New York State Psychiatric Association (NYSPA) Fights Cancer

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1 NEWSPAPER OF THE AMERICAN PSYCHIATRIC ASSOCIATION VOLUME 48, NUMBER 7, APRIL 5, 2013 PSYCHIATRIC NEWS The First and Last Word in Psychiatry ISSN NYSPA Is Lead Plaintiff in Suit Against UnitedHealth Can Balcioglu/Shutterstock APA s 2013 annual meeting is being held in San Francisco from May 18 to 22. Register by April 19 and save on fees. One of the meeting s highlights is a special DSM-5 event on Saturday, May 18, from 4 p.m. to 5 p.m. where meeting registrants can purchase DSM-5 before it goes on sale to the public and meet the DSM-5 Task Force chairs. More information about the meeting appears on pages 19 and 20. U.N. Puts So-Called Conversion Therapies In Spotlight as Human Rights Issue The U.N. joins with a religious organization to explore harm caused by therapists claiming to be able to change sexual orientation, as the practice spreads beyond the U.S. BY KEN HAUSMAN A PA and other medical and mental health organizations are on record as opposing efforts to change individuals sexual orientation, stressing their potential for causing psychic damage and the lack of evidence for their efficacy. Now the United Nations (U.N.) has ventured into that emotionladen issue from an international perspective with a panel discussion on these attempts to cure homosexuality through questionable therapies. Among those on the program, titled Selling the Promise of Change: International Health and Policy Consequences of Sexual Orientation Change, was New York psychiatrist Jack Drescher, M.D., who is also president of the Group for the Advancement of Psychiatry. Issues related to gay, lesbian, bisexual, and transgender rights have largely been absent from the U.N. s agenda, and the session came at a time when litigation in two states California and New Jersey is aimed at outlawing so-called conversion therapies when directed at minors. The program s mission was to explore legalities, ethics, and science behind the movement promoting sexual orientation change efforts and its relationship to international human rights. Panel members were chosen to ensure that the discussion of the issue presented medical, political, international, legal, academic, personal, and religious perspectives. The program s organizers the Unitarian Universalist United Nations Office and U.N-affiliated nongovernsee U.N. on page 32 NYSPA is representing members who say they have experienced problems associated with patient access to mental health treatment and with reimbursement for care. BY MARK MORAN T he New York State Psychiatric Association (NYSPA) has joined a class- action lawsuit against UnitedHealth Group and subsidiaries, including United Behavioral Health (UBH), for alleged violations of the federal parity law and the Affordable Care Act. The class action, filed last month in the U.S. District Court, Southern District of New York, was brought on behalf of three beneficiaries. NYSPA joined the suit on behalf of its members and their patients. Seth Stein, J.D., executive director of NYSPA, told Psychiatric News that the district branch has fielded numerous complaints from its members about systematic denial of mental health and substance abuse treatment by United. Over the past year we have tried to work with United to resolve these complaints but have been unsuccessful, Stein said. Enforcement of existing state and federal parity statutes is necessary to ensure that individuals with mental illness have access to appropriate care and treatment. He was echoed by NYSPA President Glenn Martin, M.D. Our state and see Lawsuit on page 14 PERIODICALS: TIME SENSITIVE MATERIALS INSIDE Scully shares views at national forum on improving mental health care. Common genetic markers appear to link five psychiatric disorders.

2 This is one APA Annual Meeting you don t want to miss! The APA Annual Meeting is designed to provide you with the tools and in-depth learning experiences to expand your knowledge and improve your patient care. By attending the 2013 APA Annual Meeting, you will Learn Expand your knowledge base with new advances in the field of psychiatry, best practices, and clinical research Over 400 clinical and scientific sessions in specialty tracks: DSM-5 Addiction Psychiatry Child and Adolescent Psychiatry Forensic Psychiatry Geriatric Psychiatry Psychosomatic Medicine National Institute on Drug Abuse (NIDA) Benefit from world-renowned lecturers, including three Nobel Laureates Discover Learn everything you need to know about the new DSM-5 Register for seven special Master Courses, including DSM-5: What You Need to Know Value Participate in over 400 clinical and scientific sessions; earn CME; explore the exhibit hall; receive discounts on publications, journals, and CME products all in one location Network Expand your peer network and meet new colleagues from around the world New Lower international member registration fees KEYNOTE SPEECH President Bill Clinton Founder of the William J. Clinton Foundation and 42nd President of the United States nday, May 5:30 p.m. 6:30 p.m. GENERAL INFORMATION CME CREDIT SCIENTIFIC PROGRAM NOTE: THIS ACTIVITY HAS BEEN APPROVED FOR AMA PRA Category 1 Credit(s). The overall scientific program provides a broad range of presentations, which include regular courses and master courses, scientific and clinical reports, seminars, symposia, and workshops, plus many other sessions. For further information, please refer to the Tentative Program Schedule on APA s website and review the CME information in the final Program Guide onsite. A more complete program will be printed in the February 15, 2013 issue of Psychiatric News. The APA is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The APA designates this live activity for a maximum of 50 AMA PRA Category 1 Credits. Physicians should claim only the credit commensurate with the extent of their participation in the activity. EDUCATIONAL OBJECTIVES At the conclusion of this meeting, participants will be able to: Review new research findings in the fields of psychiatry and neuroscience and address gaps in knowledge Acquire new knowledge and skills in clinical psychiatry to improve patient care Identify and remove barriers to the transfer of new knowledge for your practice, and provide culturally competent care for diverse populations Assess a variety of treatment choices, including psychotherapeutic and pharmacological options Recognize health service delivery issues, including barriers to care COURSES Offered in four-hour (half-day), six-hour (full-day), and eight-hour (full-day) sessions, courses either review basic concepts in a special subject area or present advanced material on a circumscribed topic. These sessions are in addition to your meeting registration. See Registration and Course Enrollment for more details. SFCVB PHOTO BY LEWIS SOMMER APA ANNUAL MEETING ON DEMAND Annual Meeting on Demand is a digital library of presentations from the 2013 APA Annual Meeting. Can t attend all the sessions at the Meeting? This is the perfect solution to make sure you get the most of your Annual Meeting attendance. With Annual Meeting on Demand you can watch over 300 hours of educational content presented at the Annual Meeting, both during and after the meeting. Features of Annual Meeting on Demand include: Earn CME credit. (You will have two years to complete quizzes to earn CME credit and print CME certificates online.) Online access to content within 24 hours Streaming content for viewing on mobile technology, including most ipad, iphone and Android devices Companion USB drive with access to the Annual Meeting on Demand library for offline viewing (USB will be sent approximately eight (8) weeks after the meeting) Downloadable MP3 files for convenient onthe-go audio to listen on your MP3 player or in your car To purchase the Annual Meeting on Demand, make sure you register for the Gold Registration Package (rates on next page).

3 HIGHLIGHTS GENERAL INFORMATION EXHIBITS Commercial and educational exhibits will Publisher s Book Fair, Career Fair, APA Member court. For your convenience, the Publisher s Book Fair, Career Fair, International Meetings Pavilion, and APA Member Center will be open Saturday, May 18, 9:00 a.m.-4:00 p.m. Educational and commercial exhibit hours are: Sunday, Monday, and Tuesday, May 19-21, 10:00 a.m.-4:00 p.m. daily. SHUTTLE BUS SERVICE aservice will begin on Saturday, May 18, at 7:00 a.m., and will operate daily throughout the meeting commensurate with the scientific program schedule. It will conclude on Wednesday, May 22, at 5:30 p.m. The Moscone Convention Center will serve as the hub for all shuttle bus routes. SPECIAL SERVICES CIf you have a disability and require special materials or services during the meeting, attach a brief statement describing your needs on the registration form. QUESTIONS REGARDING THE ANNUAL MEETING LThe list below will assist you in directing your questions to the appropriate office. You may write to the offices listed below in care (see individual extensions below). For a full list of services and staff responsibilities, go to: Meetings & Conventions Department: Exhibits: x7382 Registration: x7300 Request for Meeting Space: x7375 Office of Scientific Programs Scientific Program: x7808 Courses: x8530 Administrative Services Airline: x7397 Advance Meeting Information Online: registration or call x7300 Department of CME CME Credit: x8661 American Psychiatric Foundation Sponsorships, funding, and product theater funding: x8519 Office of Communications & Public Affairs Press Activities: x8640 Resident/Medical Student Activities: Resident Education: x8635 REGISTRATION AND COURSE ENROLLMENT ANNUAL MEETING REGISTRATION There are two types of registration packages to choose from: Standard Registration package includes admission to over 400 scientific and clinical program sessions (excluding courses), the exhibit hall, and shuttle bus service from official meeting hotels to the Moscone Convention Center. Gold Registration package includes Annual Meeting on Demand with the standard registration. APA MEMBER DISCOUNT RATES 2013 dues must be paid to qualify for the member rate. Contact the APA Membership Office at or with questions regarding your membership status before registering for the meeting. STANDARD REGISTRATION PACKAGE GOLD REGISTRATION PACKAGE Advance Onsite Advance Onsite Jan. 25- Apr. 20- Jan. 25- Apr. 20- Apr. 19 May 22 Apr. 19 May 22 Full Program $415 $455 $814 $854 Members-in-Training $140 $165 $339 $364 Daily $215 $235 $614 $634 Medical Students $0 $0 $199 $199 Honorary Fellows $0 $0 $399 $399 Presenters $275 $300 $674 $699 NONMEMBER RATES Take advantage of member pricing if your membership application and registration form is received by March 15, A membership application must be submitted with your Annual Meeting registration form. STANDARD REGISTRATION PACKAGE GOLD REGISTRATION PACKAGE Advance Onsite Advance Onsite Jan. 25- Apr. 20- Jan. 25- Apr. 20- Apr. 19 May 22 Apr. 19 May 22 Full Program $1,000 $1,100 $1,399 $1,499 Advocacy Group or Mental Health Chaplains* $160 $170 $359 $369 Residents, Fellows, or Students* $160 $170 $359 $369 Daily $535 $570 $934 $969 Medical Students* $0 $0 $199 $199 Presenters (M.D.) $660 $725 $1,059 $1,124 Spouse/Significant Other $230 $255 $629 $654 * Verification required **Spouse or significant other live in the same household, is not an APA member, and receives mail at the same address. This cannot be used for a colleague, APA member, siblings, or children. Only one additional registration is allowed per full program registrant. Identification will be checked onsite. Registered spouse/significant other attendees can attend all sessions (except Member Only), visit the exhibit hall, and use shuttle bus transportation. NOTE: Complimentary registrations are honored for Course Directors/ Faculty and District Branch Executive Staff (who are not APA members). SFCVB APA 166 TH ANNUAL MEETING

4 REGISTRATION AND COURSE ENROLLMENT COURSE/MASTER COURSE ENROLLMENT FEES Courses are designed to emphasize learning experiences that actively involve participants and include the opportunity for informal exchange with the faculty. Attendees must be registered for the annual meeting and purchase tickets to attend courses. For a complete list of Courses/Master Courses offered at the 2013 APA Annual Meeting, please visit the Course Brochure at Advance Onsite Jan. 25, 2013 Apr. 20, Apr. 19, 2013 May 22, 2013 Half Day $165 $190 Full Day (6 hours) $240 $275 Full Day (8 hours) $300 $340 Master Courses (6 hours) $350 $380 3 EASY WAYS TO REGISTER Online: Visit Fax: Complete the registration form on the next page and fax to Mail: Complete the registration form on the next page and mail form and payment to: Ame rican Psychiatric Association Annual Meeting P.O. Box Boston, MA NOTE: Mailed and faxed registrations are assessed an additional $10 and will not be accepted after April 19, Register online and save! The APA shares some personal identifying information about the Annual Meeting registrants with meeting exhibitors. This includes your name, title, mailing address, and address. PAYMENT The APA only accepts VISA, MasterCard, American Express, money order, or a check (in U.S. funds only), payable to the American Psychiatric Association. APA does not accept bank or wire transfers. Registrations will not be processed without proper payment. CONFIRMATION If you do not receive registration and/or course enrollment confirmation within three weeks of sending your form, contact the APA office at or registration@psych.org. PROVISIONAL REGISTRATIONS Nonmember medical student, non-medical student, advocacy group member, mental health chaplain, psychiatric resident and fellow registrations are considered provisional until status verification is received. To qualify for the fee reduction or exemption, a copy of your valid student ID or letter from advocate/chaplain institution or residency program director must be received within seven (7) days of your online registration or included with your mailed or faxed registration. If your verification is not received within this time period, the registration will be cancelled. CANCELLATION FEES & REFUNDS All registration and/or course cancellation requests must be received in writing by the APA Office fax: or registration@psych.org by May 8, A confirmation will be sent once the request has been processed. The fee will be refunded in the manner in which it was received. Refund policy and cancellation fees are as follows: Until March 15, 2013 March 16 May 8, 2013 After May 8, 2013 Full refund Refund less the cancellation fee equal to 25% of total amount paid No refunds ONSITE REGISTRATION HOURS Onsite registration will take place at the Moscone Convention Center. Friday, May 17, 2013 From 11:00 a.m. 12 noon exclusive members only registration 12 noon 6:00 p.m. Saturday, May 18, 2013 Tuesday, May 21, :30 a.m. 5:00 p.m. Wednesday, May 22, :30 a.m. 10:30 a.m. INTERNATIONAL TRAVEL INFORMATION VISA WAIVER PROGRAM Begin the visa application process immediately. The visa process takes longer than you may anticipate. For International travelers who are seeking to travel to the United States under the Visa Waiver Program (VWP) are subject to enhanced security requirements. All eligible travelers who wish to travel under the Visa Waiver Program must apply for authorization through the Electronic System for Travel Authorization (ESTA). nationals of certain countries to travel to the United States for tourism or business for stays of 90 days or less without obtaining a visa. Invitation Letters from the American Psychiatric Association To receive an invitation letter from the APA (for registered attendees only), write the APA Registration Office at registration@psych.org and include your full name, complete mailing address and Annual Meeting registration badge number. Invitation letters will be sent via in the PDF format. Please allow 10 business days for receipt of your invitation letter. Additional information regarding the VWP and ESTA is available at Also refer to the State Department website at: for more information on international travel, passports and visas. SFCVB PHOTO BY PHIL COBLENTZ APA 166 TH ANNUAL MEETING

5 HIGHLIGHTS REGISTRATION FORM 166th Annual Meeting ADVANCE REGISTRATION: January 25 April 19, 2013 REGISTER ONLINE: Register by fax at or mail your registration form with payment (payable to APA) to: Mailed and faxed forms will not be accepted after April 19, Written cancellations must be received in the APA office by May 8, REGISTRATION INFORMATION (address may be published) First Name APA Member # Last Name Degree Address Address City State/Prov Zip Code - Country (if outside U.S.) * *MANDATORY FOR CONFIRMATION AND FOR MEETING ANNOUNCEMENTS Day Phone Cell Number FOR MEETING ALERTS NPI Number First time attendee? Yes No SPOUSE/SIGNIFICANT OTHER (if registering) First Name Last Name Degree What Is Your Discipline? (Check all that apply) Are you? (Check all that apply) What Is Your Primary Work Setting? (Check all that apply) Psychiatrist Early Career Psychiatrist Private Group International Medical Graduate Private Solo Other MD/DO Resident Year of graduation from residency Academic Faculty Medical Student VA/Federal Facility Other Academic Student COURSE ENROLLMENT Indicate course number found in the Course Brochure. Registrant Spouse/Significant Other Saturday First Choice(s) Alternate(s) Saturday First Choice(s) Alternate(s) Sunday First Choice(s) Alternate(s) Sunday First Choice(s) Alternate(s) Monday First Choice(s) Alternate(s) Monday First Choice(s) Alternate(s) Tuesday First Choice(s) Alternate(s) Tuesday First Choice(s) Alternate(s) Wednesday First Choice(s) Alternate(s) Wednesday First Choice(s) Alternate(s) PAYMENT INFORMATION FULL REGISTRATION Registrant Registration $ $ Sat Sun Mon Tues Wed Registrant Courses $ Spouse/Significant Other Registration $ $ Sat Sun Mon Tues Wed Spouse/Significant Other Courses $ Course Director $ $ 0 Medical Student $ 0. $ Mail/Fax Fee $10 TOTAL PAYMENT $ DAILY I authorize charge of total payment: SIGNATURE Exp. Date CREDIT CARD NUMBER (American Express, MasterCard, or VISA only) TRAVEL INFORMATION Identify yourself as an APA Meeting Attendee For the American Psychiatric Association s 2013 Annual Meeting in San Francisco unique travel discounts are being offered on United, Delta, and American, as well as a variety of low-cost airline carriers, and web fares by MACNAIR TRAVEL MANAGEMENT/ AMERICAN EXPRESS, APA s official travel company. Contact MacNair via the communication channels listed below and secure the best value for your travel to and from the meeting, as well as any pre- or post- meeting travel arrangements you may require. Following are details of the United, Delta, and American discounted fare programs. United To be announced Delta 5-10% off certain published fares on Delta, KLM or Air France American 5% off Call MacNair Travel Management to make your travel arrangements: Toll Free in the U.S. or Canada For residents of Virginia, Maryland, or the District of Columbia, or outside the U.S. or Canada, please call fax your request to (703) requests may be sent to apa@macnairtravel.com APA 166 TH ANNUAL MEETING Or you may contact the following carriers directly: United Airlines Meeting Code: To be announced Delta Air Lines Meeting ID Code: NMENK American Airlines Meeting Code: A4953BV

6 HOTEL RESERVATION INFORMATION HOTEL RESERVATION INFORMATION Online: (click on the 2013 Annual Meeting logo, then housing information, then attendee or exhibitor information, and then on housing and travel) Fax: (nine (9) rooms or less) attached housing reservation form to (212) Fax: (ten (10) rooms or more) attached housing reservation form to (212) Mailing Address: Travel Planners, Inc., 381 Park Avenue South, Third Floor, New York, NY By phone: dial (800) (USA, Caribbean, and Canada); internationally, dial (212) Deposit Policy: Reservations will only be accepted with a credit card guarantee or check deposit. Deposit checks and wire transfers must be received within ten (10) days of booking or by March 22, 2013, whichever is earlier. (Reservations will automatically be canceled if checks or wires are not received within this time frame.) After March 22, 2013, reservations will be accepted with a credit card guarantee only. Reservations and changes are subject to hotel availability. Please check your reservation confirmation for details. Cancellation Policy: Cancellations of hotel reservations must be made directly with Travel Planners. Additional Reservation Information: 1. Travel Planners will process requests on a first-come, first-served basis. 2. Group bookings will be based on previous room pick-up history and per APA guidelines for exhibitors. 3. Group rooming lists are due on March 15, On March 16, 2013, any unassigned room held for a group will be released if name is not provided and rooms are not guaranteed with a credit card or check deposit. 4. Reservations will be accepted with a credit card guarantee or check deposit only. a. If you are making more than one reservation, you will need to provide a credit card and billing address for each room to be charged. b. If one card is going to pay for all rooms (up to a maximum of 10 rooms) then only one card and address is necessary. c. A different credit card must be used for every ten (10) rooms. 5. The following credit cards can be used to make your reservation: Visa, MasterCard, or American Express. 6. Each credit card must be valid through the reservation dates of the stay. Should your card expire prior to the 2013 Annual Meeting, you may guarantee your block with a deposit by check. 7. To pay by check, make check payable to: Travel Planners, Inc., and mail to: Travel Planners, Inc., 381 Park Avenue South, Third Floor, New York, NY Suites and function/meeting space are for approved affiliates only and requests must be approved by APA. Affiliate Meeting Space Request Forms are available through the APA website beginning November 15, Individual policies for each hotel must be strictly adhered to. Most hotels impose fees for early departures. This policy is at the discretion of the individual hotel and the amount of the fee varies by hotel. Be sure to verify your actual date of departure at the time of check in. 10. For fax or group reservations (10 rooms or more), you will receive a confirmation within three business days. 11. For fax requests, please provide credit card information upon receipt of confirmation. 12. For individual online reservations, you will receive a confirmation immediately. Travel Planners, Inc. makes no guarantee of any kind that the hotels and rates listed will be available at the time you make your reservation. Reservation requests and changes are subject to the availability and discretion of the hotels. All information is as of September 5, 2012, and subject to change. HOTEL REGISTRATION FORM 166th Annual Meeting Name: Date: Company Name: Address: (Street) (Suite/Floor) (City) (State) (Zip/Country Code) (Country) Contact Name: Phone: ( ) Ext. Fax: ( ) NO ADVANCE DEPOSIT REQUIRED HOTEL SELECTION (Please fill in all six choices) 1 st : 4 th : 2 nd : 5 th : 3 rd : 6 th : Use more than one row for different dates if necessary and indicate the number of rooms required for each room type. Occupant Name (required) Attendee, Exhibitor, or APA Member? Check-In Date Check-Out Date # Single Rooms # Double Rooms (2 ppl/1 bed) # Twin Rooms (2 ppl/2 beds) Total number of rooms needed: SPECIAL REQUIREMENTS/REQUESTS: Do you require an ADA-Compatible Room? Smoking or Nonsmoking? Other requirements/requests? This form is to indicate preference only and submission does not guarantee confirmation. Notification of confirmed details will be faxed/ ed by Travel Planners, Inc. within three business days of receipt. Cancellation policy: policies are strictly adhered to and may vary by hotel. Cancellation policies will be outlined on your confirmation. Travel Planners, Inc. makes no warranties of any kind that the hotels and rates listed will be available at the time you make your reservation. Reservation requests and changes are subject to the availability and discretion of the hotels. APA 166 TH ANNUAL MEETING Fax: (212) (9 rooms or less) (212) (10 rooms or more) Mail: Travel Planners, Inc. 381 Park Avenue South, Third Floor New York, NY If you do not receive confirmation receipt within three business days, please call Travel Planners, Inc. Please Note our Privacy & Security Policies: We take your privacy seriously. Help us to protect your credit card information by using our secure website to enter this information. For your protection, please do not send credit card information to us in any other way. If you are unable to enter your credit card information in the specified credit card area on our website, please call us to provide this information verbally so that we may enter it into our system. 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7 Schizophrenia can tear patients apart For the treatment of schizophrenia LATUDA can help put your patients back together Symptom improvement was established in several pivotal trials 1 The safety and tolerability of LATUDA were evaluated in pivotal trials and multiple studies up to 52 weeks 1 The recommended starting dose, 40 mg/day, is an effective dose with no initial dose titration required. The maximum recommended dose is 160 mg/day 1 LATUDA should be taken with food (at least 350 calories) Dose adjustment is recommended in moderate and severe renal and hepatic impairment patients. The recommended starting dose is 20 mg. The dose in moderate and severe renal impairment patients and in moderate hepatic impairment patients should not exceed 80 mg/day. The dose in severe hepatic impairment patients should not exceed 40 mg/day LATUDA should not be used in combination with strong CYP3A4 inhibitors such as ketoconazole or strong CYP3A4 inducers such as rifampin. When coadministered with a moderate CYP3A4 inhibitor such as diltiazem, the recommended starting dose of LATUDA is 20 mg/day and the maximum recommended dose is 80 mg/day INDICATIONS AND USAGE LATUDA is an atypical antipsychotic indicated for the treatment of patients with schizophrenia. Efficacy was established in five 6-week controlled studies of adult patients with schizophrenia. The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. IMPORTANT SAFETY INFORMATION FOR LATUDA WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. Please see additional Important Safety Information, including, and Brief Summary of Prescribing Information on adjacent pages. LATUDA and are registered trademarks of Dainippon Sumitomo Pharma Co., Ltd. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd Sunovion Pharmaceuticals Inc. All rights reserved. 9/12 LATV367-12

8 INDICATIONS AND USAGE LATUDA is an atypical antipsychotic agent indicated for the treatment of patients with schizophrenia. Efficacy was established in five 6-week controlled studies of adult patients with schizophrenia. The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. IMPORTANT SAFETY INFORMATION FOR LATUDA WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. CONTRAINDICATIONS LATUDA is contraindicated in the following: Any patient with a known hypersensitivity to lurasidone HCl or any components in the formulation. Angioedema has been observed with lurasidone. Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole). Concomitant use with strong CYP3A4 inducers (e.g., rifampin). WARNINGS AND PRECAUTIONS LATUDA is not approved for the treatment of patients with dementia-related psychosis. NMS, a potentially fatal symptom complex, has been reported with administration of antipsychotic drugs, including LATUDA. NMS can cause hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant serious medical problems for which specific treatments are available. The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Given these considerations, LATUDA should be prescribed in a manner that is most likely to minimize the occurrence of TD. If signs and symptoms appear in a patient on LATUDA, drug discontinuation should be considered. Hyperglycemia and Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug. Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended. As with other drugs that antagonize dopamine D2 receptors, LATUDA elevates prolactin levels. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds. Leukopenia/ neutropenia has been reported during treatment with antipsychotic agents. Agranulocytosis (including fatal cases) has been reported with other agents in the class. Patients with a preexisting low white blood cell count (WBC) or a history of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy, and LATUDA should be discontinued at the first sign of a decline in WBC in the absence of other causative factors. LATUDA may cause orthostatic hypotension. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension and in patients with known cardiovascular disease or cerebrovascular disease. LATUDA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold (e.g., Alzheimer s dementia). In short-term, placebo-controlled trials, somnolence was reported in 17.0% (256/1508) of patients treated with LATUDA compared to 7.1% (50/708) of placebo patients, respectively. Patients should be cautioned about operating hazardous machinery, including motor vehicles, until they are reasonably certain that therapy with LATUDA does not affect them adversely. Disruption of the body s ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing LATUDA for patients who will be experiencing conditions that may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration. The possibility of suicide attempt is inherent in psychotic illness and close supervision of high-risk patients should accompany drug therapy. Prescriptions for LATUDA should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose. Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer s dementia. LATUDA and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. ADVERSE REACTIONS Commonly Observed Adverse Reactions: (incidence 5% and at least twice the rate of placebo) in patients treated with LATUDA were somnolence, akathisia, nausea and parkinsonism. Please see brief summary of prescribing information on adjacent pages, including. LATUDA prescribing information. Sunovion Pharmaceuticals Inc. May FOR MORE INFORMATION, PLEASE CALL OR VISIT.

9 Brief Summary (for Full Prescribing Information, see package insert) WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS [see Warnings and Precautions (5.1)]. [see Warnings and Precautions 5.1)]. LATUDA is indicated for the treatment of patients with schizophrenia. The efficacy of LATUDA in schizophrenia was established in five 6-week controlled studies of adult patients with schizophrenia [Clinical Studies (14.1)]. The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see Dosage and Administration (2)]. 4 CONTRAINDICATIONS LATUDA is contraindicated in the following: components in the formulation. Angioedema has been observed with lurasidone [see Adverse Reactions (6.1)]. [see Drug Interactions (7.1)]. [see Drug Interactions (7.1)]. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6- to 1.7- times the risk of death in placebo-treated patients. Over placebo group. Although the causes of death were varied, most of the deaths similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the clear. LATUDA is not approved for the treatment of patients with dementiarelated psychosis [see Boxed Warning]. In placebo-controlled trials with risperidone, aripiprazole, and olanzapine in elderly subjects with dementia, there was a higher incidence of LATUDA is not approved for the treatment of patients with dementia-related psychosis [see also Boxed Warning and Warnings and Precautions (5.1)]. A potentially fatal symptom complex sometimes referred to as Neuroleptic administration of antipsychotic drugs, including LATUDA. signs may include elevated creatinine phosphokinase, myoglobinuria The diagnostic evaluation of patients with this syndrome is complicated. It is important to exclude cases where the clinical presentation includes both important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system pathology. antipsychotic drugs and other drugs not essential to concurrent therapy; of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for NMS. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. If reintroduced, the patient should be carefully monitored, since recurrences of NMS have been reported. Tardive dyskinesia is a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements that can develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Given these considerations, LATUDA should be prescribed in a manner antipsychotic treatment should generally be reserved for patients who suffer treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically. If signs and symptoms of tardive dyskinesia appear in a patient on may require treatment with LATUDA despite the presence of the syndrome. Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile. Hyperglycemia and Diabetes Mellitus hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Because LATUDA was not marketed at the time these studies were performed, it is not known if LATUDA is associated with this increased risk. started on atypical antipsychotics should be monitored regularly for atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of the suspect drug. in Table 1. Placebo n=680 n=71 n=478 n=508 n=283 n=113 Serum Glucose Serum Glucose LATUDA was associated with a mean change in glucose of +1.8 mg/dl at week Dyslipidemia Undesirable alterations in lipids have been observed in patients treated with Placebo n=660 n=71 n=466 n=499 n=268 n=115 Total cholesterol Triglycerides Triglycerides Weight Gain monitoring of weight is recommended. [see Clinical Studies (14.1)], respectively. The Placebo (n=696) (n=71) (n=484) (n=526) (n=291) (n=114) 5.6 Hyperprolactinemia elevates prolactin levels. reduced pituitary gonadotrophin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients. Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds. Long-standing hyperprolactinemia, when associated with hypogonadism, may lead to decreased bone density in both female and male patients [see Adverse Reactions (6)]. In short-term, placebo-controlled studies, the median change from baseline to endpoint in prolactin levels for LATUDA-treated patients was Females Males Placebo placebo-treated patients. The proportion of female patients with prolactin placebo-treated female patients. The proportion of male patients with male patients. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if the prescription of these drugs is considered in a patient with previously detected breast cancer. As is common with compounds which increase prolactin release, an increase in mammary gland neoplasia was observed in a LATUDA carcinogenicity study conducted in rats and mice [see Nonclinical Toxicology (13)]. Neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans, but the available evidence is too limited to be conclusive. Leukopenia/neutropenia has been reported during treatment with reported with other agents in the class. induced leukopenia/neutropenia should have their complete blood count absence of other causative factors. symptoms or signs of infection and treated promptly if such symptoms or until recovery. LATUDA may cause orthostatic hypotension, perhaps due to its α1- adrenergic receptor antagonism. The incidence of orthostatic hypotension and syncope events from short-term, placebo-controlled studies was Assessment of orthostatic hypotension was defined by vital sign changes Orthostatic vital signs should be monitored in patients who are vulnerable 5.9 Seizures As with other antipsychotic drugs, LATUDA should be used cautiously in patients with a history of seizures or with conditions that lower the seizure In short-term, placebo-controlled trials, seizures/convulsions occurred in placebo-treated patients. LATUDA, like other antipsychotics, has the potential to impair judgment, thinking or motor skills. In short-term, placebo-controlled trials, somnolence was reported by In these short-term trials, somnolence included: hypersomnia, hypersomnolence, sedation and somnolence. including motor vehicles, until they are reasonably certain that therapy with LATUDA does not affect them adversely. Disruption of the body s ability to reduce core body temperature has been attributed to antipsychotic agents. Appropriate care is advised when prescribing LATUDA for patients who will be experiencing conditions that

10 may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration [see Patient Counseling Information (17.9)] Suicide The possibility of a suicide attempt is inherent in psychotic illness and close supervision of high-risk patients should accompany drug therapy. Prescriptions for LATUDA should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose. In short-term, placebo-controlled studies in patients with schizophrenia, the incidence of treatment-emergent suicidal ideation was 0.4% (6/1508) for LATUDA-treated patients compared to 0.8% (6/708) on placebo. No suicide attempts or completed suicides were reported in these studies Dysphagia Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer s dementia. LATUDA and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia Use in Patients with Concomitant Illness Clinical experience with LATUDA in patients with certain concomitant illnesses is limited [see Clinical Pharmacology (12.3)]. Patients with Parkinson s Disease or Dementia with Lewy Bodies are reported to have an increased sensitivity to antipsychotic medication. Manifestations of this increased sensitivity include confusion, obtundation, postural instability with frequent falls, extrapyramidal symptoms, and clinical features consistent with the neuroleptic malignant syndrome. LATUDA has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Patients with these diagnoses were excluded from premarketing clinical trials. Because of the risk of orthostatic hypotension with LATUDA, caution should be observed in patients with known cardiovascular disease [see Warnings and Precautions (5.8)]. 6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Use in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1)] Cerebrovascular Adverse Reactions, Including Stroke [see Warnings and Precautions (5.2)] Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.3)] Tardive Dyskinesia [see Warnings and Precautions (5.4)] Hyperglycemia and Diabetes Mellitus [see Warnings and Precautions (5.5)] Hyperprolactinemia [see Warnings and Precautions (5.6)] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.7)] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.8)] Seizures [see Warnings and Precautions (5.9)] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.10)] Body Temperature Regulation [see Warnings and Precautions (5.11)] Suicide [see Warnings and Precautions (5.12)] Dysphagia [see Warnings and Precautions (5.13)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The information below is derived from a clinical study database for LATUDA consisting of 2905 patients with schizophrenia exposed to one or more doses with a total experience of patient-years. Of these patients, 1508 participated in short-term, placebo-controlled schizophrenia studies with doses of 20 mg, 40 mg, 80 mg, 120 mg or 160 mg once daily. A total of 769 LATUDA-treated patients had at least 24 weeks and 371 LATUDAtreated patients had at least 52 weeks of exposure. Adverse events during exposure to study treatment were obtained by general inquiry and voluntarily reported adverse experiences, as well as results from physical examinations, vital signs, ECGs, weights and laboratory investigations. Adverse experiences were recorded by clinical investigators using their own terminology. In order to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology. The following findings are based on the short-term, placebo-controlled premarketing studies for schizophrenia in which LATUDA was administered at daily doses ranging from 20 to 160 mg (n=1508). Commonly Observed Adverse Reactions: The most common adverse reactions (incidence 5% and at least twice the rate of placebo) in patients treated with LATUDA were somnolence, akathisia, nausea and parkinsonism. Adverse Reactions Associated with Discontinuation of Treatment: A total of 9.5% (143/1508) LATUDA-treated patients and 9.3% (66/708) of placebotreated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with LATUDA that were at least 2% and at least twice the placebo rate. Adverse Reactions Occurring at an Incidence of 2% or More in LATUDA- Treated Patients: Adverse reactions associated with the use of LATUDA (incidence of 2% or greater, rounded to the nearest percent and LATUDA incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with schizophrenia) are shown in Table 5. Table 5: Adverse Reactions in 2% or More of LATUDA-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in Short-term Schizophrenia Studies Body System or Organ Class Dictionary-derived Term Gastrointestinal Disorders Percentage of Patients Reporting Reaction Placebo (N=708) All LATUDA (N=1508) Nausea 5 10 Vomiting 6 8 Dyspepsia 5 6 Salivary Hypersecretion <1 2 Body System or Organ Class Dictionary-derived Term Percentage of Patients Reporting Reaction Placebo (N=708) All LATUDA (N=1508) Musculoskeletal and Connective Tissue Disorders Back Pain 2 3 Nervous System Disorders Somnolence* 7 17 Akathisia 3 13 Parkinsonism** 5 10 Dizziness 2 4 Dystonia*** <1 4 Psychiatric Disorders Insomnia 8 10 Agitation 4 5 Anxiety 4 5 Restlessness 1 2 Note: Figures rounded to the nearest integer * Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence ** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor *** Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus Dose-Related Adverse Reactions In pooled data from the short-term, placebo-controlled, fixed-dose studies, there were no dose-related adverse reactions (greater than 5% incidence) in patients treated with LATUDA across the 20 mg/day to 160 mg/day dose range. However, the frequency of akathisia increased with dose up to 120 mg/day (5.6% LATUDA 20 mg, 10.7% LATUDA 40 mg, 12.3% LATUDA 80 mg, 22.0% LATUDA 120 mg); akathisia was reported by 7.4% (9/121) of patients receiving 160 mg/day. Akathisia occurred in 3.0% of subjects receiving placebo. Extrapyramidal Symptoms In the short-term, placebo-controlled schizophrenia studies, for LATUDAtreated patients, the incidence of reported events related to extrapyramidal symptoms (EPS), excluding akathisia and restlessness, was 13.5% versus 5.8% for placebo-treated patients. The incidence of akathisia for LATUDAtreated patients was 12.9% versus 3.0% for placebo-treated patients. Incidence of EPS by dose is provided in Table 7. Table 6: Incidence of EPS Compared to Placebo LATUDA Adverse Event Term Placebo (N=709) (%) 20 mg/day (N=71) (%) 40 mg/day (N=487) (%) 80 mg/day (N=538) (%) 120 mg/day (N=291) (%) 160 mg/day (N=121) (%) All EPS events All EPS events, excluding Akathisia/ Restlessness Akathisia Dystonia* < Parkinsonism** Restlessness Note: Figures rounded to the nearest integer * Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus ** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor In the short-term, placebo-controlled schizophrenia studies, data was objectively collected on the Simpson Angus Rating Scale for extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (for akathisia) and the Abnormal Involuntary Movement Scale (for dyskinesias). The mean change from baseline for LATUDA-treated patients was comparable to placebo-treated patients, with the exception of the Barnes Akathisia Scale global score (LATUDA, 0.1; placebo, 0.0). The percentage of patients who shifted from normal to abnormal was greater in LATUDA-treated patients versus placebo for the BAS (LATUDA, 14.4%; placebo, 7.1%) and the SAS (LATUDA, 5.0%; placebo, 2.3%). Dystonia Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first-generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups. In the short-term, placebo-controlled clinical trials, dystonia occurred in 4.2% of LATUDA-treated subjects (0.0% LATUDA 20 mg, 3.5% LATUDA 40 mg, 4.5% LATUDA 80 mg, 6.5% LATUDA 120 mg and 2.5% LATUDA 160 mg) compared to 0.8% of subjects receiving placebo. Seven subjects (0.5%, 7/1508) discontinued clinical trials due to dystonic events four were receiving LATUDA 80 mg/day and three were receiving LATUDA 120 mg/day. Other Adverse Reactions Observed During the Premarketing Evaluation of LATUDA Following is a list of adverse reactions reported by patients treated with LATUDA at multiple doses of 20 mg once daily during any phase of a study within the database of 2905 patients. The reactions listed are those that could be of clinical importance, as well as reactions that are plausibly drugrelated on pharmacologic or other grounds. Reactions listed in Table 5 or those that appear elsewhere in the LATUDA label are not included. Although the reactions reported occurred during treatment with LATUDA, they were not necessarily caused by it. Reactions are further categorized by organ class and listed in order of decreasing frequency according to the following definitions: those occurring in at least 1/100 patients (frequent) (only those not already listed in the tabulated results from placebo-controlled studies appear in this listing); those occurring in 1/100 to 1/1000 patients (infrequent); and those occurring in fewer than 1/1000 patients (rare). Blood and Lymphatic System Disorders: Infrequent: anemia Cardiac Disorders: Frequent: tachycardia; Infrequent: AV block 1st degree, angina pectoris, bradycardia Ear and Labyrinth Disorders: Infrequent: vertigo Eye Disorders: Frequent: blurred vision Gastrointestinal Disorders: Frequent: abdominal pain, diarrhea; Infrequent: gastritis General Disorders and Administrative Site Conditions: Rare: sudden death Investigations: Frequent: CPK increased Metabolism and Nutritional System Disorders: Frequent: decreased appetite Musculoskeletal and Connective Tissue Disorders: Rare: rhabdomyolysis Nervous System Disorders: Infrequent: cerebrovascular accident, dysarthria Psychiatric Disorders: Infrequent: abnormal dreams, panic attack, sleep disorder; Renal and Urinary Disorders: Infrequent: dysuria; Rare: renal failure Reproductive System and Breast Disorders: Infrequent: amenorrhea, dysmenorrhea; Rare: breast enlargement, breast pain, galactorrhea, erectile dysfunction Skin and Subcutaneous Tissue Disorders: Frequent: rash, pruritus; Rare: angioedema Vascular Disorders: Frequent: hypertension 7 DRUG INTERACTIONS 7.1 Potential for Other Drugs to Affect LATUDA LATUDA is predominantly metabolized by CYP3A4. LATUDA should not be used in combination with strong inhibitors or inducers of this enzyme [see Contraindications (4)] and dose should be limited when used in combination with moderate inhibitors of CYP3A4 [see Dosage and Administration (2.4)]. No dose adjustment is needed with concomitant use of lithium (see Figure 1). Figure 1: Impact of Other Drugs on LATUDA Pharmacokinetics Interacting drug PK Strong CYP3A4 Inhibitor Ketoconazole 400 mg/day Cmax AUC Moderate CYP3A4 Inhibitor Diltiazem Cmax 240 mg/day AUC Strong CYP3A4 Inducer Rifampin Cmax 600 mg/day Lithium 600 mg BID AUC Cmax AUC Fold Change and 90% CI Change relative to lurasidone alone Recommendation Should not be coadministered Starting dose = 20 mg Maximum dose = 80 mg Should not be coadministered Adjustment not required 7.2 Potential for LATUDA to Affect Other Drugs No adjustment is needed on the dose of lithium, or substrates of P-gp or CYP3A4 when coadministered with LATUDA (Figure 2). Figure 2: Impact of LATUDA on Other Drugs Interacting drug PK P-gp Substrates Digoxin 0.25 mg SD Cmax AUC CYP3A4 Substrates Midazolam Cmax 5 mg SD AUC Oral Contraceptive Fold Change and 90% CI Recommendation Adjustment not required Adjustment not required Ethinyl Cmax Adjustment Estradiol not required AUC Norelgestromin Cmax Adjustment not required AUC Lithium 600 mg BID* Ctrough Adjustment not required Change Relative to Interactive Drug Alone *Steady state lithium Ctrough on Day 4 vs Day 8 when lithium was coadministered with lurasidone at steady state 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Teratogenic Effects Pregnancy Category B LATUDA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Non-teratogenic Effects Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Safe use of LATUDA during pregnancy or lactation has not been established; therefore, use of LATUDA in pregnancy, in nursing mothers, or in women of childbearing potential requires that the benefits of treatment be weighed against the possible risks to mother and child.

11 Animal Data No adverse developmental effects were seen in a study in which pregnant rats were given LATUDA during the period of organogenesis and continuing through weaning at doses up to 10 mg/kg/day; this dose is approximately half of the MRHD based on body surface area. No teratogenic effects were seen in studies in which pregnant rats and rabbits were given LATUDA during the period of organogenesis at doses up to 25 and 50 mg/kg/day, respectively. These doses are 1.5- and 6- times, in rats and rabbits respectively, the maximum recommended human dose (MRHD) of 160 mg/day based on body surface area. 8.3 Nursing Mothers LATUDA was excreted in milk of rats during lactation. It is not known whether LATUDA or its metabolites are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, considering risk of drug discontinuation to the mother. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of LATUDA in the treatment of schizophrenia did not include sufficient numbers of patients aged 65 and older to determine whether or not they respond differently from younger patients. In elderly patients with psychosis (65 to 85), LATUDA concentrations (20 mg/day) were similar to those in young subjects [see Clinical Pharmacology (12.3)]. No dose adjustment is necessary in elderly patients (Figure 2). Elderly patients with dementia-related psychosis treated with LATUDA are at an increased risk of death compared to placebo. LATUDA is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning]. 8.6 Other Patient Factors The effect of intrinsic patient factors on the pharmacokinetics of LATUDA is presented in Figure 3. Figure 3: Impact of Other Patient Factors on LATUDA Pharmacokinetics PK Renal impairment Mild Cmax AUC Moderate Cmax AUC Severe Cmax AUC Hepatic impairment Mild Cmax AUC Moderate Cmax AUC Severe Cmax AUC Population description Fold Change and 90% CI Recommendation Adjustment not required Starting dose = 20 mg Maximum dose = 80 mg Starting dose = 20 mg Maximum dose = 80 mg Adjustment not required Starting dose = 20 mg Maximum dose = 80 mg Starting dose = 20 mg Maximum dose = 40 mg Gender Females Race Asian* Cmax AUC Cmax AUC Adjustment not required Adjustment not required Change relative to reference *Compare to Caucasian 10 OVERDOSAGE 10.1 Human Experience In premarketing clinical studies involving 2905 patients, accidental or intentional overdosage of LATUDA was identified in one patient who ingested an estimated 560 mg of LATUDA. This patient recovered without sequelae. This patient resumed LATUDA treatment for an additional two months Management of Overdosage Consult a Certified Poison Control Center for up-to-date guidance and advice. There is no specific antidote to LATUDA, therefore, appropriate supportive measures should be instituted and close medical supervision and monitoring should continue until the patient recovers. Cardiovascular monitoring should commence immediately, including continuous electrocardiographic monitoring for possible arrhythmias. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of additive QT-prolonging effects when administered in patients with an acute overdose of LATUDA. Similarly, the alpha-blocking properties of bretylium might be additive to those of LATUDA, resulting in problematic hypotension. Hypotension and circulatory collapse should be treated with appropriate measures. Epinephrine and dopamine should not be used, or other sympathomimetics with beta-agonist activity, since beta stimulation may worsen hypotension in the setting of LATUDA-induced alpha blockade. In case of severe extrapyramidal symptoms, anticholinergic medication should be administered. Gastric lavage (after intubation if patient is unconscious) and administration of activated charcoal together with a laxative should be considered. The possibility of obtundation, seizures, or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis. Manufactured for: Sunovion Pharmaceuticals Inc. Marlborough, MA USA For Customer Service, call For Medical Information, call To report suspected adverse reactions, call R0X LATUDA is a registered trademark of Dainippon Sumitomo Pharma Co. Ltd. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co. Ltd Sunovion Pharmaceuticals Inc.

12 PSYCHIATRIC NEWS Copyright 2013, American Psychiatric Association Psychiatric News, ISSN , is published bi-weekly on the first and third Friday of each month by the American Psychiatric Association, 1000 Wilson Boulevard, Arlington, Va Periodicals postage paid at Arlington, Va., and additional mailing offices. Postmaster: send address changes to Psychiatric News, APA, Suite 1825, 1000 Wilson Boulevard, Arlington, Va Online version: ISSN CONTENTS 7 SUBSCRIPTIONS U.S.: individual, $123. International: APA member, $167; nonmember, $184. Single issues: U.S., $24; international, $41. Institutional subscriptions are tier priced. For site licensing and pricing information, call (800) or institutions@psych.org. OFFICERS OF THE ASSOCIATION Dilip Jeste, M.D., President Jeffrey Lieberman, M.D., President-elect David Fassler, M.D., Treasurer Roger Peele, M.D., Secretary Scott Benson, M.D., Speaker of the Assembly James H. 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Those who submit letters to the editor and other types of material for Psychiatric News are agreeing that APA has the right, in its sole discretion, to use their submission in print, electronic, or any other media PROFESSIONAL NEWS 9 DSM-5 Gender Dysphoria Diagnosis Gets Chapter to Itself The diagnosis of gender dysphoria will emphasize a person s sense of incongruence with natal gender rather than cross-gender behavior, as with gender identity disorder in DSM-IV. 11 Combat Veterans Explain Why They Avoid Mental Health Care Stigma is less of a concern for troops returning from Iraq or Afghanistan than use of medications or lack of readiness for mental health treatment. 12 Innovative Collaborative-Care Model Outperforms Traditional One Telepsychiatry is an important and effective addition when incorporated into management of depression in small rural primary care clinics. 14 Insurer Accused of Denying Coverage for Needed Care APA and one of its district branches are protesting what they say are violations of the federal parity law and other laws by a major insurer. 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13 8 Diversity: What Can Psychiatry Do? BY DILIP JESTE, M.D. Wikipedia mentions more than a dozen types of diversity. The type most relevant to psychiatry is multiculturalism (ethnic diversity), the promotion of multiple ethnic cultures. Multiculturalism is often contrasted with the concept of assimilationism and has been described as a salad bowl or cultural mosaic rather than a melting pot. The best descriptive summary of such diversity is by Gladstone (gladstone. uoregon.edu/~asuomca/diversityinit/ definition.html), according to which diversity encompasses acceptance, respect, and understanding that each individual is unique, while recognizing individual differences in terms of race, ethnicity, gender, sexual orientation, age, religious beliefs, and so on. It is the exploration of these differences in a safe, positive, and nurturing environment. Acceptance of diversity doesn t come naturally. At the regional brain level, it may be conceived of, in a simplistic manner, as a conflict between dorsolateral prefrontal cortex (the rational, cold-calculating, self-serving part) and ventromedial prefrontal cortex (compassionate, sensitive, otherdirected part). It is only by training, role modeling, and practicing that we learn to be tolerant of diversity. We then find out, however, that diversity is invaluable from both rational and compassionate perspectives and that there should be no conflict between these two tendencies. I invited my long-time friend and respected colleague Carl Bell, M.D., to discuss diversity as it applies to psychiatry and to suggest ways in which APA can seek to enhance diversity. Below is his thoughtful and thought-provoking commentary. Dr. Bell is director of the Institute for Juvenile Research in the Department of Psychiatry, College of Medicine, University of Illinois at Chicago. Cultural Humbleness, Awareness Needed in Psychiatry BY CARL C. BELL, M.D. We hold these truths to be self-evident, that all men are created equal, that they are endowed by their creator with certain unalienable Rights, that among these are Life, Liberty, and the pursuit of Happiness. Although these rights were originally intended to be unalienable for European- American men, America s ideal is that we judge people by content of their character, and not the color of their skin, country of origin, gender, class, culture, religion, sexual orientation, age, or other external identifiers. Unfortunately, our brains are designed to differentiate and avoid people that we perceive as different from us, and we are prone to stereotype, fear, project negative attributions, avoid, and shun those who are others. Therefore, despite electing an African-American president for two terms, America continues to fall short of its ideals. As psychiatrists, we should understand how our limbic system drives us, and we should strive to be equally or more driven by our more mature, frontal-lobe systems instead of automatically reverting to our default when confronted by the other. We do this by first understanding that race is a biological fallacy. Race is a social construct based on human biology or mental functioning causing human beings to automatically stereotype ( psychiatryonline. org/article.aspx? articleid=157092). Similarly, people s other external characteristics give us primordial reasons to identify people as not us and to exclude them from our lives. Our American ideals and goals dictate this is unfair and unreasonable. Second, we should understand that for centuries before America existed, cultures much older than ours have been struggling with psychiatric and behavioral disorders, and, accordingly, we need to understand there is much we can learn from other cultures corrective, protective, and strengthbased practices. It is ethnocentric to think American psychiatry has all the answers. Our 21st-century communication is virtually shrinking Earth, and other cultures wisdom is at risk for being lost, hopefully to be rediscovered later so why should we be so arrogant as to not remember the past so we can be condemned to repeat it. Too many of us scoff at ancient traditions and cultures as not being directionally correct. Of course, it is difficult for us to develop a critical mass of scholars who are conversant with different cultural practices that strengthen and preserve that culture s people ( com/views/commentaries/singlearticle/the-power-of-culture/ dcaf50d064a0a9f021f3dbd31fee100c. html). Psychiatrists from different cultural and ethnic backgrounds are at risk for being isolated from each other; thus those of us who understand the importance of culture and ethnicity tend to be alone in the new emphasis on biological psychiatry. As psychiatrists, we need to create a cultural emphasis on diversity within our ranks. At a recent American College of Psychiatry meeting, Dale Walker, a Native-American psychiatrist and colleague for 30 years, lamented the difficulty of developing a critical mass of culturally and ethnically aware psychiatrists who can study and fill the gaps in cultural, racial, and ethnic psychiatric knowledge. The notion of using the Internet to create a virtual critical mass surfaced, and APA resources could remediate this problem. Such a learning collaborative could inform all of us regardless of our culture of origin. A lesson from biology tells us that an ecotone is the area where ecological zones meet a transition zone from one ecological zone to another. It turns out that ecotones are rich in diversity that enhances capacity for learning and biologic innovations. As psychiatrists, we need to heighten our cultural humility. Our Western culture needs practice being humble, and, while some would say humility is an oxymoron that is antithetical to American culture, we have that capacity innovation is a Western cultural value. We could have been so much further along had we been more open to diverse ideas and practices, for example, mindfulness (a central feature of East-Indian culture); the understanding that change is a fundamental part of life (a central feature of Asian culture). We would be more comfortable embracing spirituality as a legitimate mental process (a central feature of African-American culture) instead of a pathological oceanic feeling. If we were more humble, we would be quicker to understand that exercise stimulates neurogenesis, three-ball-cascade juggling increases connectivity, the environment shapes genetic expression, cerebellar stimulation fosters cerebral development, and family-strengthening techniques (a central feature of Latino culture) can prevent risky youth behaviors. Being more culturally humble would have lessened Western medicine s fascination with risk factors often to the exclusion of protective factors, sooner a struggle we continue to be embroiled in. Lastly, we need to make a more substantial investment in global mental health and stop thinking Americans are the only ones who count on the planet. PN

14 PROFESSIONAL NEWS 9 New Gender Dysphoria Criteria Replace GID New criteria for gender dysphoria will emphasize the individual s felt sense of incongruence with natal gender, rather than crossgender behavior. This article is part of a series on the differences between DSM-IV and DSM-5. The series will run through May, when the manual will be published. BY MARK MORAN G ender dysphoria is a new diagnostic class in DSM-5 and a chapter unto itself replacing the DSM-IV diagnosis of gender identity disorder and reflecting a new conceptualization of individuals who seek treatment for problems related to gender. Criteria for the new category emphasize the phenomenon of gender incongruence rather than cross-gender identification, as was the case in DSM-IV. By separating it from sexual dysfunctions and paraphilias (with which it had previously been included in DSM-IV in a chapter titled Sex and Gender Identity Disorders ), work group members said they hope to diminish stigma attached to a unique diagnosis that is used by mental health professionals but for which treatment often involves endocrinologists, surgeons, and other professionals. Preorder Your DSM-5 Now! DSM-5 and related titles may be preordered at org/searchcenter/pages/default. aspx?k=2555. Also, attendees at the 2013 annual meeting in May will have an exclusive opportunity to purchase DSM-5 before it goes on sale to the public. The manual will be available in the American Psychiatric Publishing Bookstore in the Exhibit Hall in the Moscone Convention Center. Those who come to the bookstore on Saturday, May 18, from 4 p.m. to 5 p.m., can meet the DSM-5 Task Force chairs and receive a free gift with purchase. (See the box on page 19 for meeting registration information.) Whether buying online or in person, APA members are eligible for a discount. Key Points Gender Dysphoria A new category and separate chapter for gender dysphoria emphasizes the phenomenon of gender incongruence rather than cross-gender identification. Gender dysphoria is now separate from the chapters on sexual dysfunctions and on paraphillic disorders. The category is reconceptualized as one overarching diagnosis with separate developmentally appropriate criteria sets for children and for adolescents and adults. For children, adolescents, and adults, a specifier is included for individuals whose condition is related to a disorder of sex development (DSD) such as congenital adrenal hyperplasia; in DSM-IV the presence of a DSD or intersex condition was exclusionary for diagnosis of gender identity disorder. For adolescents and adults, a specifier is also included for individuals who have transitioned to full-time living in the desired gender. For children, a strong desire to be of the other gender or an insistence that he or she is the other gender is now necessary but not sufficient to meet the diagnosis, making the diagnosis more restrictive and conservative. Sexual Dysfunctions The chapter on sexual dyfunctions will include gender-specific sexual dysfunctions. Female sexual desire and arousal disorders have been combined into one disorder: female sexual interest/arousal disorder. Paraphillic disorders (previously included in the DSM-IV chapter titled Sex and Gender Identity Disorders ) have been split off into a separate chapter. All of the DSM-5 sexual dysfunctions except substance-/medication-induced sexual dysfunction now require a minimum duration of approximately six months to improve precision regarding duration and severity criteria and to reduce the likelihood of overdiagnosis. (The chapter devoted to gender dysphoria follows the chapter titled Sexual Dysfunctions. That chapter is marked by the addition of gender-specific sexual dysfunctions and the combination of female sexual desire and arousal disorders into a new disorder, female sexual interest/arousal disorder. Additionally, the paraphillic disorders that had previously appeared with gender identity disorder (GID) in the DSM-IV chapter titled Sex and Gender Identity Disorders have been split off into a separate chapter that appears later in the manual. And to improve precision regarding duration and severity and to reduce the likelihood of overdiagnosis, all of the DSM-5 sexual dysfunctions except substance-/medication-induced sexual dysfunction now require a minimum duration of approximately six months.) Meanwhile, refinements to intermittent explosive disorder, conduct disorder, and oppositional defiant disorder mark the major changes to the chapter titled Disruptive, Impulse-Control, and Conduct Disorders. The chapter, bringing together disorders marked by problems in emotional and behavioral selfcontrol, combines disorders previously classified in DSM-IV under disorders of infancy, childhood, and adolescence, along with other impulse control disorders pyromania and kleptomania not confined by age (see page 10). The three chapters Sexual Dysfunctions, Gender Dysphoria, and Disruptive, Impulse-Control and Conduct Disorders are the 12th, 13th, and 14th chapters that will appear in Section II of DSM-5, to be published in May. While the new manual includes much that is familiar, important differences not only in criteria for individual disorders, but in the organization of the text will be readily apparent. The changes reflect an effort begun more than a decade ago to respond to challenges posed by research and clinical experience to previous editions of the manual including high rates of comorbidity within and across DSM chapters, an excessive use of and reliance on not otherwise specified (NOS) criteria, and a growing inability to integrate DSM disorders with the findings from genetic and other research. Some of the overarching conceptual ideas that have informed the development of diagnostic criteria and the organization of the text include incorporation of a developmental approach to psychiatric disorders, recognition of the influence of culture and gender on how psychiatric illness presents in individual patients, a move toward the use of dimensional measures to rate severity and disaggregate symptoms that tend to occur across multiple disorders, harmonization of the text with ICD, and integration of genetic and neurobiological findings by grouping clusters of disorders that share genetic or neurobiological substrates. DSM-5 consists of three sections: Section I gives an introduction to DSM-5 with instructions on how to use the manual; Section II outlines the categorical diagnoses according to a revised chapter organization that eliminates the multiaxial system; and Section III includes conditions that require further research before their consideration as formal diagnoses, as well as cultural formulations and other information. Jack Drescher, M.D., a member of a subgroup that helped formulate criteria for gender dysphoria, explained that a central tension in discussions about the diagnosis was between the possibly stigmatizing effect of retaining a category for gender conflicts among a list of mental disorders and the need to maintain access to care for individuals who do experience distress or impairment in function with regard to gender conflicts. We decided the access-to-care issue was very important, Drescher told Psychiatric News. If you take out the diagnosis, you don t have a code for treatment. But Drescher said the removal of the diagnosis from the chapter including sexual dysfunctions and the separation of paraphillic disorders into its own chapter in DSM-5 should serve to lessen stigma associated with the diagnosis. Also, he said the name change to gender dysphoria is an effort to reflect the individual s felt sense of incongruence with natal gender, as opposed to pathologizing gender-atypical behavior. Drescher said the category is reconceptualized as one diagnosis with separate developmentally appropriate criteria sets for children and for adolescents and adults. For both groups, the criteria include a specifier to indicate whether the individual s condition is related to a disorder of sex development (DSD) such as congenital adrenal hyperplasia; this is in contrast to DSM-IV in which the presence of a DSD or intersex condition was an exclusionary criterion for the diagnosis of GID. The criteria for adolescents and adults also include a specifier to indicate whether the individual has transitioned to full-time living in the desired gender. And for children, Criterion A1 ( a strong desire to be of the other gender see Gender Dysphoria on page 14

15 10 PSYCHIATRIC NEWS APRIL 5, 2013 PROFESSIONAL NEWS New DSM Chapter to Focus On Disorders of Self-Control The chapter on disruptive disorders brings together diagnoses previously classified as disorders of childhood and adolescence with other disorders of self-control not limited by age. BY MARK MORAN Refinements to oppositional defiant disorder (ODD), conduct disorder, and intermittent explosive disorder mark the prominent changes clinicians will see in a new chapter in DSM-5 on Disruptive, Impulse-Control, and Conduct Disorders. The chapter brings together disorders marked by problems with emotional and behavioral self-control that were previously included in the chapter in DSM-IV titled Disorders Usually First Diagnosed in Infancy, Childhood, or Adolescence (ODD, conduct disorder, and intermittent explosive disorder) and other disorders of self-control not confined to childhood, such as pyromania and kleptomania. Because of significant overlap with antisocial personality disorder, the latter appears in the disruptive disorders chapter as well as in the chapter on personality disorders. (Attention-deficit/ hyperactivity disorder, whose symptoms also overlap with many of the disorders in this chapter, appears in the chapter on neurodevelopmental disorders; see Psychiatric News, January 18.) All of these disorders have previously been identified as externalizing as compared to internalizing disorders, explained Darrel Regier, M.D., M.P.H., APA director of research and vice chair of the DSM-5 Task Force. Since we eliminated a section that included only disorders of childhood and adolescence in order to distribute these to disorder sections that would cover the entire lifespan, putting ODD and conduct disorder together with antisocial personality disorder, intermittent explosive disorder, pyromania, and kleptomania was appropriate. Four refinements mark changes to criteria for oppositional defiant disorder. Symptoms are now grouped into three types: angry/irritable mood, argumentative/defiant behavior, and vindictiveness, reflecting that the disorder includes both emotional and behavioral symptoms. The exclusion criterion for conduct disorder has been removed. You can have both conduct disorder and ODD, Francisco Castellanos, M.D., a member of the Work Group on Disruptive Disorders, told Psychiatric News. It s not as simple as you graduate from one to the other. Additionally, the criteria will indicate that symptoms must be present more than once a week to distinguish the diagnosis from symptoms common to normally developing children and adolescents. And a severity rating has been added to the criteria to reflect research Key Points showing that the degree of pervasiveness of symptoms across settings is an important indicator of severity. Castellanos explained that the work group considered whether children who showed only symptoms of ODD toward one particular member of the family, for instance, would still meet the criteria. Turns out the predictive validity is the same, he said. But what does seem to matter is the severity of prognosis. If a child displays only this behavior toward mother, it turns out that is better prognostically than if the child displays the behavior pervasively. So it seems that the number of different settings in which the symptoms appear is a very reasonable indicator of severity. see Self-Control on page 17 Disorders of Self-Control A new chapter on disruptive, impulse control, and conduct disorders brings together disorders reflecting deficits in emotional and behavioral self-control. It includes disorders previously classified as disorders of childhood or adolescence, and other disorders of self-control not confined to age. Symptoms of oppositional defiant disorder are grouped into three types: angry/ irritable mood, argumentative/defiant behavior, and vindictiveness, reflecting that the disorder includes both emotional and behavioral symptomatology. Criteria for intermittent explosive disorder have been made considerably more specific with regard to frequency, severity, and type of symptoms than previous DSM-IV criteria. Criteria for conduct disorder include a specifier for identifying those children with the disorder who are deficient in pro social behaviors. Evidence of the latter is believed to indicate a more severe prognosis and a different treatment approach. Sexual Dysfunction, Gender Dysphoria, Self-Control Disorders This column includes questions concerning sexual dysfunction, gender dysphoria, and disruptive, impulse-control, and conduct disorders. A number of changes occurred in DSM-5 concerning these disorders. In contrast to DSM-IV, gender-specific sexual dysfunctions have been added and, for females, sexual desire and arousal disorders have been combined into one disorder (female sexual interest/arousal disorder). Gender dysphoria is new in DSM-5 and reflects a change in conceptualization of its defining features by emphasizing the phenomenon of gender incongruence rather than cross-gender identification per se, as was the case in DSM-IV gender identity disorder. The chapter on disruptive, impulse control, and conduct disorders is new to DSM-5. It combines disorders that were previously included among disorders usually first diagnosed in infancy, childhood, adolescence, or impulse-control disorders not otherwise specified (that is, oppositional defiant disorder; conduct disorder; other specified and unspecified; disruptive, impulse-control, and conduct disorders; and intermittent explosive disorder). These disorders are all characterized by problems in emotional and behavioral self-control. The answers to the questions below and rationales are posted at Examination_QandA_2.pdf. 1. Sexual dysfunction: Which of these describes a condition or disorder that would be properly diagnosed as other specified sexual dysfunction? a) Medical-induced sexual dysfunction b) Sexual aversion c) Erectile dysfunction d) Female sexual interest/arousal disorder e) Delayed ejaculation 2. Gender dysphoria: Which of the following diagnoses has been eliminated in DSM-5? a) Gender identity disorder b) Borderline personality disorder c) Gender dysphoria d) Pedophilic disorder e) Transvestic disorder 3. Disruptive, impulse-control, and conduct disorders: A 16-year-old boy with a long history of defiant behavior toward authority figures also has associated aggression toward peers (gets into fights at school), his parents, and objects (punching holes in walls, breaking doors). Furthermore, he has begun to steal from stores and his parents (money, jewelry), and he frequently lies. He does not seem pervasively irritable or depressed, and has no sleep disturbance or psychotic symptoms. What is the likely DSM-5 diagnosis for this patient? a) Oppositional defiant disorder b) Conduct disorder c) Attention-deficit/hyperactivity disorder d) Major depressive disorder e) Disruptive mood dysregulation disorder These questions are from DSM-5 Self-Exam Questions: Test Questions for the Diagnostic Criteria, which may be preordered from American Psychiatric Publishing at org/searchcenter/pages/searchdetail. aspx?itemid= The book, available in August, contains 500 questions for all the categories of psychiatric disorders and includes Section III. PN

16 PROFESSIONAL NEWS 11 Expectations Deter Vets From Mental Health Care U.S. veterans of the Iraq and Afghanistan wars say they worry more about psychiatric medications than stigma in avoiding treatment. BY AARON LEVIN B arriers to treatment of posttraumatic stress disorder (PTSD) among troops returning from the wars in Iraq and Afghanistan remain complex, even after years of educational efforts by military and veterans health officials. Researchers held extended (45-60 minute) phone conversations with 143 service members who had served in the war zones and who had screened positive for PTSD but were not in treatment. The goal was to learn their reasons for not entering care. Many expressed concerns about the treatment they thought they would receive. About 40 percent of troops interviewed for a study published in the March Psychiatric Services said they did not seek treatment for mental health problems because they disliked the possible options that such care entails. They disliked group therapy, believed that they would be misunderstood by clinicians, or assumed that they would be prescribed medications but believed that medications alone would not relieve their symptoms. They did not understand how a medicine would help treat their trauma, said lead researcher Tracy Stecker, Ph.D., an assistant professor of family and community medicine at Dartmouth Medical School, in an interview with Psychiatric News. They worried that a clinician would simply prescribe a drug instead of listening to the patient s personal history of trauma. However, the veterans mentioned stigma as a barrier only 16 percent of the time, and logistical problems (such as travel time to clinics) were cited by only 8 percent of study participants. As part of their qualitative study, the researchers asked the troops what they thought might help them. If they said talk, then we discussed with them the barriers to cognitive-behavioral therapy, said Stecker. Our purpose was to get them to be realistic about their expectations of available treatments. In addition to the 40 percent who said they avoided care because they did not like the treatment options, another 35 percent stated that they did not need treatment and were not emotionally ready to begin therapy, even though they had PTSD symptoms. In those cases, Stecker s group suggested that perhaps taking an hour to talk about trauma might be a relief from spending 24 hours a day not talking about it. Many troops acknowledged a need for treatment but said they would rather wait until they left military service for fear that entering care would compromise their careers or security clearances. Stecker was surprised to learn that only 1 in 6 of the respondents said stigma was a major barrier to treatment. PTSD has become a kind of badge of honor, she said. One soldier even told her that he used the diagnosis as a pickup line in bars, telling sympathetic women, I have PTSD and I need to get help. Ten years ago, acknowledging that diagnosis would have been unthinkable, but not today. A decade of education and discussion in the U.S. Armed Forces about PTSD appears to be changing attitudes, she said. People are not getting into trouble within the military for being real about having PTSD. However, she cautioned, such openness did not extend to other conditions, such as depression or substance abuse, which might also have their origins in combat trauma. One thing the interviewing process revealed, Stecker said, was the importance of taking the opportunity to open a discussion about longer-term change. You can talk to these guys on an individual basis and get them to modify their choices and get them into treatment, she pointed out. And we can do more to support them while they re resisting. A second study in the March Psychiatric Services appears to back up some of Stecker s conclusions. Eunice Wong, Ph.D., of the RAND Study of Trauma Treatment in Children Proves Controversial A comparative effectiveness review concludes that there is not enough evidence backing the use of particular treatments for children after disasters. Vets Give Reasons for Avoiding Care Iraq or Afghanistan war veterans have concerns about treatment for posttraumatic stress disorder (N=143 troops; 189 beliefs recorded). Concerns about treatment Emotional readiness Stigma Logistical issue N=15 Source: Tracy Stecker, Ph.D., et al., Psychiatric Services, March 2013 N=31 16% 8% N= Frequently reported beliefs Valerie Forman-Hoffman, Ph.D., M.P.H. Corporation and colleagues found that in a sample of 1,659 active-duty service members, 17 percent had received mental health treatment in the prior 12 months. About 14 percent had seen a specialty mental health clinician, and 5 percent had sought help from a primary care provider. (Some may have seen both types of clinicians.) Patients who saw the mental health specialists reported more visits (10.3 per year on average) and higher satisfaction with their care than did those only in primary care (5.3 visits per year). [S]ervice members may prefer the types of interventions that are more widely available from mental health providers (psychotherapy) than from primary care providers (medication), a preference reflecting similar patterns among the U.S. population at large, Wong suggested. PN N=76 35% 40% An abstract of Treatment- Seeking Barriers for Veterans of the Iraq and Afghanistan Conflicts Who Screen Positive for PTSD is posted at psychiatryonline.org/article. aspx?articleid= An abstract of Mental Health Treatment Experiences of U.S. Service Members Previously Deployed to Iraq and Afghanistan is posted at ps.psychiatryonline.org/ article.aspx?articleid= BY AARON LEVIN D espite the attention paid to the mental health of children who survive terrorism, community violence, or natural disasters, too little is still known for certain about how to help them, according to a comparative effectiveness review. However, some child psychiatrists who care for and study children who have experienced trauma have their reservations about the review s conclusions. The reviewers sifted through 6,647 abstracts but found only 21 trials and one cohort study that met their strict inclusion criteria. The review covered only nonrelational trauma terrorism, community or school violence, natural disasters, or death of loved ones. A study (now in press) by the same group will address child maltreatment and domestic violence, termed relational trauma. Interventions in the studies included several variants on cognitive-behavioral therapy (CBT), including traumafocused CBT, child and family traumatic stress intervention (CFTSI), and Enhancing Resiliency Among Students Experiencing Stress (ERASE). Those psychotherapeutic approaches do show some benefit compared with no treatment, but there was insufficient evidence for posttraumatic use of medications, concluded Valerie Forman-Hoffman, Ph.D., M.P.H., a research epidemiologist at RTI International in Research Triangle Park, N.C., and colleagues in the March Pediatrics. Overall, the evidence base was not strong enough to recommend best treatment practices, according to Forman- Hoffman. The conclusions leave practitioners in a quandary about how they can be helpful, said trauma expert Frederick Stoddard, M.D., a clinical professor of psychiatry at Harvard Medical School and a psychiatrist at Massachusetts General Hospital. Frankly, a more positive framing of the conclusions might have been more helpful. But the review should not leave pediatricians with the impression that little can be done to help children who have undergone trauma, Forman-Hoffman told Psychiatric News. I certainly hope not, she said. We specifically tried to make it clear that while we cannot make a definitive conclusion, there is some evidence that points to the effectiveness of treatments that are CBT-based, including some delivered in school settings. see Trauma on page 30

17 12 PSYCHIATRIC NEWS APRIL 5, 2013 PROFESSIONAL NEWS Telepsychiatry Proves Crucial Adjunct in Primary Care A collaborative care model using telepsychiatry along with primary care improves response and remission in patients with depression in rural, underserved areas. BY AARON LEVIN T he usual model for collaborative mental health care locates specialists at primary care clinics, but including a full-time psychiatrist or psychologist at small practices, especially those in rural areas, can be impractical. With that in mind, researchers at the University of Arkansas compared depression care using that traditional collaborative approach with one using an off-site multiprofessional team and telepsychiatry. The practice-based collaborative care used the primary care clinicians and on-site nurse care managers at rural health centers to diagnose, treat, and follow patients. For the telemedicine-based collaborative care model, a team of psychiatrists, pharmacists, psychologists, and nurse care managers at the University of Arkansas for Medical Sciences in Little Rock backed up a second group of primary care providers, explained John Fortney, Ph.D., a professor and director of the Division of Health Services Research in the Department of Psychiatry, and colleagues in the February 22 AJP in Advance. The Arkansas team arranged with five federally qualified health centers in the poor and underserved Mississippi Delta and Ozark Highland areas of Arkansas to screen patients for depression. Local health center staff recruited 364 eligible patients and completed the baseline interviews. Those patients were then randomized to receive either practicebased or telemedicine-based care. To equalize things a bit, care managers at both locations were required to have no prior specialized mental health experience. Under the guidance of the specialists back at the university, clinicians in the telemedicine-based group were more likely than their practice-based counterparts to give patients information about depression or its treatment, ask them about symptoms, or ask if they were adhering to treatment. Together, at 12 months, they achieved greater reductions in depression symptom severity, better response and remission rates, and better quality of life than the local, practice-based staff did. Patients in the telemedicine model were also seven times more likely to report treatment response and 12 times more likely to achieve remission than were the practice-based patients. The fact that the telemedicine group produced better outcomes is big news, said Peter Yellowlees, M.D., a professor of psychiatry at the University of California, Davis, who was not involved with Fortney s study. In the past, studies only demonstrated that telepsychiatry was no worse than in-person care. The improved outcomes were achieved without increasing the number of primary care visits, said Fortney and colleagues. They ascribed the difference to higher fidelity to the care-manager protocol, despite having the initially similar background as the on-site care manager. Over time, the off-site care manager learned more about how to manage patients with depression through her interactions with the other members of the off-site depression care team [such as the pharmacist or psychiatrist], so by the end of the study she was probably more effective than the on-site care managers, said Fortney in an interview with Psychiatric News. It might be possible for an on-site care manager to gain such expertise by working with an offsite pharmacist, psychologist, and psychiatrist. That would be an interesting hypothesis to test. Telemedicine care managers also seemed to provide more encouragement to patients to engage in self-management activities such as exercise or social activity. There s no doubt that getting patients more involved in self-management produces better results, Yellowlees told Psychiatric News. The researchers found no significant differences in antidepressant medication prescriptions or medication adherence between the two groups. Team recommendations about medication changes were usually conveyed to the primary care provider rather than directly to the patient, said Fortney. However, only 17 percent participated in one telepsychotherapy session, and less than 8 percent completed a full eight-session course. I was very surprised by how few patients were willing to use the free psychotherapy that was available to them in their primary care clinic over interactive video, said Fortney. Patients were referred to a separate visit for telepsychiatric care, but better results might be achieved with a warm handoff from the primary care provider to the mental health professional, he said. One question in an era when health see Telepsychiatry on page 18 Effects of Bullying Don t End When School Does Young bullying victims are at risk of developing a mental illness. Victimization, however, may not be causal in predicting later outcomes in and of itself. BY JOAN AREHART-TREICHEL B ullying is not just a harmless rite of passage or an inevitable part of growing up, William Copeland, Ph.D., an associate professor of psychiatry at Duke University, and colleagues said in a report in the February 20 JAMA Psychiatry. Victims of bullying are at increased risk for emotional disorders in adulthood. This was the conclusion of Copeland and his colleagues after conducting what they described as the first study to explore prospectively the association Victims of school bullying are at risk of developing certain mental illnesses as young adults. between peer victimization in childhood and adult psychiatric diagnoses and suicidality. The study included approximately 1,400 subjects who were evaluated periodically during childhood, adolescence, and young adulthood to determine their involvement in bullying and symptoms of psychiatric disorders. The subjects were categorized as bullies, victims, bullies/victims, or neither (controls). Five percent were found to be bullies only, 22 percent were victims only, and 5 percent were both bullies and victims. The researchers assessed, after taking childhood hardship or psychiatric disorders into consideration, whether bullies, victims, or those who were both were more prone to developing psychiatric disorders as young adults than controls. As it turned out, all three groups of subjects involved in bullying were at higher risk for a psychiatric disorder than the controls. Compared with controls, those who had been bullies were four times more likely to have antisocial personality disorder. Youth who had been bullying victims were five times more likely to have agoraphobia, three times more likely to have generalized anxiety disorder, and three times more likely to have panic disorder. And youngsters who had been both bullies and victims were five times more likely to have major depressive disorder, 15 times more likely to have panic disorder, and in the case of males, 19 times more likely to be suicidal than their peers with no bullying involvement. see Bullying on page 17 O Driscoll Imaging /Shutterstock

18 PROFESSIONAL NEWS 13 Psychosomatic Medicine Becomes Deeper and Wider One trend in psychosomatic medicine is establishing integrated care in both the private and public sectors. For example, there is a mandate in the VA system to integrate primary and mental health care. BY JOAN AREHART-TREICHEL E ven in ancient times, physicians and philosophers had some sense of how thoughts and emotions influence the onset or maintenance of illness. Yet the modern era of psychosomatic medicine really started during the 1930s when researchers discovered fight-or-flight reactions to danger and how emotions could speed the heart or slow the gut. And since then, especially since the dawn of the 21st century, the field has become much more scientifically based, psychosomatic medicine experts say. One of the exciting findings in psychosomatic medicine in recent years has been the realization of how prevalent mental illnesses in medical patients are and how such comorbid mental illnesses can adversely affect medical outcomes, Robert Joseph, M.D., director of consultationliaison psychiatry at the Cambridge Health Alliance in Cambridge, Mass., told Psychiatric News. Those findings have brought home the importance of managing comorbid mental illnesses. They have also caught the attention of policymakers, such that comorbid mental illnesses are now much more readily accepted. That has influenced payment structure as well. Cases are often more complex than previously thought, another psychosomatic medicine expert, Thomas Wise, M.D., pointed out during an interview. In addition to being a professor of psychiatry at the Johns Hopkins and George Washington medical schools, Wise is medical director of behavioral health services at Inova Health Systems in Falls Church, Va. For instance, during the 1950s, you would see television ads of people getting stressed out and taking Tums to prevent stress-induced stomach ulcers, Wise recalled. But since then, we ve learned that stomach ulcers are due not just to stress, but to certain psychological characteristics, to certain behaviors, We have also learned that emotions are important in diseases that we never really thought about before heart disease being a clear example. and most crucially, to a bacterium called Helicobacter pylori. It could actually be this combination of factors that sets the stage for an ulcer, since 80 percent of the American population has H. pylori in their gut, but only a small number of them get ulcers from it. We have also learned that emotions are important in diseases that we never Practicing Psychosomatic Medicine Brings Challenges, Rewards One of the challenges of practicing in this field is that people don t know what psychosomatic medicine is, Linda Worley, M.D., a professor of psychiatry and obstetrics-gynecology at the University of Arkansas and president-elect of the Academy of Psychosomatic Medicine, said. They think it concerns only patients with unexplained symptoms, say those with a conversion disorder. But it is so much more than that. A major issue is communication, Isidore Berenbaum, M.D., associate director of the consultation-liaison service at Boston University, reported. With the HIPAA law and confidentiality, many of the primary care doctors often complain that when they send a patient to a psychiatrist, they don t know what happens. They kind of lose contact. We have to do a better job in communicating with them. One of the major challenges in practicing psychosomatic medicine is financial, because separate pots of money are allocated to treating psychiatric illnesses and medical illnesses, Thomas Wise, M.D., medical director of behavioral health services at Inova Health Systems in Falls Church, Va., stressed. Another hurdle is conducting research in this area because you have to find physicians who are willing to partner with you. Interesting Cases Described Isidore Berenbaum, M.D., associate director of the consultation-liaison service at Boston University, sometimes works with neurologists who are seizure experts. Once they asked him to meet with a young female patient who had epilepsy. She appeared to be having a seizure, yet her brain s electrical activity showed no evidence of it. It turned out that the patient had recently had a miscarriage and had converted her psychological trauma over it into a pseudoseizure. It became apparent that her grief was not being addressed, Berenbaum said. We gave her psychotherapy and talked with her family. That really helped her. Some time ago, a woman kept coming to the emergency room of the hospital where Linda Worley, M.D., a professor of psychiatry and obstetrics-gynecology at the University of Arkansas, worked. The woman would arrive with terrible wound infections. Somebody mentioned that they had heard of a similar case in another town that sounded very much like this person, Worley recalled. We suspected she had Munchausen syndrome, in which a person pretends to be ill, but really isn t. We finally confronted her and searched her belongings. We found dental syringes containing organisms that she would inject into her body. She got better while under our observation, and we referred her to outpatient treatment. Munchausen syndrome is very rare, Worley said. Individuals who have it often experienced significant voids in their lives. The focused attention and concern of a powerful authority figure, e.g., their doctor, fulfill this inner hunger. These patients medical presentations are without question some of the most fascinating you ll ever encounter. really thought about before heart disease being a clear example, Wise continued. We now know that people who are depressed after having a heart attack are at a three- to five-fold increased risk of dying than those who are not depressed after a heart attack. That is a really important finding because it means that you should screen for depression in all patients who have had heart attacks. And I m not sure that it s done on a regular basis across the board. In recent years, several studies have evaluated whether SSRI antidepressants could counter depression following a heart attack, Isidore Berenbaum, M.D., associate director of the consultationliaison service at Boston University, told Psychiatric News. Unfortunately the results haven t been as satisfactory as we had hoped, he said. But that is a place, I think, where a lot more work is going to be done. When it comes to the rewards of practicing psychosomatic medicine, one is the increasing recognition of the value of psychiatric care within medical care, Robert Joseph, M.D., director of consultation-liaison psychiatry at the Cambridge Health Alliance in Massachusetts, pointed out. Another reward is working alongside our medical colleagues, not being siloed like some in psychiatry are. Assisting fellow physicians is also gratifying, Berenbaum noted. I spend a lot of time working with oncologists and helping them deal with losing their patients.... I also help residents deal with anxiety, depression, and burnout. Practicing psychosomatic medicine keeps your medicine alive, Worley said. You need to stay up on things you learned in medical school. It can also give you an entrée to some interesting new types of work. For instance, I was recruited by a physician-owned medical malpractice company to create professional movies and educational curriculum portraying difficult patients and difficult medical colleagues and how to best manage them. I got to teach this curriculum to more than 8,000 physicians and their staffs throughout the mid-south. Still another vital discovery, he pointed out, is the role that anxiety and depression play in irritable bowel syndrome. Being able to use low doses of the SSRI antidepressants has made a big difference in the lives of people with the syndrome, he said. Several other research areas in psychosomatic medicine psychoneuroimmunology (Psychiatric News, August 3, 2012) and the role of distress in cancer (Psychiatric News, March 16, 2012) are also leading to valuable findings, Wise noted. In recent years, the field has also expanded its scope of practice, several psychosomatic medicine experts reported. Programs to treat and prevent delirium have been established in hospitals, Joseph said. And there have been even more dramatic changes in the ambulatory world. A generation ago, there was very little ambulatory involvement in psychosomatic medicine. But now there are increasing models of ambulatory care delivery by psychosomatic medicine that involve chronic disease management. There is also a trend toward stepped care, Wise said. Stepped care means you don t wait for a patient to come to you when depressed or anxious. You screen a whole population for, say, depression or anxiety. And those who are depressed or anxious, you try to treat. The concept of collaborative care between psychiatrists and family doctors, which is much in the news of late, started about 30 years ago in England and was imported into the United States during the 1990s, notably by Wayne Katon, M.D., of the University of Washington, and his colleagues (Psychiatric News, March 6, 2009; January 18). Katon s work is extremely important to our field, Mary Jane Massie, M.D., see Psychosomatic on page 28

19 14 PSYCHIATRIC NEWS APRIL 5, 2013 PROFESSIONAL NEWS APA, Connecticut Psychiatrists Protest Insurer Practices APA and the Connecticut Psychiatric Society say Anthem s reimbursement policies are forcing psychiatrists to deny patients psychotherapy or provide it at no cost. BY MARK MORAN A PA, the Connecticut Psychiatric Society (CPS), and the Connecticut State Medical Society are protesting what they say are violations of federal and state parity laws by Anthem Blue Cross Blue Shield of Connecticut. In a joint letter last month to the company, the three associations said Anthem s implementation of new CPT codes increases the financial and time burden on patients who seek treatment from psychiatrists and discourages psychiatrists from providing psychotherapy. They maintained that Anthem is violating the Mental Health Parity and Addiction Equity Act, the Connecticut Parity Law, HIPAA, and the Unfair Insurance and Unfair Trade Practices laws as they pertain to the treatment of patients with a mental or substance use disorder. Specifically, the groups said Anthem has responded to recent changes in CPT codes for psychiatry by covering only patient visits that are to be reported for medical evaluation and management while not covering psychotherapy as a separate and equal payment category. In addition, they stated that there is a significant disparity between reimbursement rates Anthem is paying to psychiatrists and those paid to other medical/ surgical network providers. Noting that beneficiaries pay for Gender Dysphoria continued from page 9 or an insistence that he or she is the other gender... ) is now necessary but not sufficient to meet the diagnosis, which makes the diagnosis more restrictive and conservative. It s really a narrowing of the criteria because you have to want the diagnosis, Drescher said. It takes psychiatrists out of the business of labeling children or others simply because they show genderatypical behavior. PN A fact sheet on gender dysphoria is posted at Anthem coverage with the understanding that they will have equal coverage for psychiatric services, CPS Executive Director Jacqueline Coleman said in a statement, We will not allow insurance companies to deny coverage that patients and their employers have paid for, nor will we ask psychiatrists to provide medically necessary psychotherapy for free to insured patients. The challenge presented by Anthem appears to be part of what may be a widening confrontation over the interpretation of the mental health parity law. In New York, the New York State Psychiatric Association is lead plaintiff in a class-action suit against UnitedHealth Group for alleged paritylaw violations (see page 1). Regarding Anthem s practices in Connecticut, APA Medical Director James H. Scully Jr., M.D., said, These practices are Lawsuit continued from page 1 national associations have fought for years for parity legislation, and we were mostly successful, Martin told Psychiatric News. That was only the first step, and now we find that we have to fight for full implementation of the laws and regulations. This lawsuit allows us to go on the offensive in this struggle, and we are confident we will prevail to the benefit of our patients and colleagues. A 100-plus-page formal complaint details the violations alleged by NYSPA and individual beneficiaries. These include numerous member complaints about United s restrictions on psychotherapy. NYSPA members have reported United fully curtailing psychotherapy for patients requiring long-term treatment, allowing no more than weekly psychotherapy for patients who have attempted suicide and been hospitalized (in one case a patient attempted suicide five times and was hospitalized 10 times), and refusing to cover more than one weekly session of psychotherapy for actively suicidal patients, according to the complaint. The document states that NYSPA members have also complained about United beneficiaries reporting extreme difficulty obtaining initial and continuing authorizations for intermediate levels of care, such as intensive outpatient treatment and partial hospitalization for mental health and substance abuse disorders. both unethical and illegal. We worked very hard to enact mental health parity laws, and it is now clear that Anthem is seeking a way to avoid compliance. We are not prepared to allow Anthem to skirt its obligations under the law. In the letter, the three groups say that by not accepting a separate billing code for psychotherapy, Anthem is forcing psychiatrists to face the choice of denying patients a critical part of their treatment, encouraging them to seek it from a No other medical specialty is being asked to deny crucial treatment for patients in need or to provide those treatments without payment from the insurer. different provider at additional cost and effort, or providing it at no cost. No other medical specialty is being asked to deny crucial treatment for patients in need or to provide those treatments without payment from the insurer, Scully added. Matthew Katz, executive vice president and CEO of the Connecticut State Medical Society, agreed. Mental health parity is more than just words it is a commitment to equality and fairness in the provision of quality mental, behavioral, and substance abuse health care services, he said in a statement. Coming at a time when our state is still recovering from the Newtown tragedy, it is more important than ever that those who need psychiatric services receive them, without discrimination or stigma. It is time for Anthem to act appropriately and honor its obligation to ensure access to mental and behavioral health services for the patients it insures. Studies have shown that when people who need psychiatric services receive them, they have fewer general health problems and, in the long run, have fewer health care costs than those who have no treatment, said Scully. PN The letter to Anthem BCBS is posted at Advocacy%20and%20Newsroom/Press%20 Releases/2013%20Releases/13-14-Anthem- Blue-Cross.pdf. Additionally, NYSPA alleges a pattern of denying coverage for out-of-network mental health services due to purported failures by providers to respond to requests for back-up clinical information when in fact no such requests have been made. This is not an isolated incident, according to the complaint. In each of the cases, UBH or OptumHealth asserts either in writing or over the telephone that it has repeatedly contacted either the beneficiary or the provider to obtain additional information regarding out-ofnetwork claims, yet none of the parties report receiving any such requests for information. As a result of the alleged failure to respond to requests for information, the patient s out-of-network claims are then denied. Additionally, the suit cites numerous complaints alleged by three individual beneficiaries. These include a detailed history of problems associated with obtaining treatment or reimbursement for treatment of a child with ADHD, bipolar disorder, delusions and hallucinations, and a history of suicidal ideation and homicidal threats. Meiram Bendat, J.D., an attorney and psychotherapist who founded the mental health insurance advocacy service Psych- Appeal, told Psychiatric News that United s violations are systematic and pervasive. United has devised multilayered strategies in which it violates parity with respect to medical necessity and levelof-care guidelines for mental health and substance abuse and deprive patients and providers meaningful due process required by the Affordable Care Act, he said. Bendat is counsel for the plaintiffs along with the New York law firm Pomerantz Grossman Hufford Dalhstrom and Gross. At press time, a spokesperson for United told Psychiatric News that the company was reviewing the complaint and had no comment at the time. Colleen Coyle, J.D., general counsel for APA, said that the lawsuit is the beginning of a public battle to enforce parity laws. Unfortunately, what the plaintiffs complain about insurer manipulation of nonquantitative treatment limitations, CPT code changes, provider reimbursement rates, and documentation requirements in order to deprive mental health patients of the benefits for which they have paid is not unique to United or to New York, she told Psychiatric News. APA has been working with psychiatric patients, attorneys and members on these issues and on this case and others that have been filed and will be filed in the near future in an effort to compel carriers to stop what we believe are flagrant violations of the law and abuse of mental health patients and psychiatrists. PN The class action complaint is posted at Complaint.pdf.

20 GOVERNMENT NEWS 15 Scully, Other Experts Offer Fixes For Broken MH System Mental health leaders stress that the government must act now to get parity moving and funding boosted if more Americans are to access the care they need. BY JUN YAN The push to improve mental health policy in the United States is facing multiple obstacles on Capitol Hill, despite the recent clamor about the need for new mental health legislation in the wake of gun-law debates, members of a panel organized by Politico newspaper agreed in a public discussion March 5 in Washington, D.C. The panel consisted of James H. Scully Jr., M.D., APA medical director and CEO; C. Edward Coffey, M.D., CEO of behavioral health services at Henry Ford Health System; Philip Wang, M.D., deputy director of the National Institute of Mental Health (NIMH); and two members of Congress, Rep. Jim McDermott (D-Wash.) and Rep. Phil Roe (R-Tenn.), who were practicing physicians before being elected. McDermott is Congress s only psychiatrist. Recent high-profile shooting incidents, particularly the Newtown school massacre, again brought mental health issues to the forefront of political debate, reigniting pushes for health care policies that foster increased access to care. When asked about the likelihood of any new mental health legislation being passed by Congress in 2013, McDermott, who is a member on the House Ways and Means Subcommittee on Health, said he was pessimistic. Roe, chair of the House Education and Workforce Subcommittee on Health, Employment, Labor and Pensions, expressed his concern that linking mental health issues directly to gun violence, as some advocates and members of Congress are doing, can worsen the stigma attached to mental illness and leave people with untreated mental illness less likely to seek care. [Mentally ill patients] currently wait on average about two years after experiencing symptoms before they get treatment, Wang pointed out. NIMH is exploring ways to decrease the time to get patients, especially those with early psychosis, into effective treatment. Getting patients into treatment faster, however, requires a mental health care system that is far reaching and easily accessible. The [care] delivery system is failing in this country, said Coffey, who runs an integrated mental health program within Michigan s Henry Ford Health System that APA Medical Director James H. Scully Jr., M.D., was part of a panel last month to address ways to improve the U.S. mental health system. Also participating were Rep. Jim McDermott (left) and Philip Wang, M.D., of the National Institute of Mental Health. he said has dramatically reduced the suicide rate in the past decade to near zero. [The current system] is chaotic, it s inefficient, it s not integrated, it s not as good as it could be,... and it costs more than it needs to, he stressed. We need a total redesign of the health care system. Access to quality mental health care continues to be hampered by inadequate funding. We have been, socially, squeezing the money out of the system since the 1970s, McDermott stated. Scully emphasized that it s time for a presidential commission to solve the systematic Don t Cut Drug-Abuse Research, Experts Tell Hill Staffers Congressional staff hear why National Institute on Drug Abuse grantees must be allowed to continue research on substance abuse service delivery to veterans. BY AARON LEVIN C ongress must continue to support National Institutes of Health (NIH) research efforts to improve effective treatments, ease dissemination, and use technology to help military personnel and their families deal with substance abuse in the aftermath of the conflicts in Iraq and Afghanistan, researchers and health officials told congressional staff at a briefing in Washington, D.C., March 12. The Capitol Hill briefing was organized by the Friends of the National Institute on Drug Abuse. APA was a cosponsor. Many of our returning service members have multiple problems, but pain is number one, said Michael Kilpatrick, M.D., deputy director of force health protection and readiness programs for the Office of the Deputy Assistant Secretary of Defense for Force Health Protection and Readiness. We have to take care of that first, without leading them toward addiction. Better battlefield medicine has helped more troops survive serious injury, but that also means that more live with chronic physical pain and consequent prescription of muscle relaxers, sedatives, and opiate pain relievers, with attendant potential for abuse, pointed out Wilson Compton, M.D., M.P.E., director of the Division of Epidemiology, Services, and Prevention Research at the National Institute on Drug Abuse (NIDA). There has been an especially marked increase in the misuse of prescription drugs since 2002, he said. Chronic pain increases the risk of mental health disorders, including substance abuse disorders. Jun Yan and long-entrenched problems hampering the mental health care system. Nearly five years after the mental health parity law was passed, the insurance industry is still dragging its feet implementing it, due largely to the government s delay in passing relevant regulations to guide implementation of the law s provisions, the panelists agreed. When available, insurance coverage for mental health care is usually not on a par with that for other illness categories. It pays so low that it costs you money to see a patient, which is why many practitioners do not take insurance, Scully commented. Both Scully and Coffey agreed that it is long overdue for mental health care to be integrated back into the rest of medicine. We have the mental health care we are paying for, Scully said. Without a substantial increase in funding, effective treatment and important knowledge about mental illness cannot get to Americans who need this care. The Politico event was supported by funding from Shire Pharmaceuticals, the maker of several drugs to treat attentiondeficit/hyperactivity disorder. PN A video of the Politico panel discussion can be accessed at www. politico.com/events/pro-deepdive-mental-health-policyand-the-113th-congress/index. html or by scanning the QR code. There has been a marked increase in the misuse of prescription drugs among U.S. troops, Wilson Compton, M.D., M.P.E., tells congressional staffers. Furthermore, mild traumatic brain injury (mtbi), even without a concussion diagnosis, affects the orbitofrontal cortex, which is also implicated in the onset and progression of addictions, said Compton. Rates of illicit substance use in military populations are low because of longstanding zero-tolerance policies, but see Drug Abuse on page 18 Aaron Levin