October 2015 | Physician Magazine by Los Angeles County Medical Association

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REPORTING ON THE ECONOMICS OF HEALTHCARE DELIVERY

A PUBLICATION OF PNN www.PhysiciansNewsNetwork.com

mHealth BEST PRACTICES

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FOR DOCTORS & PATIENTS

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OCTOB ER 2015 | TA B LE OF CONT ENT S

Volume 146 Issue 10

6 Los Angeles County Disaster Healthcare Volunteers 8 ICD-10: Key Changes for Primary Care 18 mHealth & Telehealth Top 10

COVER STORY

12 mHEALTH & APPS

In this issue of Physician Magazine, we will help clarify some pressing mHealth issues, starting with the current regulatory framework and mHealth best practices. We’ll also take a look at the promise of using Apple software to help researchers track and study major diseases as well as how this information will ultimately benefit doctors. You’ll find a top 10 list of medical apps you can use in your practice today and the top 10 health apps to prescribe to your patients.

Physician Magazine (ISSN 1533-9254) is published monthly by LACMA Services Inc. (a subsidiary of the Los Angeles County Medical Association) at 801 S. Grand Avenue, Suite 425, Los Angeles, CA 90017. Periodicals Postage Paid at Los Angeles, California, and at additional mailing offices. Volume 143, No. 04 Copyright ©2012 by LACMA Services Inc. All rights reserved. Reproduction in whole or in part without written permission is prohibited. POSTMASTER: Send address changes to Physician Magazine,801 S. Grand Avenue, Suite 425, Los Angeles, CA 90017. Advertising rates and information sent upon request.

O C TO B ER 2015 | W W W. P H Y S I C I A N S N E W S N E T W O R K .C O M 1

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cal Association is a professional association representing physicians from every medical

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specialty and practice setting PRESIDENT

as well as medical students, interns and residents. For more

Christina Correia 213.226.0325 | christinac@lacmanet.org Dari Pebdani 858.231.1231 | dpebdani@gmail.com David H. Aizuss, MD Troy Elander, MD Thomas Horowitz, DO Robert J. Rogers, MD

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Peter Richman, MD Vito Imbasciani, MD William Averill, MD Richard Baker, MD Pedram Salimpour, MD

than 100 years, LACMA has LACMA BOARD OF DIRECTORS

been at the forefront of current medicine, ensuring that its members are represented in the

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ALTERNATE RESIDENT/FELLOW COUNCILOR

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areas of public policy, govern-

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ment relations and community

ETHNIC PHYSICIANS COMMITTEE REP

relations. Through its advocacy

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efforts in both Los Angeles County and with the statewide California Medical Association, your physician leaders and staff strive toward a common goal– that you might spend more time treating your patients and less

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time worrying about the chal-

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CHAIR OF LACMA DELEGATION

David Aizuss, MD Erik Berg, MD Robert Bitonte, MD Stephanie Booth, MD Jack Chou, MD Troy Elander, MD Hilary Fausett, MD Samuel Fink, MD Hector Flores, MD C. Freeman, MD Sidney Gold, MD Jinha Park, MD Stephanie Hall, MD David Hopp, MD Kambiz Kosari, MD Sion Roy, MD Paul Liu, MD Maria Lymberis, MD Philip Hill, MD Nassim Moradi, MD Vamsi Aribindi Ashish Parekh, MD Jerry Abraham, MD Po-Yin Samuel Huang, MD Michael Sanchez, MD Heather Silverman, MD Annie Wang Nhat Tran, MD Fred Ziel, MD

lenges of managing a practice. LACMA’s Board of Directors consists of a group of 30 dedicated physicians who are working hard to uphold your rights and the rights of your patients. They always welcome hearing your comments and concerns. You can contact them by emailing or calling Lisa Le, Director of Governance, at lisa@lacmanet.org or 213-226-0304.

SUBSCRIPTIONS Members of the Los Angeles County Medical Association: Physician Magazine is a benefit of your membership. Additional copies and back issues: $3 each. Nonmember subscriptions: $39 per year. Single copies: $5. To order or renew a subscription, make your check payable to Physician Magazine, 801 S. Grand Avenue, Suite 425, Los Angeles, CA 90017. To inform us of a delivery problem, call 213-683-9900. Acceptance of advertising in Physician Magazine in no way constitutes approval or endorsement by LACMA Services Inc. The Los Angeles County Medical Association reserves the right to reject any advertising. Opinions expressed by authors are their own and not necessarily those of Physician Magazine, LACMA Services Inc. or the Los Angeles County Medical Association. Physician Magazine reserves the right to edit all contributions for clarity and length, as well as to reject any material submitted. PM is not responsible for unsolicited manuscripts.

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Service Mercer’s team of insurance advisors is knowledgeable about the needs of physicians and is available to walk you through the application process. Preferred’s claims examiners are experts in helping members with an employee injury or illness claim. Plus Preferred’s payroll management and flexible payment plans help you manage your premiums in the way that works best for you and your practice’s cash-flow needs.

Safety In addition to mandatory CalOSHA information and videos on workplace safety, Preferred’s team of Risk Advisors are available for consultations when you need them. They also have a strong fraud prevention policy and as a California-based carrier, they know exactly what it takes to do business successfully in this State.

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P RES IDEN T â&#x20AC;&#x2122;S LET T ER | P ET ER RIC H M AN, M D

I A M A N AT I V E C A L I F O R N I A N , born and raised in the San Fernando Valley. Earthquakes are part of the Southern California lifestyle. In school we trained for the inevitable earthquake (and the possible thermonuclear blast from a Soviet bomb) by ducking under our desks with our fingers interlocked behind our necks for protection. We all know of the San Andreas Fault. When a room shakes, we judge the size of the quake and turn on the TV to see the measurements from Caltech. In 1971 the Sylmar quake hit, causing substantial damage. It measured 6.5 on the Richter scale. There were 64 deaths and 2,543 injuries. Olive View Hospital and the San Fernando Valley Veterans Hospital partially collapsed, and Holy Cross Hospital was beyond repair. Olive View and Holy Cross were rebuilt to the updated earthquake standards. The Van Norman Dam adjacent to the 405 Freeway was damaged, and there was consternation for several days that a rupture would occur, killing tens of thousands and flooding the north-mid valley. I was in junior high school and rode my bike the length of Ventura Boulevard to survey the damage the day of the quake. After I had completed my residency residency at Harbor-UCLA, I returned to the San Fernando Valley for employment with Facey Medical Group. My wife and I bought a house in Northridge in 1992. We spent 18 months doing renovations ourselves. Our son was born in January 1993. The Norhtridge earthquake hit in January 1994. It measured 6.9 on the Richter scale. Fifty-seven people lost their lives (many from the collapse of a single apartment building), and 8,700 were injured. There was extensive damage to freeway overpasses in the North Valley, Simi Valley and Santa Monica. Eleven hospitals were severely damaged. As Angelenos, we need to prepare for the Big One. We need to prepare a family emergency plan. We should have an emergency kit, adequate food and water, tents and sleeping bags for temporary shelter, and supplies to sustain the family for more than one week. When New Orleans was devastated by a known approaching hurricane, it took FEMA more than a week to mobilize assistance. New Orleans was a city of nearly 500,000 people. Los Angeles County has 10.6 million people. We as physicians have a special obligation and need to prepare for this as well. There will be thousands of people with injuries seeking medical attention. Hospital patients may be displaced and sent to other facilities where they will need ongoing medical care. The medical community needs to prepare for this. The Los Angeles County Emergency Medical Services Agency has been planning and training for such an event. Volunteer physicians will be needed to provide emergency and urgent services, perhaps outside of their immediate communities. At a time when there will be personal disruptions, business interruptions, perhaps loss of offices, etc., our knowledge and skills will be most needed. Many of us have volunteered our services in foreign countries, this will be aiding our fellow Angelenos.

4 P H Y S I C I A N M A G A Z I N E | O C TO B ER 2015

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LOS ANGELES COUNTY

Disaster Healthcare Volunteers

BY MILLICENT WILSON, MD; SANDRA SHIELDS, LMFT, LPCC, CTS; AND JEE KIM, EDD, MPH

W E K N O W T H AT a major disaster will hit Los Angeles County.

The question is not if, but when. We need your help—when help is needed the most. The events of September 11 and Hurricanes Sandy and Katrina point to the need for organized systems to recruit and mobilize qualified medical professionals. To meet the increased need for healthcare personnel following disasters, Los Angeles County launched VOLUNTEERS NEEDED INCLUDE: the Los Angeles County Disaster • Physicians of all Specialties Healthcare Volunteer (DHV) program - Emergency Medicine in 2007. LA County DHV is a collaborative - Pediatrics effort led by the Los Angeles Coun - Internal Medicine ty Department of Health Services’ - Family Practice Emergency Medical Services Agency - General Surgeons and Department of Public Health. In addition to the Los Angeles - Orthopedic Surgeons County Surge Unit, there are two - Pediatric Surgeons Medical Reserve Corps (MRC) units - Ophthalmologists within the collaborative. They are MRC Los Angeles and Long Beach - ENT Specialists MRC. - Dentists & Oral Surgeons Volunteers are given a choice of - Radiologists joining one of these units when they - Infectious Disease Specialists register. The DHV Surge Unit is the “hospital ready” team for volunteers • All other medical, health and who wish to be assigned primarily to mental health professionals hospitals and clinics to provide direct patient care following disasters. The MRC Units focus on responding to public health emergencies (including dispensing medication at a Medical Point of Dispensing site to provide mass prophylaxis to the population) and promoting preparedness activities. All of the Los Angeles County DHV Units are a part of a federally mandated effort to recruit and register healthcare volunteers in advance of the next disaster.

WE NEED YOUR HELP | Developing and implementing such a volunteer system in a county as large as Los Angeles presents many challenges. For example, in a large-scale anthrax attack, the county would need as many as 43,000 volunteers to support mass medication dispensing efforts and about 4,000 medical volunteers for the surge-capacity staffing at area hospitals. Although the Los Angeles County Medical Asso6 P H Y S I C I A N M A G A Z I N E | O C TO B ER 2015

ciation (LACMA) has thousands of members here in LA County, it would be difficult to mobilize a group that size to respond rapidly without pre-registration. As recent disasters demonstrate, healthcare providers are eager, willing and able to volunteer in an emergency. We need you to meet the extraordinary demands of a large-scale emergency or natural disaster. Hospitals and other healthcare providers will depend on the services that volunteer physicians can provide. The goal of the new and exciting collaborative effort between LA County and LACMA is to: Pre-identify and register local physicians; streamline their identification at disaster sites; and pre-validate their practice and licensure, credentials and training. It is understood that the first duty of physicians is to their own hospitals, clinics and private practice settings. If asked to deploy, each individual physician may accept, decline or ask to be rescheduled. Registering as a LA County Disaster Healthcare Volunteer will not detract in any way from your obligation to your own facility.

to www.lacountydhv.org and select the Unit that you would like to register in. Volunteers who would like to sign up for the LA County Surge Unit can go directly to the LA County Surge Unit website at www. JoinSurgeTeam.org and click on “Sign-up Now.” Create a username and password. Complete the application. Done! You will receive a follow-up e-mail from the DHV registration system. LACMA members who have questions regarding: • LA County Surge Unit: Dr. Millicent Wilson, LA County EMS Agency at (562) 347-1609 or milwilson@dhs.lacounty.gov • MRC Los Angeles: Jee Kim (213) 637-3636 or JeeKim@ph.lacounty.gov • Long Beach MRC: Veronica Ornelas (562) 5704273 or Veronica.Ornelas@longbeach.gov

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IC D- 1 0 | KEY C H AN GES F OR P RIM ARY C ARE

Key Changes for Primary Care BY MARY JEAN SAGE, PRESIDENT, THE SAGE ASSOCIATES; EXPERT CONSULTANT FOR THE COOPERATIVE OF AMERICAN PHYSICIANS, INC.

DIABETES | Diabetes (codes E08 – E13) has greatly expanded in ICD-10CM. Physicians must document whether the diabetes is Type 1, Type 2, drug- or chemical-induced, or due to an underlying condition. They must document the specific underlying condition, the specific drug or toxin, as well as the use of any insulin. ICD-10-CM requires very specific details regarding any complications or manifestation of the diabetes. For example, code E08.341 denotes diabetes mellitus due to underlying condition with severe non-proliferative diabetic retinopathy with macular edema.

T R A N S I T I O N I N G successfully to the

new ICD-10-CM code set will be particularly important for primary care physicians. ICD-10-CM will allow primary care specialists to more accurately depict chronic conditions as well as other commonly reported diagnoses. Physicians will need to be more specific in their documentation than they likely have been in the past. Because there will be a greater number of code choices in ICD-10-CM, physicians should have to choose an unspecified code less often. The greater specificity in diagnostic coding should help improve disease management and reporting overall. Practices should examine their top diagnoses and compare how those codes will change once ICD-10-CM goes into effect — October 1, 2015. Here are some diagnoses to which primary care providers should pay close attention. This is certainly not an all-encompassing list, but is an example of some of the common diagnoses often reported by the PCP. 8 P H Y S I C I A N M A G A Z I N E | O C TO B ER 2015

HYPERTENSION | ICD-10-CM code I10 denotes essential (primary) hypertension. There are separate codes for hypertension involving vessels of the brain (codes I60 – I69) and hypertension involving vessels of the eye (code H35.0). ICD-10-CM also includes codes for hypertensive heart disease with or without heart failure (code I11), and hypertensive chronic kidney disease (code I12). It is important to note that physicians must document the stage of the chronic kidney disease as well. Additionally, there are codes for hypertensive heart and chronic kidney disease (code I13), and secondary hypertension (code I15). ASTHMA | Asthma (code J45) is another diagnosis that was expanded in ICD-10-CM. Physicians must document whether the asthma is:

- Mild intermittent - Mild persistent - Moderate persistent - Severe persistent - Other and unspecified asthma (in ICD-9-CM, it is classified by type) The physician must also specify whether the asthma is uncomplicated, with acute exacerbation, or with status asthmaticus. ICD-10 instructs the physician to identify tobacco exposure as an additional code when reporting asthma. Those choices are: - Exposure to environmental tobacco smoke (Z77.22) - Exposure to tobacco smoke in the perinatal period (P96.81) - History of tobacco use (Z87.31) - Occupational exposure to environmental tobacco smoke (Z57.31) - Tobacco dependence (F17.-) - Tobacco use (Z72.0)

HEADACHE | ICD-10-CM includes a variety of new codes for report-

ing headaches. For example, when a patient presents with a migraine (code G43), physicians must specify whether it’s common, hemiplegic, persistent, chronic, ophthalmologic, abdominal or menstrual. Cluster headaches and other trigeminal autonomic cephalalgias (code G44.0) are grouped into episodic, chronic, episodic paroxysmal hemicranias, chronic paroxysmal hemicranias, and short-lasting unilateral neuralgiform headache with conjunctival injection and tearing. There are also codes for vascular headaches (G44.1), tension-type headaches (G44.2), post-traumatic headaches (G44.3), drug-induced headaches (G44.4), as well as a variety of other headache syndromes. Many of the codes in the

- With or without aura - Intractable vs. not intractable - With or without status migrainosus

EAR INFECTIONS | ICD-10-CM includes various codes

to denote specific forms of a middle ear infection. These codes are grouped in H65-H67 and distinguish between these forms of otitis media: - Serous - Allergic - Mucoid -Nonsuppurative - Suppurative - Tu b o t y m p a n i c suppurative - Atticoantral suppurative Physicians must also document the following for many of the codes in this section: - Acute vs. chronic - Laterality (left vs. right vs. bilateral) - Any associated perforated tympanic membrane Tobacco exposure should be identified as a second diagnosis, using an additional code when an ear infection is reported.

DEPRESSION | According to the Centers for Disease Control and Prevention, an estimated one in 10 adults reports depression. Depression codes have been greatly expanded in ICD-10-CM. When a patient presents with major depression (codes F32 – F33), physicians must consider and document the following:

sexual behavior). This chapter also includes codes for preventive care, such as Z01.3 (encounter for examination of blood pressure), Z01.4 (encounter for gynecological exam), and more. Many of the codes for reporting well-visits require a selection between “with abnormal findings” or “without abnormal findings.” When abnormal findings are present, a second code is required to identify the abnormal findings. Converting to ICD-10-CM may be a challenging transition for many practices. However, it’s likely that physicians will recognize its benefits over time. ICD10-CM is certainly more complex than its predecessor, but in this changing world of healthcare economics, its increased specificity should prove beneficial to you and your practice. Mary Jean Sage is president and founder of The Sage Associates and expert consultant in billing and coding for the Cooperative of American Physicians, Inc. (CAP). CAP offers a range of products and services, including medical professional liability protection and risk management services, in the healthcare field. The Sage Associates is a leading multispecialty provider of healthcare management services. www.CAPphysicians.com.

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- Single episode vs. recurrent - Mild, moderate, or severe - With or without psychotic features - In partial or full remission

OTHER CODES | Chapter 21 of ICD-10-CM includes an array of codes related to factors that influence health status and contact with health services. For example, primary care physicians may be interested in codes Z55 – Z65, which pertain to health hazards related to socioeconomic and psychosocial circumstances. Codes in the Z68 category denote specific data related to body mass index (BMI). These should be reported additionally when reporting obesity (Code E66) and the BMI is known. Codes in the Z72 category denote problems related to lifestyle (e.g., tobacco use, lack of exercise, and high-risk

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KEY C H ANGES F OR P RIM ARY C ARE | IC D- 1 0

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mHealth BEST PRACTICES

TOP

Apps

FOR DOCTORS & PATIENTS

mHEALTH | is an abbreviation for mobile health, a term used for the practice of medicine and public health supported by mobile devices. mHealth applications include the use of mobile devices in collecting community and clinical health data, delivery of healthcare information to practitioners, researchers, and patients, real-time monitoring of patient vital signs, and direct provision of care via mobile telemedicine.

BY MARION WEBB

With more and more Americans expressing interest in monitoring their health using mobile devices, and with doctors’ acceptance and usage of these technologies on the rise, the way to incorporate them into physician practices raises many questions and concerns. In this issue of Physician Magazine, we will help clarify some of these issues, starting with the current regulatory framework and mHealth best practices. We’ll also take a look at the promise of using Apple software to help researchers track and study major diseases as well as how this information will ultimately benefit doctors. You’ll find a top 10 list of medical apps you can use in your practice today and the top 10 health apps to prescribe to your patients.

Regulatory Framework | There is no denying that the world of mobile health, or mHealth, is continually changing, due in large part to rapid advances made by the innovative industry. This, in turn, has brought challenges to regulating the industry in terms of ensuring proper consumer access and patient safety. FDA | Recent moves by the U.S. Food and Drug Administration (FDA) to

provide more transparency regarding compliance with governing laws have been welcome news to the mHealth industry, which requested the transparency. As it stands today, consumer apps such as those that track fitness or provide reminders for doctors’ visits and/or drug dosing schedules or save and display particular medical records are not regulated by the FDA, according to an article written by attorneys at Wiley Rein LLP. The agency also does not regulate mobile apps sold in the Apple iTunes Store or Google Play. Remaining under FDA oversight, as stated in the FDA’s final guidance, are “mobile apps that are medical devices and whose functionality could pose a risk to patient’s safety if the mobile app were to not function as intended.” Apps that clearly fall under FDA oversight and require clearance, the attorneys noted, comprise those that connect to a medical device to control it or are used for active patient monitoring or medical data analysis; transform mobile platforms into regulated devices by using attachments or functionalities similar to those found in regulated devices; or perform patient-specific analysis, diagnosis, or treatment recommendations. The attorneys pointed out that confusion still exists for those inventing apps that include both characteristics of a “medical device” and an app that doesn’t fall under the FDA’s regulatory framework.

FCC | Ambiguity also still exists when it comes to questions pertaining to

privacy protection such as who monitors sensitive health data and where it gets stored, which are issues regulated by the Federal Communications Commission (FCC). The FCC and FDA entered into a Memorandum of Understanding to collaborate with each other within the areas of their respective agencies. The attorneys further noted that the FCC’s recent action to change the regulatory classification of broadband to be more highly regulated — in the same manner as safeguarding consumer data by telephone companies — by directing broadband providers to employ “effective privacy protections in line with their privacy policies,” may “unintentionally be muddying the waters.” Although the new rules imposed through broadband reclassification apply only to broadband providers, a petition has already been filed by Consumer Watchdog to apply the new rules to edge providers like Google and Facebook to give the FCC authority to force those companies to honor consumers’ “do not track” preferences, the attorneys wrote. While it remains to be seen what action the FCC will take, the request would extend new privacy rules to all edge providers, including mHealth apps.

FTC | Finally, the Federal Trade Commission (FTC) also collaborates with the

FDA and FCC to protect consumers from unfair and deceptive acts or practices as well as false or misleading claims, the attorneys wrote. When it comes to mHealth, they said, the FTC has already been active in enforcing against mobile health app marketers that have not met those requirements.

of 2,024 Americans by Research Now, 56% of Americans want their doctors to monitor their health using connected health devices and both consumers and doctors believe that mobile health apps are beneficial to quality of life. Of 1,000 mobile health users surveyed, 60% said they use apps to monitor workouts and activity, and 53% use apps to get motivated to exercise. Using apps to monitor calorie intake and weight loss ranked third and fourth. Among

the

500

surveyed

healthcare professionals, the majority, or 86%, believed that using mobile health apps will increase their knowledge of their patients’ medical conditions, and 76% said it will help them manage patients with chronic

diseases.

Sixty-one

percent said they believed they could use apps to help those at high risk for developing health issues, and 55% believed they could use them to help healthy people stay healthy.

mH EALT H & AP P S | F EAT U RE

According to an online study

F EAT U RE | mH EALT H & AP P S

The attorneys noted that while all three agencies seem to have adopted the idea of fostering regulatory flexibility, they also have reserved discretion given that mHealth appears highly innovative and complex.

Best Practices for Physicians | With the technol-

ogy rapidly evolving, it may be difficult to figure out which mobile health solutions are right for you and your practice. Here are some ways that doctors have successfully implemented mobile and portal technologies into their practices as well as what things to consider when doing so, according to Physicians Practice, a practice management website, and other experts.

1. PATIENT PORTALS | Patient portals are a great way to streamline patient visits and help patients come to appointments more informed. A good way to approach this is to send patients a message prior to their visit to fill out paperwork and bring it to the visit.

2. MOBILE APPS | Mobile apps can be a great way

to monitor patients’ health, and more doctors are open to prescribing them. According to Manhattan Research data, the conversation is more likely to take place if a doctor is part of an ACO. Some 90% of doctors who own a wearable device or use health apps themselves had discussions with patients about wearable devices. For the top consumer apps, see the sidebar of this story.

3. TEXT MESSAGES | More doctors also find that text messages are a great, effective and cost-effective way to remind patients of appointments. According to a Cochrane Collaboration review, “Text message reminders improved the rate of attendance at healthcare appointments compared with no reminders . . . and postal reminders.” 4. ACTIVITY TRACKERS | When it comes to tracking activity and health information that can be shared by providers, the question is, do doctors want and need all that information to help them make a better diagnosis or provide better care?

FAST GROWTH EXPECTED IN MEDICAL APPS MARKET | The medical apps market is estimated at $489 millio

huge compared to the total app market, the mhealth apps market was a mere $85 million five year

expected to be a fast growing area and one with loyal customers. The finding was made in Kaloram

“mHealth Markets Worldwide.” The report indicates that estimated ownership trends among hea mHealth sales. Over five years ago, around 25% of practicing physicians in the U.S. used a PDA or

other uses. This increased to approximately 35% to 40% in 2008. By 2010, more than 50% of physici

a regular basis for everyday treatment activity. Today upwards of 70% of physicians and medical wo

regular basis. And when they use apps, they tend to pay more, with medical apps averaging $9. The apps is estimated at 41.9% compounded annually over the past five years, while the growth for all

iOS platform is the highest performing among its competitors with about 55% of the medial app m

Sales for medical apps for Apple smartphones, tablets and similar equipment can be estimated at $

has experienced increasing competition from its main competitor Android (Google) and newer co

platform in recent years. The result has been a slowly eroding market share. However, the growing u tions is keeping Apple at the top of the list.

1 4 P H Y S I C I A N M A G A Z I N E | O C TO B ER 2015

TOP 10 MEDICAL APPS FOR DOCTORS

Apple ResearchKit Software | Among the most

recent technological advances that research scientists are considering in mobile technology is the ResearchKit software introduced by Apple this March with five apps to investigate Parkinson’s disease, asthma, heart disease, diabetes and breast cancer. A sixth app was reportedly released in June to collect information for a long-term study on gays and lesbians by the University of California, San Francisco. This is how it works: Any iPhone user who wants to participate in a study can simply download the app and fill out a questionnaire to determine eligibility and establish a baseline for comparisons. Users learn about the study before giving consent. The idea is that scientists at research institutions can use the preliminary data from participants to gain a better understanding of major diseases. To protect privacy, Apple will not see any data. To date, more than 75,000 people have enrolled in the health studies, which use specialized iPhone apps built with software Apple created to turn the smartphone into a research tool. Once

on in 2015. While that’s not

rs ago. And medical apps are

althcare workers are a driver in smartphone for professional and

ians used smartphones or PDAs on

orkers use mobile medical apps on a

e report indicates growth for medical apps combined is at 38.1%. Apple’s

market in terms of dollars for 2015.

$268.8 million for the year. Apple

ompetition from the Windows

use of the iPad in health func-

UP TO DATE | chock-full of medical info that gives answers to clinical questions when needed. App is free. Subscription is $499 a year per physician. DOXIMITY | social network for doctors. App and membership in the network are free. READ BY QXMD | centralizes medical literature and journals in magazine format. App is free. Some PubMed and other journals require subscription or credentials. NEJM THIS WEEK | access articles, images of medical conditions, listen to video and audio of articles. Free. SKYSCAPE | decision-support tool with drug information, a medical calculator, evidence-based clinical information and summaries of journal articles. ISABEL | database of more than 6,000 disease presentations and symptoms with the ability to refine by age, gender and travel history. App requires online access. Monthly subscription is $10.99, or annually $119.99. MEDSCAPE | a unit of WebMD that offers prescribing and safety information for drugs, procedure videos, a medical calculator and continuing medical education (CME) information. KIDSPEAK | free app geared toward pediatricians, family physicians and emergency medicine physicians; explains disease pathology to parents and kids in an easy-to-understand manner. PROGNOSIS PSYCHIATRY | a collection of case-based presentations on patients with psychiatric complaints.

The following health apps, rated by thousands of physicians in a HealthTap survey based on ease of use, effectiveness, medical accuracy, validity and soundness for patient prescriptions, as well as other physician recommendations, made the top 10 list:

1. Weight Watchers Mobile 2. My Fitness Pal and Run Keeper 3. White Noise Lite 4. Instant Heart Rate and Glucose Buddy 5. Pocket First Aid & CPR (Jive Media) 6. Calorie Counter and Diet Tracker (MyFitnesPal.com) 7. Spot a Stroke Fast by the American Heart Association 8. Drugs.com 9. Health Tap 10. The American Red Cross

REPORT | Smartphone users now have more than 165,000 apps available to help them stay healthy or monitor a medical condition, but just three dozen account for nearly half of all downloads, the IMS Institute for Healthcare Informatics reports.

ma Information’s recent report

EPOCRATES | remains the gold standard for medical apps to look up drug information and interactions, find providers for consults and referrals and quickly calculate measurements such as BMI.

TOP 10 HEALTH APPS FOR CONSUMERS

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THE INTERNET OF THINGS (IoT) | refers to any object or device that connects to the Internet to automatically send and/or receive data, including medical devices, such as wireless heart monitors or insulin dispensers; wearables, such as fitness devices; and office equipment, such as printers. IoT devices connect through computer networks to exchange data with the operator, businesses, manufacturers and other connected devices, mainly without requiring human interaction.

enrolled, iPhone users use the app to submit data on a daily basis by answering survey questions or using the iPhone built-in sensors to measure their symptoms. For instance, the Parkinson’s mPower app uses the iPhone sensors to measure and track patients’ symptoms from tremor, balance and gait, and also asks participants to provide information before and after they take medications every day. The goals are to cull insights into the variables of Parkinson’s, find better ways to track the progression of the disease and improve the quality of life for those living with the disease. Another app, the MyHeart Counts app, collects data about physical activity and cardiac risk factors for Stanford scientists studying the prevention and treatment of heart disease. “There are two major elements to the study,” said Michael McConnell, MD, professor of cardiovascular medicine and principal investigator for the MyHeart Counts study, in a press release. “One

is collecting data as broadly as possible on physical activity, fitness and cardiovascular risk factors, which provides important feedback to the participants and helpful research data for our study. The second is studying ways to help people enhance activity and fitness, and decrease their chance of heart disease.” Dr. McConnell also said that while there has been an explosion in the marketing of wearable devices to record and report information about behaviors, physical activity or sleep patterns to improve health, there is limited scientific data to show they’re effective. Stanford wants to study which types of behavior-modification methods actually succeed. The scientists hope that the results will ultimately also help physicians. “Preventive medicine hasn’t worked by having doctors make to-do lists for their patients, then seeing them every six months later and hoping they did everything on the list,” he said.

FBI Issues Cyber Alert for IoT and Medical Devices As more businesses and homeowners use web-connected devices to enhance company efficiency or lifestyle conveniences, their connection to the Internet also increases the target space for malicious cyber actors. Similar to other computing devices, like computers or smartphones, IoT devices also pose security risks to consumers. The FBI is warning companies and the general public to be aware of IoT vulnerabilities cybercriminals could exploit, and offers some tips on mitigating those cyber threats. The FBI specifically calls out the potential vulnerabilities of IoT devices that can lead to the theft of personal information and intentional tampering with devices to cause harm, according to a Health Data Management article on the subject. In particular, the agency warns that unprotected medical devices used in home healthcare, such as those used to collect and transmit personal monitoring data or time-dispense medicines, are a ripe target for cybercriminals, especially devices capable of long-range connectivity.

THE FBI PROVIDED A LIST OF RECOMMENDATIONS TO BETTER SAFEGUARD IOT DEVICES: • Isolate IoT devices on their own protected networks. • Disable UPnP on routers. • Consider whether IoT devices are ideal for their intended purpose. • Purchase IoT devices from manufacturers with a track record of providing secure devices. • When available, update IoT devices with security patches. • Consumers should be aware of the capabilities of the devices and appliances installed in their homes and businesses. If a device comes with a default password or an open Wi-Fi connection, consumers should change the password and allow it to operate only on a home network with a secured Wi-Fi router. • Use current best practices when connecting IoT devices to wireless networks, and when connecting remotely to an IoT device. • Patients should be informed about the capabilities of any medical devices prescribed for at-home use. If the device is capable of remote operation or transmission of data, it could be a target for a malicious actor. • Ensure all default passwords are changed to strong passwords. Do not use the default password determined by the device manufacturer. Many default passwords can be easily located on the Internet. Do not use common words and simple phrases or passwords containing easily obtainable personal information, such as important dates or names of children or pets. If the device does not allow the capability to change the access password, ensure the device providing wireless Internet service has a strong password and uses strong encryption.

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The mHealth & Telehealth T O P

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BY NATHANIEL M. LACKTMAN | FOLEY & LARDNER LLP | WWW.HEALTHCARELAWTODAY.COM

M H E A LT H A N D T E L E H E A LT H continue to be an innovative alternative to traditional brick-and-

mortar medicine. The number of providers offering telehealth services is rapidly increasing, and states are enacting laws requiring health plans to cover telehealth services and mHealth technology at a brisk pace. Listed below are the key issues that providers of telehealth services should keep in mind as they navigate the changing landscape. 1. INVESTMENT ACTIVITY | mHealth (and its cousin

Telehealth) represents the most rapidly growing sector in the healthcare industry. Excitement about this growth is reflected in the concurrent growth in interest in telehealth technologies in the venture capital market. Telehealth provider group Teladoc held an IPO this year with favorable results. Private equity and venture capital continue to invest in telehealth and digital health innovation, as the number of incubators and accelerators grows. U.S. employers spend approximately $620 billion annually on healthcare benefits, and investors recognize the role that technology plays in reducing costs. According to Rock Health, a start-up incubator, funding for digital healthcare technology companies exceeded $4.1 billion in 2014 (125% year over year growth) with over 295 deals closed and an average deal size of $14.1 million. The first six months of 2015 already yielded over $2.1 billion in funding, with no signs of slowing down. As telehealth and mHealth use increases within the healthcare industry, it will continue to generate interest within the investment community.

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2. CROSS-BORDER LICENSURE | With a virtual health platform, the geographic restrictions of brick and mortar clinical practices begin to lose their meaning. Telehealth providers can seamlessly offer services across state and national borders; but they need to be cognizant of the fact that they are generally subject to the state and/or national laws of the places where their patients are located. Moreover, in the heavily regulated healthcare industry, business models and contractual arrangements that work in one state will not necessarily work in other states. There are specific exceptions and some business strategies and models that have been built on those exceptions, but the majority of “direct to patient” arrangements, for example, will require the physician to be licensed in the state where the patient is located at the time of the consult. 2015 saw notable efforts to streamline and simplify physician licensing across state lines. Perhaps the most important example gaining traction is the Federation of State Medical Boards’ Physician Licensure Compact. Under the Compact, participating state medical boards would retain their licensing

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and disciplinary authority, but would agree to share information and processes essential to the licensing and regulation of physicians who practice across state borders. The Compact would function like the Nurse Licensure Compact currently in operation in approximately 24 states. The Physician Licensure Compact has received significant support, and at least 10 states have completed the process necessary to bring it to adoption once it becomes effective.

To manage risk, the provider is best served by practicing the “new” oldfashioned way: increased communication with patients, meaningful information exchange, periodic monitoring, and fostering a strong “doctor/ provider-patient relationship.”

3. EXPANSION OF TELEHEALTH COMMERCIAL INSURANCE COVERAGE | Nationwide, states have begun

to enact laws requiring commercial health plans to cover medical services provided via telehealth to the same extent they cover medical services provided inperson. These laws are intended to promote innovation and care delivery in the private sector by encouraging healthcare providers and plans to invest in and use the powerful telehealth technologies available in the marketplace. Currently, 29 states plus the District of Columbia have enacted commercial payment statutes, and similar bills are in development (or process) in several states. Many hospitals and healthcare providers already offer telehealth services, and patients have been able to access virtual care as part of these healthcare delivery models. But these laws are expected to drive the commercial insurance market to expand telehealth coverage, allowing telehealth to be enjoyed by more patients across the country. Successes in these 29 states will signal the promise of telehealth coverage and payment parity as the remaining 21 states consider their own legislation.

4. NEW PAYMENT APPROACHES | mHealth and tele-

health technologies are particularly suited to alternative payment methodologies because they allow providers to better manage risk. Under a traditional fee-for-service (FFS) payment model, the payor bears almost all of the risk because providers get paid each time they perform a service. A provider has little incentive to manage the patient’s health and the associ-

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ated costs of care. Indeed, compensating a provider on a FFS basis incentivizes the provider to perform more services for more patients, as that is the only way for the provider to generate more revenue. Under capitated, shared savings, or hybrid alternative payment models, the risk associated with overused and high cost services is borne by the provider, who is responsible for managing the health of his/ her/its patient population (hence the trending term “population health management”). To manage risk, the provider is best served by practicing the “new” old-fashioned way: increased communication with patients, meaningful information exchange, periodic monitoring, and fostering a strong “doctor/providerpatient relationship.” Telehealth is a powerful tool to accomplish this because it reduces barriers to accessing care, increases the convenience and likelihood a patient will communicate with the doctor, offers inexpensive remote patient monitoring tools to give the provider a stream of health information, draws on data mining, brings the doctor to the patient, and leverages specialist physician expertise. The increased patient “touches” plus meaningful health information exchange allow providers to better assess and treat patients’ health on a long-term horizon. These are just a few ways telehealth technology allows providers to manage risk far better than traditional bricks and mortar practices. In that sense, telehealth is the innovation of blending high-tech tools with “old-fashioned” doctorpatient relationships.

5 CHRONIC CARE MANAGEMENT | Effective January

1, 2015, telehealth-based Chronic Care Management (CCM) is a new service covered by Medicare. It is perfectly suited for telehealth, as CCM may be provided via remote care services. CCM is another way providers can harness telehealth technology to leverage staffing, improve patient care, increase doctorpatient contact, decrease inpatient length of stay, and ultimately reduce overall patient costs. The CCM billing code (CPT 99490) pays providers on a monthly capitated (per patient per month) basis. Hospitals and

6. INTERNATIONAL TELEMEDICINE ARRANGEMENTS | U.S. com-

panies continue to look abroad for mHealth and telehealth opportunities, particularly in China. They are exploring both institutional arrangements and direct-to-patient service offerings such as Internet-based medical consultations and online second opinions. China is anxious to promote and grow telemedicine, but U.S. companies must be sensitive to the differences on how government authorities in China define and regulate these offerings. The opportunities for growth in telemedicine services in China’s healthcare system are evident. U.S. businesses undertaking projects or contemplating Internet-based healthcare-sector opportunities in China should take steps to assess the legality and compliance issues associated with these projects. Taking steps now to develop proper international arrangements can position providers to best harness these growth opportunities.

7. MEDICARE ACCESS AND CHIP REAUTHORIZATION ACT | Telehealth was one of the beneficiaries of changes introduced by the

so-called “doc fix” bill, formally titled the Medicare Access and CHIP Reauthorization Act (H.R. 2). The legislation was passed by Congress on April 15, 2015, and signed into law on April 16, 2015. It introduced sweeping changes to the reimbursement methodologies and financing of healthcare in the United States, including a notable shift away from the traditional fee-for-service model, a shift towards Accountable Care Organizations and risk-based payment, and a focus on quality and population health. In the Act, telehealth and remote patient monitoring are expressly recognized as, and included in the definition of, “Clinical Practice Improvement Activities” along with care coordination, population health management, and monitoring of health conditions. Moreover, new “Alternative Payment Models” may include payment for telehealth services, even if the services are not otherwise covered by the traditional Medicare program. The Act requires the Government Accountability Office to conduct a study on telehealth and the Medicare program, and a second study on remote patient monitoring and the Medicare program, publishing both reports no later than April 2017.

8. TELEHEALTH APPS AND HIPAA | With the 2014 and 2015 changes

in FDA’s guidance on mHealth apps and medical devices, many telehealth app developers appear to be focusing their “regulatory” attention primarily on whether (or not) their app is a “medical device.” Less attention appears to be focused on the applicability to their

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physicians using telehealth to develop patient population health and care coordination services are taking a serious look at CCM billing, as are third party companies experienced in chronic care services and now looking to offer contracted CCM services on a telehealth platform.

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An independent contractor model also offers flexibility and scalability when the company wants to begin providing services in new states with initially lower patient encounter volumes.

products of privacy and security rules, which are not limited to the rules promulgated pursuant to the Health Insurance Portability and Accountability Act (HIPAA). In reality, an app developer frequently is not a Covered Entity subject to HIPAA rules, and in many apps, the developer is not a Business Associate either. The specifics depend on the nature and function of the app itself. But simply because an app collects identifiable, health-related data, it does not mean that the app is subject to HIPAA. Similarly, a wearable health app used by a consumer is not necessarily subject to HIPAA, nor is a medication-adherence app for patient selfuse. But that does not end the story, and addressing privacy and security issues should definitely be on the “to do” list of any telehealth app developer’s business plan. For example, these apps may be subject to Federal Trade Commission oversight and its “unfair acts” power. In addition, state law may apply, particularly if the developer intends the app to be used in multiple states across the country. Many states have enacted their own state law privacy and security statutes, and they frequently apply to a much broader scope of activities than HIPAA. An app developer can easily be subject to state privacy and security laws, even if it is not a Covered Entity or Business Associate and not subject to HIPAA rules.

9. PHYSICIAN EMPLOYMENT MODELS AND THE UBERIZATION OF HEALTHCARE SERVICES | Many telehealth

companies, particularly those with multi-state footprints, have embraced the uber concept of an on-demand service economy. Some utilize an independent contractor model to develop one or more networks of physician providers, and thereby ensure that the company has access to the services of licensed physicians in each of the states in which the company plans to offer services. An independent contractor model (using 1099 contractors) can help keep overhead costs relatively low because contractor status helps the company avoid taking on some of the financial and reporting obligations of a “W-2/employment model” enterprise.

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An independent contractor model also offers flexibility and scalability when the company wants to begin providing services in new states with initially lower patient encounter volumes. The June 2015 OIG Fraud Alert on Physician Compensation Arrangements served as a reminder that physician contracts must comply with fraud and abuse laws, and that independent contractor arrangements do not enjoy the same flexibility as bona fide employment arrangements under the Employment Safe Harbor to the Anti-Kickback Statute. But another question that has begun to arise for companies using an independent contractor, on-demand service model is whether regulators will start to claim that those contractors are really employees. Teladoc’s S-1 filing issued in connection with its IPO describes how the telemedicine company uses an independent contractor model with its healthcare providers. Teladoc asserted the arrangement is a valid independent contractor relationship, but noted as a risk area that “tax or other regulatory authorities may in the future challenge our characterization of these relationships.” Telehealth companies can look to IRS Revenue Ruling 87-41, 1987-1 CB 296, where the IRS enumerates 20 factors used to determine whether a worker is properly characterized as an independent contractor or an employee. These factors provide a general framework for examining both types of relationships. If a regulator or court were to determine that a company’s independent contractors were actually employees, the costs to the company would be significant. The company would be required to withhold income taxes, to withhold and pay Social Security, Medicare and similar taxes, and pay unemployment and other related payroll taxes (to say nothing of unpaid past taxes and penalties). Companies should take the time to carefully craft their independent contractor agreements under the IRS guidance, particularly if they plan to roll out contracts on a widespread basis for an on-demand telehealth model.

10. REMOTE PRESCRIBING | While virtual consults,

Once the prescribing practitioner has conducted an inperson exam, the regulations do not set an expiration period or a minimum requirement for subsequent annual re-examinations. Several states expressly permit remote prescribing of controlled substances, but the federal Act preempts state law. The Act contains certain exceptions for telemedicine practice, but none of the exceptions (drafted in 2008 before telehealthâ&#x20AC;&#x2122;s recent rapid evolution and refinement) cover the direct-to-patient virtual care model widely used in telemedicine, most notably telepsychiatry, where medical management of mental health is accepted and utilized. The Act includes a process for a telemedicine special registration that, despite being enacted seven years ago, the DEA has not made available for prescribers. Change may be afoot, as congressional committees have instructed the DEA to open this special registration process and make it available to telehealth prescribers. In spring 2015, the DEA announced it will issue a proposed rule to enable a telemedicine special registration. This is a key development for telemedicine prescribers to monitor in 2015. Note, though, telemedicine prescribers should continue to also be mindful of prescribing requirements under applicable state laws.

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diagnoses, and treatment recommendations are gaining widespread acceptance, remote prescribing remains an area of concern for state medical boards, and a number of states require an in-person examination of the patient prior to issuing a prescription. When it comes to DEA controlled substances, however, the issue is becoming red hot as 2015 saw one of the first instances of a DEA action against a physician (located in Dallas) for remote prescribing in an otherwise clinically-acceptable telepsychiatry arrangement. At the same time, the Fifth Circuit Court of Appeals is examining the Fourth Amendment implications and appropriateness of the DEAâ&#x20AC;&#x2122;s use of administrative subpoenas of medical records as a means to investigate physicians for criminal prescribing violations, despite never obtaining a search warrant. A DEA victory in that case might allow it to use administrative subpoenas to examine the medical records of telemedicine prescribers to determine whether or not the prescriber complied with the federal Ryan Haight Act. Federally, remote prescribing of controlled substances is governed by the Ryan Haight Act. The Act and its implementing regulations require a physician to conduct at least one in-person medical evaluation of the patient before prescribing any controlled substances remotely.

AS S OC IAT ION H AP P ENINGS | LAC M A NEWS

CEO’s LETTER

W I T H A S L A T E O F E L E C T I O N S on the ballot this fall, LACMA is encouraging its members to also take a closer look at some of California’s local healthcare issues running hot this season. For one, the California Department of Public Health Office of Health Equity recently released its five-year strategic plan to heal health disparities called The Portrait of Promise: The California Statewide Plan to Promote Health and Mental Health Equity. This plan seeks to provide equal opportunities for mental health and well-being. The plan calls for better data collection and analysis to identify and respond to inequities, strategic communication to build awareness and enlist support to fight against inequities, and through infrastructure development, empower residents and their institutions to act effectively. To learn more about the plan, please visit cdph. ca.gov/programs online. This month, the California Medical Association (CMA) House of Delegates will hold its annual meeting to debate and act on resolutions and reports dealing with myriad medical practice, public health and CMA governance issues. The event will take place from 8 a.m. to 5 p.m. on Oct. 16-18 at the Disneyland Hotel, 1150 Magic Way in Anaheim. For physicians who would like to get involved in Physician Health Committees, the three-hour workshop from 9:30 a.m. to 12:30 p.m. on Oct. 31 at the LAC/USC Medical Center, 2051 Marengo St., Los Angeles, is a great way to network and learn from fellow physicians. Another workshop titled “Professionalism Program for Physicians,” presented by CMA’s Institute of Medical Quality, addresses the legal and ethical issues of practicing medicine in California and introduces participants to available resources to address present and future problems. The program will take place from on Nov. 7 and Nov. 8 at the Hilton Garden Inn, 2100 E. Mariposa Ave., El Segundo. Physicians, dentists, physician assistants and dental assistants are invited to attend. Register today. This program encourages interactive learning and is limited to only 12 participants. Finally, if you haven’t registered for LACMA’s biggest event of the year, the Los Angeles Healthcare Awards, it is not too late. LACMA is once again looking forward to recognizing, through its Patient Care Foundation, outstanding individuals and institutions for their unwavering commitment to increasing access to quality healthcare in Los Angeles County through leadership, innovation, education and service. Register today, or if you are unable to attend, please make a donation to the Marshall Morgan Scholarship Fund at lahealthcareawards.org. We are proud to announce that Richard Baker, MD was selected to receive the 2015 Ethnic Physician Leadership Award sponsored by the CMA Foundation during a luncheon held on Sept. 19 at the Riverside Convention Center. Stay tuned, as this promises to be an interesting election season and an equally exciting time of opportunities for LACMA physicians. Regards,

Rocky Delgadillo Chief Executive Officer

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