetes Association 4 Rice, Desai, et al. Diabetes Care. 2014; 37:651-658



Save the Date Saturday, April 16, 2016

Meyerhoff Symphony Hall Baltimore, Maryland

Daniel Klein and Howard Perlow, Gala Co-Chairs

For more information, visit LifeBridgeHealth.org/Gala2016

or call 410-601-4438.

Advancing the Future of Health Care

SOLUTIONS

How Credit Reporting Changes Affect Your Practice’s Bottom LineBY ANTHONY CARABELLO AND ALI BECHTEL

V arious regulatory changes within the credit reporting industry

will soon begin to have an effect on your practice’s receivables. Understanding them and ensuring compliance is key to maintaining recovery. These updates are a result of the Consumer Financial Protection Bureau’s (CFPB) civil investigations into credit bureaus and their high-volume data furnishers. The CFPB is focused on the number and types of disputes filed by consumers, and the accuracy of data reported to the bureaus. Recently it has filed a multi-million-dollar enforcement action against one such furnisher and has been steadily adding regulations to give consumers further protection from negative credit reports.

Your Practice Must Investigate Disputes Within 30 Days

In 2013 and 2014, the CFPB established a series of mandates making it the data furnisher’s duty to conduct an in-depth investigation of all disputes within 30 days. The review must include any supplemental information provided by the Bureau as well as all information provided by the patient since the date of service in question.

Whether your practice has partnered with a third-party collection agency or handles its own credit reporting, this means more work for your office staff. If you are working with an agency, it is essential to develop a policy for communication and support in order to conduct these investigations thoroughly, and in a timely manner. It is also more important than ever that payments are posted promptly, so that paid accounts can be removed from the patient’s credit report right away.

Delinquent Patients May Have Lesser Consequences

In the midst of the CFPB’s investigations, FICO announced its newest scoring model, FICO 9. The announcement came just months after a CFPB study indicated that people with medical debt were over-penalized on their credit reports as a result of third-party payer delays and denials. The new model devalues medical debt when determining a credit score, and disregards paid collection agency accounts altogether.

While this model has not yet been widely adopted, major lenders are using it when deciding whether to extend credit, and as it becomes accepted throughout the lending industry, it could result in an even higher amount of self-pay accounts going uncollected. Patients with outstanding balances are motivated to pay when the debt affects their ability to secure further credit. Under this model, the consequences for delinquent patients are much smaller. Coupled with increasing difficulty in credit reporting, your practice may have to consider legal action as the best recourse for collecting outstanding balances in the future.

National Consumer Assistance Plan Makes Auditing, Updating Collection Policies Critical

The National Consumer Assistance Plan was launched in March 2015 as a result of an agreement between New York Attorney General Eric Schneiderman and the nation’s three leading credit reporting agencies – Experian, Equifax, and TransUnion – following an investigation

into complaints regarding erroneous reports, identity theft and fraud. Since the plan’s implementation, 31 other states have joined New York in its adoption.

The plan includes medical debt reporting reforms aimed at reducing derogatory remarks resulting from insurance payment delays and disputes. As of June 8, 2018, the bureaus are implementing a 180-day waiting period from the date of first delinquency for reporting medical debt. This means your receivables must age longer, decreasing the likelihood of payment, before they can be reported. As a result, your practice should be vigilant about beginning collection activity on unpaid accounts as early as your financial policy allows. Additionally, by this date, agencies will also be required to remove all medical bills that have been paid by insurance from a patient’s credit report.

The CFPB has clearly established itself as the industry watchdog. As a result, it may become more difficult for physician practices to find third-party agencies that are willing to report, and those that do may increase their rates to compensate for the added risk. However, reporting can still be a useful tool as long as your practice is compliant. Best practices suggest that, in order to maintain compliance, you should review and update collection policies and procedures, and continually audit them to ensure they meet with these ever-changing standards. It is more important than ever to develop a strong relationship with your agency to ensure you do not run afoul of these mandates, but also do not compromise recovery. CP

Anthony Carabello, CEO & founder of AR Logix, Inc., can be reached at [email protected] and Ali Bechtel, PR & marketing coordinator, can be reached at [email protected].



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A SPRINT TO LOWER BLOOD PRESSUREIt’s not often that clinical studies create such clear results as the Systolic Blood Pressure Intervention Trial (SPRINT), terminated early in the fall of 2015 when its results demonstrated the cardiovascular benefits of lowering systolic blood pressure to 120 mm Hg instead of the standard target of 140 mm Hg. The trial population consisted of over 9,300 non-diabetic adults age 50 and older that had elevated risk for heart disease.

The prevalence of hypertension continues to rise in the U.S. According to the CDC, as in 2011/12, 32.5 percent of adult Americans had hypertension. Fortunately, awareness of this ‘silent disease’ has risen significantly in the past decade, with 83 percent aware of their hypertension, 76 percent taking medications and 52 percent controlling it as of 2011/12.

“The bad news is that the incidence of hypertension is increasing across the world, not just here in the U.S., correlating with a sedentary lifestyle, more processed foods and higher obesity rates,” says Henry Tran, MD, a cardiologist at INOVA Fairfax Hospital in Fairfax, Va.

SPRINT RESULTSAchieving the SPRINT results was not without drawbacks. It

required using a combination of three medications on average – rather than the standard two – and put participants at greater risk for some adverse events such as hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure.

Nonetheless, those with more aggressive treatment experienced a 25 percent reduction in the composite outcome of myocardial infarctions, acute coronary syndromes, stroke, heart failure, and CV death. Dr. Tran says, “The SPRINT results were received with enthusiasm at American Heart Association Scientific Sessions. SPRINT was a well done study involving more than 90 academic

Cardiovascular experts discuss how new guidelines

to lower blood pressure, improved transcatheter

aortic valve replacement and implantable monitoring of

arrhythmias after cryptogenic stroke are reducing risk and

improving lives.

ReducingCardiovascular

RiskBY LINDA HARDER

PHOTOGRAPHY BY DEAN RAY AND TRACEY BROWN

ABOVE: Henry Tran, MD, a cardiologist at INOVA Fairfax, talks with a patient about the

latest treatment approaches for hypertension. OPPOSITE PAGE: Henry Tran, MD


and community practices across the country, so the results are generalizable. The protocol was strategically oriented and was not beholden to any specific drug class.”

He continues, “There was a statistically significant decrease in deaths related to cardiac disease and heart failure rates (43 percent and 38 percent, respectively), but not a decrease in myocardial infarcts or strokes, which was somewhat surprising. Five years previously, the ACCOMPLISH trial suggested that a combination of ACE inhibitors and calcium channel blockers might

be superior. This study used those two drug classes, as well as thiazide diuretics and spironolactone.”

“Interestingly, Caucasian men aged 75 and older without overt heart or kidney disease benefited the most,” notes Dr. Tran. “A pre-specified subgroup analysis showed that African Americans, women and younger patients did not have a significant benefit. And importantly, these results do not pertain to patients with diabetes.”

“It took an average of 1.9 drugs to achieve 140 mm Hg, and about three drugs to achieve 120 mm Hg,” he explains. “The paradigm among cardiologists has shifted to using multiple drugs at moderate doses to treat those with hypertension, rather than a single drug at a higher dose. I recommend that in patients with systolic blood pressures above 150 mm Hg, physicians start with using two drugs and increase to three if needed.”

Dr. Tran acknowledges that patient compliance can be an issue when patients are taking more medications. “Even the best trials have 50 to 60 percent dropout rates after one year.”

“SPRINT was a well done study involving more than 90 academic and

community practices across the country, so the results are generalizable.”

– HENRY TRAN, MD

Anuj Gupta, MD, an interventional cardiologist at the University of Maryland Medical Center


LIFESTYLE CHANGES CONTRIBUTEDr. Tran also urges patients with hypertension to

exercise more and to eat far fewer processed and canned foods, as these contain excessive sodium. He has found that many patients don’t realize just how much sodium they contain. “The battle is already lost when they open a can of soup,” he says. “And eating one hot dog provides 1,000 mgs of sodium. The DASH sodium trial found that hypertension can be decreased nine to 10 points by consuming less sodium. Several small studies found that exercise offered benefits to blood pressure and heart disease.”

EVOLVING CHOLESTEROL TREATMENTSSeveral studies have shown that dietary cholesterol

has minimal impact on cardiovascular risk. In late 2014, the Dietary Guideline Advisory Committee announced that dietary cholesterol is no longer a “nutrient of concern for overconsumption.” However, saturated fats and sugar remained on the list of substances to consume with caution. The American Heart Association recommends saturated fat calories represent six percent or less of total calories. Dr. Tran predicts that trans fats will be banned from the food chain within the next three years.

With FDA approval of a second PCSK9 inhibitor in fall 2015, cardiologists possess a new option for reducing LDL cholesterol. Dr. Tran notes, “The 2013 ACC/AHA Guidelines abandoned specific LDL targets for treatments. The guidelines were very focused on statin therapy and largely relegated all other therapies to second-line treatments. However, since then we have seen positive trials using ezetimide and the new PCSK9 inhibitors. I think with these new medications, cardiologists will be more inclined to target specific LDL goals now.”

The largest complaint among those taking statins is muscle aches, with 15 to 20 percent complaining of this side effect. Memory problems are another complaint, but there is no clear link to dementia, and one in 300 people are at risk for chemical diabetes. Dr. Tran recommends trying patients on several different statins.

He adds, “Today, we’re excited about evolocumab and alirocumab. PCSK9 inhibitors are a fascinating new therapeutic class that can decrease serum LDL an additional 60 percent by dysregulating the LDL receptors in the liver. However, studies with hard clinical endpoints have not yet been published. Early results from one study suggest a 50-percent drop in heart attacks, but the question is where these fit in.

They cost over $10,000 per year, and it’s not clear insurers will pay. They may be appropriate for those who fail statins, but likely won’t be used as first-line therapy.”

TAVR: VIABLE ALTERNATIVE FOR SEVERE AORTIC STENOSIS

Transcatheter Aortic Valve Replacement (TAVR) has been validated in a number of studies as a viable alternative for those with severe aortic stenosis considered high risk for open-heart surgery.

These procedures have come a long way since the first TAVR procedure in humans was performed in France in 2002, thanks to evolving technology and training. The first-generation devices used in TAVR were found to be vastly superior to doing nothing in inoperable patients, and similar to open-heart procedures in high-risk patients.

Anuj Gupta, MD, an interventional cardiologist at University of Maryland Medical Center and director of the Cardiac Catheterization Laboratory at the University of Maryland School of Medicine, explains, “In the earlier years, we didn’t know how to size the valves well and the devices were bulky. There was a lot to be learned.”

A growing body of evidence supports the value of TAVR in high-risk populations. In October 2010, a New England Journal of Medicine (NEJM) article reported the findings of the PARTNER (Placement of Aortic Transcather Valves) trial. This prospective, randomized trial was designed with two arms: PARTNER A, which consisted of 699 participants that were deemed high risk for surgery, and PARTNER B, which assessed 358 patients considered inoperable. Results of this study demonstrated good survival rates with TAVR but a high risk for stroke and perivalvular leakage with the balloon-expandable Edwards SAPIEN THV in use at the time.

NEWER GENERATION DEVICESMedtronic developed a second approach to aortic

valve replacement called CoreValve®, which used nitinol, a memory metal that expands to its intended shape within the aortic annulus. Dr. Gupta explains, “The two valves are probably similarly effective, but the Medtronic device has a substantially greater need for pacemakers.”

By May 2014, a Medtronic study published in the NEJM found that TAVR resulted in a lower rate of mortality (14.2 percent) than surgery (19.1 percent)

“Today’s TAVR is appropriate for patients with severe stenosis who are at high risk for surgery or ineligible for surgery.” – ANUJ GUPTA, MD


in 795 patients with severe aortic stenosis. The risk of bleeding events and acute kidney injury also was lower in TAVR, but these patients did experience a higher rate of major vascular complications.

Manufacturers continue to develop newer-generation valve systems to improve valve positioning and reduce aortic regurgitation (AR). “Both the SAPIEN 3 and Evolute have decreased the size of their delivery systems and reduced paravalvular leak,” notes Dr. Gupta. “The biggest intermediate-term failure from the early devices was moderate to severe valve leakage, which has been addressed with design changes to these valves.”

APPROPRIATENESS CRITERIA ARE EVOLVING“Today’s TAVR is appropriate for patients with severe

stenosis who are at high risk for surgery or ineligible for surgery,” Dr. Gupta states. “We await data from completed trials on intermediate-risk patients, and we eventually will have trials for low-risk patients. With TAVR, we can get patients home in two to three days and back to life in a week, versus a month to recover from open heart surgery.”

He adds, “The TAVR valve costs $30,000 to $35,000, while a standard valve costs only $4,000 to 5,000. Formal cost-effectiveness analysis suggests that TAVR from the groin is cost-effective compared to SAVR in these high-risk patients.”

Patients are seen by Dr. Gupta in conjunction with an experienced cardiac surgeon and a nurse practitioner to ensure that the most appropriate approach is undertaken for that individual. “We perform a frailty test, a quality-of-life and other tests to determine their baseline, and then we repeat these tests after their procedure,” Dr. Gupta explains.

To track the safety and efficacy of TAVR, the Society of Thoracic Surgeons and the American College of Cardiology have created a registry to document outcomes for these new and emerging procedures. This registry will provide better data for those undergoing the procedure in the future.

PREVENTING STROKE IN THOSE WITH AFA relatively new implantable cardiac loop recorder

(ILR) the size of an AAA battery is replacing the old paradigm for treating people following a cryptogenic stroke (one with unexplained etiology). Those with atrial fibrillation (AF) have a greater risk of stroke, and physicians estimate that 25 to 40 percent of unexplained strokes are caused by AF.

Given that the incidence of AF has been predicted to double in the next 40 years, and that patient awareness of this problem is dismally low, better tools to detect it are key to preventing many first and second strokes.

“Patients suffering a cryptogenic stroke sometimes

return three months later with a second stroke and in atrial fibrillation. We can do better,” says Brett Roberts, MD, an electrophysiologist at University of Maryland St. Joseph Medical Center.

Until recently, the standard of care for those with a cryptogenic stroke involved using a telemetry monitor for 24 to 48 hours and a carotid ultrasound. However, the CRYSTAL AF Study, reported in the NEJM in June 2014, compared the ability of a Holter monitor with an ILR to detect AF and found that the ILR was 8.8 times more likely to detect AF over three years. AF was detected in an astonishing 30 percent of those receiving ILR.

This diagnostic tool is key to appropriate patient management to prevent second strokes. “Failing to detect a high percentage of atrial fibrillation, the greatest cause of these cryptogenic strokes, patients would be discharged to home on a baby aspirin and a statin,” explains Dr. Roberts. “Detecting AF significantly changes the management of over 90 percent of these patients, most of whom are asymptomatic and don’t know they have it.”

Electrophysiologists implant ILR devices under the skin to provide up to three years of continuous monitoring of cardiac rhythms. Dr. Roberts notes, “This tiny device continuously records every heart rhythm, then transmits the data to a box under the patient’s bed. That box sends a cellular signal to the physician’s office to alert the physician if there are any abnormalities. It has a 97 percent sensitivity for detecting A-fib.”

He explains, “It’s an outpatient procedure not requiring sedation that I perform in the EP lab, implanting it under the skin in the left chest wall at about nipple height, close to the sternum. Closing the tiny incision requires only a bit of surgical glue.”

The device, which can be worn while undergoing an MRI, also detects supraventricular tachycardia, intermittent heart palpitations or syncope. “Further, the device is valuable for those presenting with a transient ischemic attack (TIA) in either the internist’s office or the hospital, not just those with a stroke,” says Dr. Roberts, who performs about 60 of these procedures per year.

The ILR is also useful to monitor those with infrequent syncope or palpitations, or those following AF ablation.

“Patients suffering a cryptogenic stroke sometimes return three months later with a second stroke and in atrial fibrillation.”

– BRETT ROBERTS, MD


MORE SOPHISTICATED ANTICOAGULATION MANAGEMENTt

In addition to needing better detection of AF, more sophisticated management is also warranted. According to a recent systematic review reported in the American Journal of Medicine in 2010, supported by a similar finding in a study reported in Stroke in 2009, anticoagulants are significantly underused in this at-risk population.

Oral anticoagulant therapy reduces the risk of stroke and all-cause mortality, but also increases the risk of serious bleeding complications. “With anticoagulation, we’re constantly weighing the risks of hemorrhaging against the risk of stroke,” says Dr. Roberts.

Older data indicated that the major risk factors for stroke in patients with AF are previous stroke or transient ischemic attack, increasing age, hypertension, heart failure, and diabetes mellitus. Newer data also has identified female sex, age of 65 to 74 years, and vascular disease as other risk factors. As a result, the earlier CHADS2 risk score for stroke was refined to result in the more comprehensive CHA2DS2-VASc Score.

The CHA2DS2-VASc scores range from 0 to 9, assigning points for those with heart failure or ejection fraction < 35, hypertension, age > 65, female sex, vascular disease, and diabetes. Generally,

anticoagulation is recommended for the average patient with a CHA2DS2-VASc score ≥2 unless contraindicated due to clinically significant bleeding, a history of falls or other factors.

Researchers created a second algorithm to determine bleeding risk, called the HAS-BLED score.

The HAS-BLED assessment tool assigns one point to each of the risk factors for bleeding represented in its acronym: Hypertension >160 mm Hg, Abnormal renal and/or liver function, previous Stroke, Bleeding history or predisposition, Labile international normalized ratios, Elderly, and Drug and/or alcohol excess. Patients with a score ≥ 3 are recommended to undergo regular clinical evaluation after starting on oral anticoagulants.

Dr. Roberts notes that, together, these risk scores provide a more nuanced and useful approach to balancing the risks and benefits of intervention with anticoagulants. CP

Brett Roberts, MD, an electrophysiologist at University of Maryland St. Joseph Medical Center

Henry Tran, MD, a cardiologist at INOVA Fairfax HospitalAnuj Gupta, MD, an interventional cardiologist at University of Maryland Medical Center and director of the Cardiac Catheterization Laboratory at the University of Maryland School of MedicineBrett Roberts, MD, an electrophysiologist at University of Maryland St. Joseph Medical Center


“Patients like telehealth for diabetes education with a nurse and a nutritionist, but … they don’t want to use it for physician visits.” – GAIL NUNLEE-BLAND, MD, FACE, FAAP


DIABETESProactive Approaches for Treating

BY LINDA HARDER

PHOTOGRAPHY BY TRACEY BROWN

HARNESSING MOBILE TECHNOLOGY

Gail Nunlee-Bland, MD, FACE, FAAP, chief of Endocrinology and director of the Diabetes Treatment Center at Howard University Hospital, is an inspiring leader who has embraced the use of mobile technology to improve the health of patients with diabetes. Under her leadership, the Center has experimented with telehealth, patient health portals and smartphone apps to enhance patients’ involvement in their care.

“Technology is helping us better coordinate the care for this systemic disease that involves multiple caregivers,” Dr. Nunlee-Bland explains. In 2008, the Center embarked on a pilot program to monitor diabetics with poor control of their disease on a weekly basis. They provided online education via a patient portal and notified the primary care physician when the patient’s level became problematic.

“This program did help to make a significant decrease in A1C levels, blood pressure and weight,” acknowledges Dr. Nunlee-Bland, “but it was very expensive.” The Center revamped the program and is currently seeking to expand it to reach an urban population.”

EDUCATION IS CRITICAL

In October 2015, the U.S. Preventive Services Task Force recommended screening for abnormal glucose in overweight or obese adults aged 40 to 70 years and referrals for those with abnormal glucose to intensive behavioral interventions to promote a healthful diet and physical activity. Modifying lifestyle based on screening results, with multiple contacts over time with providers, was key to making this recommendation effective.

The panel also found evidence that behavioral interventions were more effective than medications for those with impaired fasting glucose or impaired glucose tolerance.

Dr. Nunlee-Bland concurs that behavioral intercessions are invaluable. She says, “Diabetes educators are often better than physicians at setting behavioral goals for patients, and those who go through education often do better than those who just take

SOME 29 MILLION

AMERICANS HAVE DIABETES,

ALTHOUGH A DECLINE IN

THE INCIDENCE OF NEW

CASES SINCE 2009 PROVIDES

HOPE FOR PROGRESS. OUR

MEDICAL EXPERTS DISCUSS

HOW TECHNOLOGY CAN

BE HARNESSED TO PROVIDE

BETTER MONITORING

AND CARE, THE ROLE

OF WOUND CARE

CENTERS, AND EFFECTIVE

TREATMENTS FOR LOWER

EXTREMITY ULCERS.

OPPOSITE PAGE: Gail Nunlee-Bland, MD, chief of Endocrinology and

director of the Diabetes Treatment Center at Howard University Hospital,

uses technology to fight diabetes.


medication. I’ve found that patients can out-eat and under-exercise any medication I give them.”

Dr. Nunlee-Bland notes that portion size is one of the greatest gaps in the public’s understanding. She says, “In general, people know what’s bad for them, but their eyes get big when I show them proper portion sizes.”

APPROPRIATE USE OF TELEHEALTH, PORTALS

“Our focus groups revealed that patients like telehealth for diabetes education with a nurse and a nutritionist, but that they don’t want to use it for physician visits,” Dr. Nunlee-Bland says.

The Center also developed a personal health record portal, available via computer, tablet or smartphone, to help patients manage their diabetes and share information with caregivers.

Dr. Nunlee-Bland recalls, “Patient feedback in the focus groups indicated that they didn’t want to use the portal for education as much as they wanted to be able to ask questions of their physicians and obtain prescription refills. We redesigned the portal with this in mind, and usage increased from five percent to 33 percent. Perhaps surprisingly, those with a high school education or some college have the highest usage.”

USING TECHNOLOGY TO PREVENT DIABETES

Dr. Nunlee-Bland is the principal investigator for WEIGHT (Working to Engage Insulin-Resistant Group Health Using Technology), a study evaluating a high-tech program designed to improve nutrition and activity in African American young adults aged 18 to 24 with a diagnosis of pre-diabetes. The goal is to lower body mass index and hemoglobin A1C levels using either state-of-the-art communications and networking technologies or Lifestyle Group Visits.

“We use Fitbits™ integrated with their personal health record. The personal health records are integrated with our electronic health record, so we can see each week how they’re doing,” she explains. “We send positive reinforcement text messages on a weekly basis to encourage them to continue with their diet and exercise. They are also required to complete a 10-

Adam Spector, DPM, doctor of podiatric medicine at Foot and

Ankle Specialists of the Mid-Atlantic, illustrates the importance of having

diabetic patients take off their shoes.


week online healthy lifestyle course. We hope we’ve planted a seed they can carry for life.”

Dr. Nunlee-Bland continues, “Smartphones are ubiquitous; 90 percent of the minority community have one even when they don’t have cable or Internet. We found that people get tired if you text them several times a day, but texting them a motivational message, such as, ‘Have you walked your 10,000 steps today?’ once a week can be effective.”

However, she has found that physician inertia around the use of a patient health portal to communicate with their patients is an issue. “Doctors often see it as another task or burden, not a help. We try to channel communications to nurses, but patients like to have contact with their doctors. Personally, I like this technology. It’s secure, I can see if patients have read my message, it works better for my workflow and I’m not playing phone tag with my patients.”

THE ROLE OF WOUND CARE CENTERS

As the number of specialized wound care centers has risen in the last few decades, diabetics with non- healing wounds have greater access to the multidisciplinary care and advanced treatments needed to tackle the toughest challenges.

David Zachary Martin, MD, chief of Plastic Surgery and medical director of the Wound Healing Center at MedStar Good Samaritan Hospital, explains, “Software tracks our patients’ progress and graphs it out, which is very helpful. The Center has a 96.9 percent heal rate for patients who complete treatment – one of the highest in the country. Some 85 percent of wounds respond to standard care; we try to identify the 15 percent of outliers early on and determine the best modalities for those patients.”

He adds, “Wound care is a partnership between doctors, nurses and patients. All three groups need to be focused on the same goal. When patients first arrive at the Wound Healing Center, many are pessimistic about healing. We help them visualize successful outcomes so they have a distinct goal. We photograph and measure patient wounds at every visit to track progress.”

“The resources we bring to bear today in a wound care center are much greater than in the past,” continues Dr.

Martin. “We provide a huge amount of education to patients. And we keep the medical physician involved to manage the patient’s diabetes.”

USING HBOT

Hyperbaric Oxygen Therapy (HBOT), available as one treatment option among many in wound care centers, has been somewhat controversial, with some studies finding it effective for treating diabetic lower-extremity ulcers, and others questioning its utility.

Dr. Martin notes that misconceptions about HBOT abound. “It’s helpful for distinct wound problems but not a cure-all. Identifying patients early and getting an accurate diagnosis drives the treatment plan. Having established protocols and measuring outcomes – monitoring whether the patient is getting better or worse – is key to success. Our team also works diligently with patients to ensure compliance.”

HBOT should be used in conjunction with other approaches, including debridement in the clinic, offloading pressure on the area, edema control, infection control, management of diabetes and medical comorbidities, and nutrition.

JUDICIOUS USE OF ADVANCED TREATMENTS

A host of newer therapies have been developed to heal wounds, including biological skin equivalents, platelet-derived growth factor and platelet-rich plasma, collagen-based products and intermittent pneumatic compression therapy.

Dr. Martin says, “Today, we have artificial skin derived from both humans and animals that bring growth factors to the wound. Patients with chronic wounds don’t secrete a normal amount of growth factor. Artificial tissues contain growth factors to promote healing. The newer ones are harvested from placentas. They’re effective but very expensive.”

Placental tissues’ anti-inflammatory, antibacterial, low immunogenicity, anti-scarring, and wound protection properties make it ideal for facilitating wound healing.

“Wound care wasn’t a recognized specialty when I graduated from medical school in the early 2000s, but it’s becoming its own discipline,” Dr. Martin notes. “We now

“In my opinion, neglecting to include any one discipline is a high predictor for undesirable outcomes.” – ADAM SPECTOR, DPM


have data that’s driving treatment protocols and we have a much more logical approach to complex wound care. HBOT, artificial tissues and growth factors each have a specific role and we have an obligation to be judicious in their use because they’re expensive.”

EARLY REFERRALS ARE COST EFFECTIVE

“Any new wound that hasn’t healed in three weeks, or any wound in a person with previous wounds that didn’t heal well should be referred to a wound center,” advises Dr. Martin. “The faster we heal the wound, the less expensive the treatment.”

He comments, “Patients can contact the Wound Center directly, and we will determine if a referral from a primary care physician is needed to comply with insurance requirements. ”

PREVENTING LOWER EXTREMITY ULCERS

U.S. diabetics produce an economic burden exceeding $225 billion. Some 15 to 25 percent of these diabetics will develop lower extremity ulcers during their lifetime, making early detection, prevention and treatment a priority.

Adam Spector, DPM, a doctor of podiatric medicine at Foot and Ankle Specialists of the Mid-Atlantic, comments, “Traditional approaches still dominate our treatment strategies: addressing underlying etiologies remains paramount, as uncontrolled blood sugar or vascular disease, for example, negates the benefit of high-tech therapies like hyperbaric oxygen chambers, silver-impregnated wound gels or genetically engineered skin grafts.”

PODIATRISTS PART OF MULTIDISCIPLINARY TEAM

Dr. Spector also underscores the belief that the care of diabetic patients should be multidisciplinary, in which vascular, neurology, endocrine, infectious disease, internal medicine, orthopaedic, and podiatry are cohesively intertwined to facilitate optimal treatment. He observes, “In my opinion, neglecting to include any one discipline is a high predictor for undesirable outcomes.”

Dr. Spector continues, “As a vital member of the wound care team, podiatrists have multiple roles to play; they are usually the first physicians to recognize the significance of the ulcer. Podiatrists surgically debride necrotic tissue or drain infections when necessary – an often neglected, yet fundamental tenet of treatment.

“I make sure my diabetic patients have all the other pieces of the puzzle in place. We can’t achieve long-term success for these complex patients by ourselves.”

AVOIDING AMPUTATIONS

Thankfully, more aggressive, multi-disciplinary wound treatment has significantly slowed the rate of amputations in this population. After reaching a high of 11.3 per 1,000 diabetics in 1996, the rate has steadily declined to 3.3 per 1,000 in 2009, according to the CDC.

Dr. Spector says, “Many well documented studies show that when one foot undergoes an amputation, up to 70 percent of the

time the contralateral foot requires an amputation within five years. The loss of one foot or limb increases the walking pressure on the ‘good foot’ and may decrease patient mobility, contributing to overall poorer health.”

“As foot and ankle surgeons who are also experts in foot biomechanics,” he adds, “we can help prevent recurrence and provide complete care of the underlying structural deformity by offloading the ulcer with total-contact casts, walking rocker-bottom boots, braces and orthotics, and by surgically correcting an ulcer-causing bony deformity when conservative measures are unsuccessful.”

IF THE SHOE FITS

Medicare’s Therapeutic Shoe Bill pays for custom shoes and insoles for diabetics in whom previous amputation, history of ulcers, pre-ulcer callus, foot deformity, or poor peripheral circulation are documented. Dr. Spector states, “This shoe program has been a huge help in preventing ulcers in high-risk patients.”

WEIGH BENEFITS OF SURGERY AGAINST SMALL RISKS

Dr. Spector fears that some physicians needlessly avoid surgery in all diabetics. He explains, “It’s best for physicians to be careful but proactive. For example, a patient with a large bunion on her foot was told that, despite the severe pain and deformity, she should never consider surgical correction because of her diabetes. The bunion, however, limited her activity and put her at risk for a potential ulcer. All surgeries present potential risks, but in a well-controlled diabetic these can be minimized and the long-term benefits can be substantial.”

He adds, “We know that many ulcers that look benign can transform into or masquerade as malignancies. We’ve improved outcomes by performing biopsies in ulcers after a period of slow healing. More studies support this approach, demonstrating increased occurrences of sarcomas and melanomas in ulcers.”

Dr. Spector concludes, “Most wound care can be managed and coordinated out of the office. But for non-healing wounds, we are part of a team at several area wound care centers.” CP

“HBOT, artificial tissues and growth factors each have a specific role and we have an obligation to be judicious in their use because they’re expensive.”– DAVID ZACHARY MARTIN, MD

Gail Nunlee-Bland, MD, FACE, FAAP, chief of Endocrinology and director of the Diabetes Treatment Center at Howard University Hospital, Washington, DCDavid Zachary Martin, MD, a plastic surgeon who is the medical director of the Wound Healing Center at MedStar Good Samaritan Hospital, BaltimoreAdam Spector, DPM, a doctor of podiatric medicine at Foot and Ankle Specialists of the MidAtlantic

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HEALTHCARE IT

DIRECT PRIMARY CARE

.S. healthcare has become prohibitively expensive for a growing number of patients as well as business owners, despite subsidized health premiums

for many under the Affordable Care Act. On top of double-digit premium increases in many health plans for 2016, many consumers are facing annual out-of-pocket expenditures of over $6,000 per person and over $13,000 per family. Often, these costs are front-loaded in the first few months of the year.

Managing the increasingly complex array of health insurance plans has also become a growing headache for physician practices.

In the face of these issues, a growing number of physicians are turning to an

UMichael

Freedman, MD, is one of the

direct primary care pioneers.

The Rise of


DIRECT PRIMARY CAREB Y L I N D A H A R D E R

Tired of fee-for-service medicine but not interested in the concierge model? Today there’s a new option that may embrace the best of outpatient/primary care from both the patient and physician perspective.

alternative called direct primary care (DPC). While the models vary, the basic concept is that most DPC practices charge business owners and/or patients a set monthly fee to provide all or most primary care services, as well as health maintenance and wellness services. Some practices include basic lab work, X-rays, EKGs, and basic procedures such as mole removals as part of this fee. Others have negotiated discounted rates with area providers for certain services, such as imaging. And many also provide health coaches or care coordinators, making them akin to patient centered medical homes (PCMHs).

In return, DPC members get personalized services and typically pay no copays. Their satisfaction rates are reportedly significantly higher given the longer time they can spend with their providers and the better care coordination they receive.

While the model has some similarities to the concierge approach, these DPC practices typically charge far lower monthly rates and are not billing insurers for primary care services. In fact, DPC providers tout that patients can cut their overall healthcare expenses by being able to purchase less expensive catastrophic, or high-deductible wrap-around health insurance.

Florin M. Selaru, MD, MBA, founder of a Columbia, Md.-based DPC model called Clarii Health, states, “We think the direct primary care approach will be truly disruptive to healthcare. If

you’re reducing your monthly premium payments from $900 to $400, you’ve saved $6,000 in the first year alone. The true disruption, however, will likely come from the medium- and long-term population benefits resulting from carefully managing patients between visits to decrease diseases like diabetes or heart disease.”

POPULAR MODEL TARGETS

CONSUMERS, BUSINESSES

DPC is burgeoning. A 2015 article in the Journal of the American Board of Family Medicine by Philip Eskew, DO, JD, MBA, and Kathleen Klink, MD, found evidence of at least 141 DPC practices with 273 locations in 39 states. The American Academy of Family Practice has embraced this model and offers information for physicians seeking to pursue it. 1

DPC practices differ in their target markets, with some targeting major employers and insurers, while others have chiefly targeted individuals. Chesapeake Physician spoke to several local DPC providers to learn more.

B-TO-C APPROACH

Based in Annapolis, Md., Evolve Medical Clinic opened in July 2014. Its owner, internist Michael Freedman, MD, initially considered switching to a concierge model in 2008, but feared that many of his patients would not be able to afford the high monthly fee. When considering concierge medicine again in 2012, he decided to try a DPC model instead.

In the Evolve model, members pay only $35 a month for unlimited primary care contact. Non-members can be seen à la carte for $85 a visit. Evolve also has cut deals with other healthcare providers to allow its members to get significant price breaks on pharmacy costs, imaging, lab work, and other expenses when they pay out of pocket. Dr. Freedman estimates that the average member saves thousands of dollars per year, since they can purchase a lower-cost health plan with far lower monthly premiums, and enjoy reduced testing, referrals and procedures, and also less expensive medications.

Dr. Freedman, who works with a nurse practitioner, estimates that about 1,000 members are needed to break even. He also notes that Evolve meets the definition of a PCMH. “This is the future of primary care,” he exclaims. “Everyone has enough ‘skin in the game’ that they want to help people out. Doctors have incentives to advocate for their patients’ health and their wallets.”

B-TO-B APPROACH

While Dr. Freedman offers a B-to-C approach, other DPC practices chiefly target employers and groups. Qliance, based in Seattle, is one of the largest with a panel of 50,000 patients. Boston-based Iora Health, which has enrolled about 8,000 members and was recently named by Forbes as one of a handful of organizations to ‘turn healthcare upside down in 2016,’ targets employers, health systems, unions, and insurers like Humana’s Medicare Advantage Plan. Paladina Health, based in Denver, is another significant player in the market.

Dr. Selaru launched Clarii Health in mid 2014. While enrolling members directly, its longer-term goal is to attract area businesses and their employees. Located in a business park with 17,000 employees in Columbia, Md., Clarii Health provides primary care along with a health coach,

1 aafp.org/practice-management/payment/dpc.html


nutritionist, behavioral health specialist, and support staff.

Clarii Health charges members $75 per month for unlimited 24/7 contact with its providers and free in-office procedures such as spirometry, EKGs and blood work. They set up an onsite pharmacy that can deliver 90-day supplies of generic medications at wholesale costs. For example, Clarii Health patients can purchase a 90-day supply of a blood pressure medication for $2.50 instead of $155 (the price at large, local pharmacy). Additionally, the practice provides its patients with urgent care, such as treating minor lacerations or removing moles.

Dr. Selaru explains, “There are three pillars to our model of care: 1) access to care 2) between-visit care and 3) wholesale laboratory and medication prices. We contract with business owners in the area and offer them near-site services for their employees. When coupled with an appropriate healthcare policy (and we partner with benefit providers who can help), our model saves business owners up to 30 percent in healthcare costs by being available 24/7 via telephone, messages or in-office visits. Our immediate-care services, wellness services, nutrition, behavioral therapy, and exercise advice are also free for members.”

He adds, “One of our patients in the traditional model recently needed blood work and paid close to $600 because they hadn’t met their high deductible for the year yet. If the blood work had been done in our office, it would have cost about $50 because we have a contract with a reference lab and we pay them instantly and directly. This is our third pillar. We offer hugely discounted laboratory tests, executive-level health and wellness assessments and medications.”

Clarii Health employs a health coach with medical training. Each patient is assigned a health coach and a doctor, and the patient’s friends and family may be recruited to be part of their health team. In the future, they plan to establish a network of specialists, including imaging professionals.

TECHNOLOGY FACILITATES CARE

What most DPC practices have in common besides spending more time with patients is that they take advantage of technology, including telehealth and smartphone apps, to facilitate care. Unlike traditional medical providers, DPC providers don’t have to worry whether or not they’ll be compensated for these services.

Dr. Freedman notes that Evolve offers its own app that contains a link to GoodRx, which helps patients find the least expensive medications. “If you shop around, there are a lot of market forces at work. That’s one place where physicians and their offices can really help patients.”

Dr. Selaru explains that his patients can connect 24/7 via messages, and that Clarii Health offers web-based as well as smartphone-based apps to help patients stay healthy. “We offer continuous care. For example, if someone has hypertension, we can monitor that daily and the dashboard will alert the physician if their blood pressure is out of range that day. We also can pull in a nutritionist to help patients manage their diets, and a cognitive specialist to address any psychological factors that underlie their obesity.

“If a patient has a rash or bruise, they can take a photo and send it to us for remote evaluation,” he continues. “We also use video conferencing to connect to patients. We no longer have an incentive to have you come to the office. We want what our patients want – for them to be happy and healthy.”

BECOMING A DPC PRACTICE

While Dr. Freedman loves practicing under the DPC model, he acknowledges

that getting prospective members to understand how DPC works can be challenging, and that launching the clinic was more complicated than he originally anticipated. He observes, “It’s not an easy concept to explain. Having simple explanations like an animated video on our site are good, but we’ve learned it takes multiple touches to get a patient to sign up.”

To start a DPC, physicians should expect to have to pay up-front legal fees, and should anticipate additional accounting and software complications. Over time, however, a practice may be able to cut overhead by as much as 40 percent through the DPC model.

Practices must determine if they will completely bypass traditional insurance coverage, including Medicare and Medicaid, and whether they want to qualify for the Affordable Care Act exchanges by being bundled with a wrap-around insurance policy.

PHYSICIAN BENEFITS

Dr. Freedman has found other benefits of the DPC model. “I have a stable income that’s not dependent on the number of people I see each day,” he comments. “It’s like a dream come true because I love practicing medicine again.”

He finds that not having to ‘check off the boxes for insurance companies’ makes his practice much more rewarding, noting, “There’s so much beauty outside the walls of insurance.” Dr. Freedman also is convinced that the risk of medical malpractice is much lower with a DPC model.

Dr. Selaru concludes, “Direct primary care is to healthcare what Amazon is to the goods industry. We bring so much value.” CP

“I have a stable income that’s not dependent on the number of people I see each day. It’s like a dream come true because I love practicing medicine again.”– MICHAEL FREEDMAN, MD

Michael Freedman, MD, internist and founder of Evolve Medical Clinic in Annapolis, Md.Florin Selaru, MD, MBA, founder of Clarii Health in Columbia, Md.


COMPLIANCE

Enhancing Your Medical Practice With Telehealth Services and TechnologyBY RANDI KOPF, RN, MS, JD

The use of healthcare technology (often referred to as telemedicine, telehealth, eHealth or eHealthcare)

has provided clinical medicine services and performed remote robotic surgery with the surgeon in the U.S. and their patient on the other side of the world for over 30 years. Yet many physicians are not aware of the healthcare technology that they could add to expand their medical practice. There are many laws, regulations and guidelines that are in place to enable you to use this technology in your practice. eHealth services are often covered services eligible for payment. eHealthcare terms describe the use

of electronic, digital or computerized technology that allows physicians to practice medicine and patients to access care in a new way. You can extend your practice into remote areas, and expand your access to consultations and collaborations with national and international super specialists to enhance your practice of medicine at the office, bedside or your home. Here’s a thumbnail view of the development and use of eHealthcare:

n The military was the first to really utilize telemedicine to provide additional combat zone emergency care to wounded soldiers from physicians in the U.S. via satellite links to laptops at the frontlines of a Middle East conflict. During that military engagement, remote robotic surgery was also developed. Today both technologies have become commonplace for local, nationwide and international medical services.

n What recent developments have propelled the rapid development, proliferation and use of eHealthcare technologies?• Easily affordable personal computers of all sizes and options • The expansion of low-cost accessible Internet services and reliable protected Wi-Fi connections• The rapid development and distribution of multiple hand-held devices, such as

smartphones, iPhone®, iPad®, Fit-Bit®, Tablets, Apple®, and Google’s Android Wear™ watches• The state and federal governments have embraced the use of eHealthcare technology by passing laws to encourage the use and reimbursement of physicians and other healthcare professionals for telehealth services.

OVERVIEW OF THE PLAYING FIELD1

What is eHealth? • eHealth generally refers to the practice of medicine using electronic, computerized or digital technologies, devices or modalities via the Internet, satellites, telecommunications and wellness apps on phones and tablet devices. Please note that some state laws and other entities use the terms Telehealth and Telemedicine interchangeably. However, the terms have different technical definitions and purposes.

What is Telehealth?• Telehealth is a broad term for the use of remote healthcare technology to evaluate, diagnose and monitor patients and electronically prescribe medications (eRx). For example, a bedside screen or hand-held tablet with real-time audio and visual capabilities, enables the physician and patient to see and hear each other during the examination or consultation in real time. This interaction is similar to Skype™ or FaceTime™ functions on tablets and smartphones. For a medical practice to

qualify for telehealth reimbursement, CMS and Maryland law requires real-time interactive audio and visual communication with the patient.2 • The University of Maryland Medical Center 3 is currently using telehealth bedside devices for interactive video and voice communications that allow the physician or nurse to respond to patient calls. They can determine what the patient needs or answer questions in a more personal, time-efficient and effective manner. Some of the other services currently offered include tele-stroke monitoring and diagnosis, high-risk prenatal monitoring, ER to ER communications, doctor to doctor consultations, genetic consulting, school based telemedicine services, psychiatric services, home monitoring for self-management of GI conditions (Crohn’s disease and Colitis), and observation of a patient’s status at home.

What is Telemedicine? • It is the use of telecommunication technology to deliver clinical services such as bedside consults and transmission of digital images (X-rays & scans) or EKGs.

What is Telecare? • It is the use of technology that assists patients to be independent at home or other residence. It transmits data via the Internet or home phone lines. The technology can monitor patients 24/7.• It utilizes devices to monitor, alert, and remind patients of healthcare needs. For example, a reminder when to take a medication.• The technology allows for physician-patient communication, consultation, diagnosis, and identification of medical emergencies. • Current products offer monitoring and data transmission of a patient’s vital signs, pulse, BP, pulse ox and glucose levels, PT time, and EKG data monitoring.4

• The devices are usually hand held with touch screens that send the medical data via Wi-Fi, the Internet, smartphone apps

”Healthcare provided via

technology will be held to the

same standard of care and

duty of care applied to in-

person care and have the same

malpractice legal liabilities.”

– RANDI KOPF


or attachments. For example, glucose levels can be measured and transmitted via smartphone.• One watch-like design has been FDA approved as a Class II device5. It connects via a Bluetooth link to detect when a patient has fallen and it sends an alert for assistance.

What is HIT (Health Information Technologies)?• It is the generation and transmission of digital healthcare data, often via an EHR (electronic health record)• It is used for the sharing of protected health information (PHI) for treatment, administrative activities, research, consultations, evaluations, and practice oversight.

CURRENT LAWS, REGULATIONS AND GUIDELINESn The American Telemedicine Association (ATA) published in May 2015 a state-by-state “report card” comparing and grading each state’s telemedicine polices, limitations, access for patients and the clinical elements of care. In addition, each state is graded on its access and physician encounters using telemedicine.6

n Maryland law and regulations7

• Maryland has promoted the use and practice of telehealth by enacting state laws and regulations that:• Give criteria for reimbursement for services provided• Limit the practice to only licensed Maryland physicians• Establish guidelines for the use of technologyThe goals of legislating the use of telehealth services are to reduce healthcare costs, expand the delivery of health services with patient access and improve patient care overall

n Medicare and Medicaid• Many telehealth services are covered services• Medicare payments are based on the types of services, the professional providing the services, the location of the patient, and technology utilized8 • Medicare Advantage plans9 • Medicaid – Maryland coverage10

n Maryland’s Board of Physicians Regulations for Physicians Practicing Telehealth11

• The physician must be licensed and physically present in Maryland when services are performed

• The patient must be in Maryland when services are received • The interaction must be in “real time” with the patient and physician “face-to-face” • The healthcare interaction must be HIPAA and HITECH compliant• The physician needs to obtain a formal patient informed consent from the patient agreeing to the telehealth services and methods, and give the patient a HIPAA Notice of Privacy Practices (NPP) that includes the methods used to protect the patient’s privacy and PHI when using telehealth • The provider has to have procedures in place to prevent unauthorized access to the transmissions, PHI or data• Healthcare provided via technology will be held to the same standard of care and duty of care applied to in-person care and have the same malpractice legal liabilities. This includes medical record documentation standards

n Who Pays for These Services? • Medicare12 • Medicare Advantage plans13 • Medicaid14 • ACOs• Private-pay managed-care health insurance carriers as per state law15 • Generally Aetna and UnitedHealthcare cover telemedicine services for members younger than 65 years old• Maryland law calls for MCO coverage16

• The ATA published the “State Telemedicine Toolkit” that provides an overview of the current insurance coverage and reimbursement for telehealth services for each state, including Medicare and Medicaid. Maryland, DC and Virginia all have some private insurance coverage

EHEALTHCARE COSTS, RISKS AND BENEFITSn Costs

• Purchasing the hardware and software• Educating your staff in technology use and electronic communication skills• Transforming the practice’s administrative management, physicians and staff duties to meet telehealth practices• Maintenance and repairs for the hardware and software

n Risks • If the system malfunctions or crashes it can result in high repair costs, potential liability from the interference with patient care, billing, documentation, and administrative duties• Financial and legal ramifications as a consequence of cybercrimes, such as medical information theft for criminal use, including the unauthorized use of a physician’s DEA and PIN numbers for billing fraud or buying quantities of medications for sale, HIPAA violations or infringement of other state laws• Inability of the physicians, staff and patients to properly use the technology and devices• Potential for misdiagnosis and malpractice from inadequate or malfunctioning technology or misinterpretation of transmitted data• Potential for HIPAA violations and the unauthorized access by third parties to electronically transmitted or stored communications (hacking) • Other legal liabilities, such as misrepresentation of services offered• Professional licensure liability issues, for example, practicing across state lines without a license in the other state or violations of State Professional Code of Conduct• Patient injury or death associated with technology use, especially for serious medical situations

n Practice Benefits • Improves documentation and organization• Increases patient care involvement and communication• Improves response time to patient needs• Increases office visits for patients that you’ve identified via telehealth tools • Convenient, better and more effective use of physician’s time • Facilitates out-of-area specialist consultations• Enables patients’ independence and may reduce some frequent office callers• Can minimize injury and improve outcome of patient injuries and emergencies• Reduces patient hospital/facility readmissions• Provides billable services for patients

“With eHealth technology, medicine can be practiced at the office,

hospital, healthcare facility, at home or on vacation.“

– RANDI KOPF


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American Telemedicine Association, www.Americantelmed.org, “What is Telemedicine?”, http://www.americantelemed.org/about-telemedicine/what-is-telemedicine, 10.26.15, “TELEMEDICINE AND TELEHEALTH SERVICES”, ATA, Jan. 2013

Medicare’s definition of telehealth services (42 CFR 410.78), COMAR 10.32.05.01-.07, an example of this kind of device is made by Avaya One Touch Video

“Telehealth and Risk Management” presentation to the American Association of Nurse Attorneys, , John J. Kormak, MS, Director of Telehealth, University of Maryland Medical Center, Oct. 2, 2015.

Vital Point Home Monitoring Unit

Aframe’s Mobile Care Monitor

“State Telemedicine Gaps Analysis, Physician Practice Standards & Licensure” LaToya Thomas and Gary Capistrant, ATA, May 2015, http://www.americantelemed.org/policy/state-policy-resource-center#

Code of Maryland Administration Regulations (COMAR) - Telemedicine Services (10.09.49), Approval for Reimbursement for Live Video (10.09.49.03), Eligible sites for Transaction Fees (10.09.49.05), Participants Who are Eligible to Receive Telehealth Services (10.09.49.06), Provider Conditions for Participation (10.09.49.07), Limitations and Requirements for Telehealth Services (10.09.49.11), MCO Coverage for Telemedicine Services (10.09.67.31), Regulations for Online Prescribing (10.32.05.02), Physician must be licensed and located in Maryland and Patient Must be in Maryland (10.32.05.03), Standards Related to Telemedicine ( 10.32.05.03), Physician – Patient Evaluation Requirements (10.32.05.05), Standard of Quality of Care and Telehealth Providers Must Obtain Consent (10.32.05.06), Consent is Required Unless Emergency (10.32.05.06) , Physician Discipline (10.32.05.07), Telehealth Providers Must Inform Patients and Consultants (10.41.06.04)

Maryland Annotated Code Statutes - Cross State Licensing, Where the physician and patient must be located and State license to practice medicine (Maryland Health Occupations Code Section 14-302), Reimbursement to Health Care Providers for Telemedicine (Heath-General 15-105.2), Coverage for services delivered through telemedicine -State

Law Requires Private Payer Coverage (Maryland Insurance Code Section 15-139), Definitions of Telemedicine (Health-General 19-319),

Mental Health Telemedicine Related - MD Department of Health and Mental Hygiene, Maryland Value Options, Provider Alert. Telemental Health. July 12, 2011 p. 2, (Accessed Jul. 2015)

Provider Manual, Billing and Reimbursement - MD Department of Health and Mental Hygiene, Maryland Medicaid 2014 Telemedicine Provider Manual, Sept. 2014

viii Medicare Telehealth Policy and Payment Fact Sheet 2014 http://cchpca.org/sites/default/files/uploader/Changes%20to%20Medicare.pdf , HRSA Medicare Telehealth Payment Eligibility Analyzer (http://datawarehouse.hrsa.gov/telehealthAdvisor/telehealthEligibility.aspx), Telehealth and Medicare, The National Telehealth Policy Resource Center, http://cchpca.org/telehealth-and-medicare

ix Health Management Corporation (www.livehealth.com)

x Provider Manual, Billing and Reimbursement - MD Department of Health and Mental Hygiene, Maryland Medicaid 2014 Telemedicine Provider Manual, Sept. 2014

xi Medicare Telehealth Policy and Payment Fact Sheet 2014 http://cchpca.org/sites/default/files/uploader/Changes%20to%20Medicare.pdf , COMAR 10.32.05.01-.07, HRSA Medicare Telehealth Payment Eligibility Analyzer (http://datawarehouse.hrsa.gov/telehealthAdvisor/telehealthEligibility.aspx), Telehealth and Medicare, The National Telehealth Policy Resource Center, http://cchpca.org/telehealth-and-medicare

xii Health Management Corporation (www.livehealth.com)

xiii Provider Manual, Billing and Reimbursement - MD Department of Health and Mental Hygiene, Maryland Medicaid 2014 Telemedicine Provider Manual, Sept. 2014

xiv Coverage for services delivered through telemedicine -State Law Requires Private Payer Coverage (Maryland Insurance Code Section 15-139), MCO Coverage for Telemedicine Services (COMAR 10.09.67.31)

xv Maryland MCO Coverage for Telemedicine Services (COMAR 10.09.67.31)

who can’t travel to the office due to illness, disability, age, limited financial means, or other situations

IS EHEALTHCARE RIGHT FOR YOUR PRACTICE?When asked about adding technology

to their practices, the first thing that comes to mind for many physicians is the federal oversight and detailed regulations associated with electronic medical records.

But healthcare technology can offer your practice so much more. Most physicians who have incorporated technology into their medical practices have reported that it saved them time, assisted with documentation and billing and helped organize themselves and their staff. The technology improved their patient and office communications, reduced no-

shows, improved patient compliance with medications and treatments, and increased their financial bottom line. With eHealth technology, medicine can be practiced at the office, hospital, healthcare facility, at home or on vacation. eHealthcare is a well-established part of medical practice today and its impact will continue to grow. Time to get on board. CP

Randi Kopf, RN, MS, JD at Kopf Health law, LLC can be reached www.KopfHealthLaw.com.


Maryland’s Newest Medicine

MEDICAL CANNABIS

POLICY

ichael Auerbach, MD, a hematologist-oncologist for 34 years, has prescribed chemotherapy many times

in his career and knows well the treatment’s side effects. He’s also known for years that cannabis can help cancer patients undergoing chemo, and that Marinol, a medicine formulated by extracting the active ingredient THC from cannabis, does not consistently provide relief for patients.

“About 10 years ago I started advising my patients to get pot,” Auerbach says, adding that cannabis is “unrivaled as a stimulant for appetite,” particularly when patients are suffering from ageusia, the inability to taste.

Dr. Auerbach, who specializes in adult anemia management in addition to his oncology practice, is pleased that Maryland has legalized medical cannabis, and has already registered as a recommending physician with the Maryland Medical Cannabis Commission. “There is an issue of common sense here,” he comments. “The side-effect profile of this substance is

extremely good, and cannabis has many other secondary benefits.”

Furthermore, he says, legalization will mean safer means of cannabis ‘delivery.’ “I don’t want my patients

smoking,” he notes. “It irritates the airways.”Delegate Dan Morhaim, MD, an ER physician at the University of Maryland Medical Center, professor at the

Johns Hopkins Bloomberg School of Public Health, and delegate to the Maryland legislature, agrees. “I get questions about smoking cannabis all the time,” he says, adding that nonsmoking methods of delivery, such as those provided by vaporizers, oils or tinctures, work well for patients. He also emphasizes that safer and more effective means of cannabis ingestion, along with more accurate dose management, will improve patients’ experience.

Dr. Morhaim, who has worked for decades to legalize medical cannabis, was instrumental in getting Maryland’s legislation passed in 2013. By the end of 2016, he hopes that cannabis will be available to registered patients.

Healthcare professionals were involved in the formation of the bill, and MedChi (the Maryland State Medical Society) and the Maryland Nurses’ Association supported it. They reviewed the legislation and noted that it promotes

BY ELIZABETH LUNT

PHOTOGRAPHY BY TRACEY BROWN

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responsible, safe and effective use of medical cannabis. Public comments were taken throughout, and, Dr. Morhaim says, were addressed in the resulting legislation.

“We had overwhelming bipartisan support from legislators and from both Democratic and Republican governors,” Dr. Morhaim says, noting that public support was also strong for medical cannabis in the state.

“We stopped polling several years ago, it was so overwhelming,” Dr. Morhaim states. The three bills – one that got the Maryland Medical Cannabis Commission underway, the second that made additions and refinements that would make the program work, and the third that laid out the plan for how the state would take applications for growers, processors and dispensaries – passed by near-unanimous vote in Annapolis.

Dr. Morhaim dispels physicians’ fears of a backlash for registering as a cannabis provider. “As far as I know from other states, no doctor has been punished by a state licensing board or dropped from any hospital as long as they have complied with state law,” he says.

He explains that manufacturers are turning cannabis into a dose-managed product. “We can look at it like any fully regulated, tested, dose-managed medicine.”

When patients come in to discuss cannabis, he says, doctors should document the conversation as they would any discussion of a medicine, including the risks and benefits of the drug.

“Cannabis has never killed anyone,” Dr. Morhaim says. “It is one of the safer medicines. As with any other medicine, sometimes it works, sometimes it doesn’t. It is a tool in the toolbox.”

Dr. Morhaim notes that many doctors currently prescribe narcotics to help patients in pain, despite often-severe side effects. With cannabis, he explains, “We have had people report that their narcotic use drops dramatically and they feel better. Judicious use of cannabis can really help some patients.”

“Some doctors worry patients will start coming in simply looking to ‘get pot,’” Dr. Morhaim says. His response to doctors: Conduct the same evaluation you would do if you suspected a patient was manipulating you to receive any medicine or test.

“Patients ask. That doesn’t mean I prescribe when they ask,” Dr. Morhaim comments. “I document why I would give or not give antibiotics for a sore throat, why I would or would not X-ray a bruised fifth toe.”

He adds, “If you act responsibly there should not be any problem. Medical cannabis should be handled like any other aspect of clinical practice.”

And he emphasized that Maryland’s new law does not require physicians to prescribe cannabis. “No provider is compelled to recommend cannabis if they don’t feel the patient needs it.”

Dr. Morhaim notes that significant information about cannabis is available for doctors who want to educate themselves. “There is no reason why physicians who have access to all the information in the world should have a hard time learning about a medicine that has been around for 10,000 years.”

Gene Ransom, CEO of MedChi, says he has seen a willingness in the medical community to learn about and get on board with the new program. MedChi held an educational seminar last spring and is planning more. He notes that registering with the Commission is an easy process that doctors can do now.

“This is a good time for our members to register and get their ducks in a row for this program,” Ransom comments, advising that doctors check their malpractice insurance and other business-

Delegate Dan Morhaim, MD, has been instrumental in the legalization of medical cannabis in Maryland.

Michael Auerbach, MD, an oncologist who specializes in adult anemia with practice locations in Baltimore, MD and the District of ColumbiaDan Morhaim, MD, Maryland House of Delegates, District 11Gene Ransom, CEO, the Maryland State Medical Society (MedChi)Eric E. Sterling, commission and chair, Policy Committee, the Natalie M. LaPrade Maryland Medical Cannabis Commission

practice issues so that they are ready to go when cannabis becomes available in 2016.

Eric Sterling, an attorney on the Maryland Medical Cannabis Commission, says that physicians can register to recommend cannabis as long as they have a Maryland medical license that is active, unrestricted, and in good standing, and that they are registered to prescribe controlled dangerous substances in Maryland. Doctors may certify a patient who has a condition that is severe, for which other medical treatments have been ineffective, or for which symptoms can reasonably be expected to be relieved by medical use of cannabis.

“Doctors should not fear the law,” Sterling says, pointing out that in 2014 Congress enacted a law barring the U.S. Department of Justice from interfering in the implementation of state medical cannabis laws.

Dr. Morhaim agrees. Further, he asserts that cannabis is a safe medicine and observes that many medicines have been derived from plants.

“Why has this plant been relegated to the sidelines?” he asks rhetorically. “Now is the time.” CP


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