CMS National Coverage Determination Update

Produced by Kaiser Foundation Health Plan of the Mid-Atlantic States, Inc., networkwith the Mid-Atlantic Permanente Medical Group, P.C. Website: providers.kaiserpermanente.org/mas news

NOVEMBER 2014

FOR PRACTITIONERS & PROVIDERS OF KAISER PERMANENTE CMS National Coverage Determination update Decision memo for Transcatheter Mitral Valve Repair (TMVR) Transcatheter Mitral Valve Repair (TMVR) The Centers for Medicare & Medicaid Services (CMS) covers transcatheter mitral valve repair (TMVR) under Coverage with Evidence Development (CED) with the following conditions: TMVR is covered for the treatment of significant symptomatic degenerative mitral regurgitation when furnished according to an FDA approved indication and when all of the following conditions are met. • The procedure is furnished with a complete transcatheter mitral valve repair system that has received FDA premarket approval (PMA) for that system’s FDA approved indication. • Both a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease have independently examined the patient face-to-face and evaluated the patient’s suitability for mitral valve surgery and determination of prohibitive risk; and both physicians have documented the rationale for their clinical judgment and the rationale is available to the heart team. • The patient (preoperatively and postoperatively) is under the care of a heart team: a cohesive, multi-disciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient-centered care.

For additional information, please visit cms.gov/medicare-coverage-database/ details/nca-decision-memo.aspx?NCAId=273

Clinical practice guideline Medical Coverage Policies 2 updates 6 update III 10 New technology Pharmaceutical management Rescheduling of Tramadol and Diagnosis documentation for Information and updates Hydrocodone combination 4 coding heart arrhythmia’s 7 13 products (HCPs) Documentation of Distribution errors can have coordination of care with Provider and practitioner serious consequences primary care physicians (PCPs) satisfaction survey 5 8 — 2 — 14 Decision memo for invalidation of national coverage Administration (FDA) approved/cleared laboratory determination 140.3 - Transsexual surgery tests, used consistent with FDA approved labeling Department of Health and Human Services and in compliance with the Clinical Laboratory Departmental Appeals Board (DAB) has invalidated Improvement Act (CLIA) regulations, when ordered National Coverage Determination (NCD) 140.3 by the beneficiary’s primary care physician or “Transsexual Surgery”. As a consequence of practitioner within the context of a primary care this decision, NCD 140.3 is no longer valid. setting, and performed by an eligible Medicare Implementation of this policy shall be June 29, provider for these services, for beneficiaries who 2014. In the absence of an NCD, MA and Cost meet either of the following conditions. plans such as KP, should consider whether any • A screening test is covered for adults at high Medicare claims for these services are reasonable risk for Hepatitis C Virus infection. “High risk” is and necessary under §1862(a)(1)(A) of the SSA defined as persons with a current or past history consistent with the existing guidance for making of illicit injection drug use; and persons who such decisions when there is no NCD. have a history of receiving a blood transfusion prior to 1992. Repeat screening for high risk For additional information, please visit cms.gov/ persons is covered annually only for persons Regulations-and-Guidance/Guidance/Transmittals/ who have had continued illicit injection drug use Downloads/R169NCD.pdf since the prior negative screening test. • A single screening test is covered for adults who Decision memo for screening for Hepatitis C do not meet the high risk as defined above, but Virus (HCV) in adults who were born from 1945 through 1965. The determination of “high risk for HCV” is identified The Centers for Medicare & Medicaid Services by the primary care physician or practitioner who (CMS) has determined the following: assesses the patient’s history, which is part of The evidence is adequate to conclude that screening any complete medical history, typically part of for Hepatitis C Virus (HCV), consistent with the grade an annual wellness visit and considered in the B recommendations by the U.S. Preventive Services development of a comprehensive prevention Task Force (USPSTF), is reasonable and necessary plan. The medical record should be a reflection for the prevention or early detection of an illness or of the service provided. disability and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B, as For additional information, please visit cms.gov/ described below. medicare-coverage-database/details/nca-decision- memo.aspx?NCAId=272 Therefore, CMS will cover screening for HCV with the appropriate U.S. Food and Drug

— 2 — Clinical practice guideline updates Clinical practice guidelines are systematically Child/adolescent attention-deficit/hyperactivity designed tools to assist participating practitioners disorder (March 2014) and patient decisions regarding specific medical No changes from the prior guideline. conditions and preventive care. Guidelines are informational and are not intended or designed Dyslipidemia treatment (March 2014) as a substitute for the reasonable exercise of independent clinical judgment by participating Guideline was revised to adopt the AHA/ACC practitioners in any particular set of circumstances recommendations for the treatment of blood for each patient. cholesterol. Coronary artery disease secondary prevention KPMAS has adopted and implemented the (May 2014) evidence-based Clinical Practice Guidelines developed by the Care Management Institute in Revisions conjunction with Permanente physician-experts • Incorporation of the JNC 8 Hypertension from across the KP program. These guidelines recommendations. cover preventive, acute, and chronic care. • Incorporation of the AHA/ACC cholesterol Preventive care guidelines include, but not limited treatment recommendations. to, breast, cervical, and colorectal cancer screening, • Incorporation of the USPSTF Aspirin immunizations, and obesity. Clinical practice recommendations. guidelines address the primary care management of common diagnoses, such as adult and pediatric Tobacco cessation (May 2014) asthma, diabetes mellitus, hypertension, attention New guideline to support tobacco screening, deficit hyperactivity disorder, coronary artery counseling, and medication. disease, and adult depression. Diagnosis and treatment of depression in adults The following clinical practice guidelines have been (June 2014) approved throughout this year and are available Revisions on the MAPMG online Web site. These guidelines • PHQ9 or PHQ2 screening tool is recommended apply to members in our commercial, Medicare, for all populations, including pregnant women Maryland Medicaid, Virginia Medicaid, and and older adults and replaces the Edinburgh Marketplace products. Postpartum depression scale and Geriatric Depression Scale, respectively. Adult diabetes (May 2014) • Removed recommendation for St. John’s wort as Revisions a first line treatment. • Incorporation of the JNC 8 Hypertension • Updated language to reflect DSM-5 diagnoses recommendations. related to dysthymia (now persistent depressive • Incorporation of the AHA/ACC cholesterol disorder) as it relates to long-term treatment, treatment recommendations. monitoring, and follow up for patients with • Incorporation of the USPSTF Aspirin double MDD. recommendations. Adult hypertension (August 2014) Heart failure (January 2014) Guideline was revised to adopt the NHLBI JNC 8 No changes from the prior guideline. Hypertension evidence review recommendations.

— 3 — Preventive care services for adults and older Guideline. If you need assistance with your site adults (October 2014) registration, please e-mail [email protected] or No changes from the prior guideline. call Lee at (301) 816-6309.

To read the guidelines, login at https://www. Several other clinical practice guidelines may be mapmgonline.com/portal. Select ‘Guidelines’ found at the above Web site. If you would like to under the “Group Navigation” drop down list and receive a hard copy of these or any other Clinical locate the appropriate topic and Clinical Practice Practice Guideline, please contact the Provider Relations Department at 1-877-806-7470. Diagnosis documentation for coding heart arrhythmia’s All heart arrhythmias are considered non-systemic 427.1 Paroxysmal Ventricular Tachycardia conditions which require documentation to support A tachyarrhythmia that originates from an ectopic the consideration/evaluation of the condition site in a ventricle and is characterized by sudden in the progress note. Examples of supporting onset and abrupt termination. documentation in the provider’s progress note to support coding the diagnosis: 427.2 Unspecified Paroxysmal Tachycardia

427.31 Atrial Fibrillation Dx: Paroxysmal Irregular rapid atrial contractions exceeding 400 Dx: Atrial Atrial Tachycardia beats per minute. The ventricular response is also Fibrillation Note: patient irregular and variable (“irregularly irregular”). AF is Note: patient given Verapamil 5 the most common sustained arrhythmia in adults. taking Coumadin mg IV over 5 min 427.32 Atrial Flutter” Regular rapid atrial contractions. Cardiac Dysrhythmias, disturbances in cardiac rate and rhythm, including abnormalities in the rate, 427.81 Sinoatrial node dysfunction regularity, and sequence of atrial and /or ventricular A complex arrhythmia that can appear as contractions. They may be benign or malignant severe sinus bradycardia, sinus bradycardia and can take many forms; the clinical significance with tachycardia, or sinus bradycardia with of each depends on the extent to which they lower atrioventricular block (“Sick sinus syndrome”). blood pressure and reduce cardiac output with resulting hypoperfusion of vital organs.

Below are a few of the more commonly diagnosed Diagnosis coding tips arrhythmias: • Providers should follow ICD-9 CM 427.0 Paroxysmal Supraventricular guidelines when coding all diagnoses. Tachycardia (SVT) • Providers should code all documented A group of tachyarrhythmia’s that originate from conditions that co-exist at the time of the within or above the atrioventricular (AV) node and encounter that require: are characterized by sudden onset and abrupt * Patient care termination. The most common types include * Treatment AV nodal reentrant tachycardia (AVNRT), AV * Management reentrant tachycardia (AVRT), and paroxysmal atrial • Do not code conditions that were tachycardia (PAT). previously treated and no longer exist.

— 4 — Distribution errors can have serious consequences Every day we use email, for both business reasons Under HIPAA, whenever PHI is sent or handed and personal use. It’s become such a part of our to the wrong individual, it is considered an regular routine that we don’t give it much thought. impermissible disclosure. Besides the email errors described above, other examples of impermissible But when we stop paying attention we can make disclosures include: mistakes, and some mistakes can have serious consequences. • handing a membership card, a prescription, After Visit Summary, pre-op instructions, or For example, email systems will sometimes discharge instructions to the wrong individual automatically populate the “To” field after you • faxing to the wrong number type in just a few letters. Have you ever hit “Send” • mailing information intended for two different only to realize you just sent something to a perfect individuals in one envelope stranger – or an entire distribution list of strangers? • mailing information to the wrong address (if it is If the contents are sensitive or private – or contain opened) Protected Health Information (PHI), this is more • leaving a detailed message on the wrong than an “oops” moment. patient’s answering machine • sending patient secure messages to the wrong When you forward or reply to an email that contains patient, or when it contains another patient’s PHI, always consider whether or not the recipients information need that information to do their job. If not, consider creating a new message that only contains If you are responsible for or become aware of a the information needed by the recipients, or if you distribution error, report it to your manager or forward or reply to an email with an attachment that compliance officer immediately so they can begin contains PHI, delete the attachment before sending to investigate and address the incident. the response if the recipients do not need that information to do their job. Think about all of the resources involved in investigating and correcting this one mistake – and Should you need to send anything sensitive, look think before you act. Taking a few extra seconds to to send the information encrypted. But encryption review the information you are sending or handing is no magic bullet. Encryption protects the over to patients, and/or reviewing your email information in transit, but if you send the email to distribution list prior to hitting send, can prevent the wrong recipient, that recipient will still be able distribution errors. to decrypt it.

— 5 — Medical Coverage Policies update III November 2014 Medical Coverage Policies (MCPs) are developed • Breast reduction for gynecomastia: No in collaboration with specialty service chiefs and change in coverage. Indicated when breast clinical subject matter experts. MCPs specify reduction surgery is intended to significantly clinical criteria supported by current peer reviewed improve physical function; cosmetic breast literature and are intended to guide use of reduction is not covered. Patients must be health care services such as devices, drugs, and one year postpartum and have stopped breast procedures. The policies are reviewed and updated feeding for at least 6 months prior to referral. annually, reviewed for approval by the Regional Unilateral and male mammoplasties are not Utilization Management Committee (RUMC), and covered except as reconstruction surgeries for filed with the Maryland Insurance Administration. diagnosis of breast cancer. These MCPs are usually applicable only to commercial members, except where noted. • Circumcision: Indications for routine and non-routine circumcision for children (after New policy the first seven days after birth) includes NICU Insulin Infusion Pumps: Defines criteria for coverage admission, and other medical reasons indicated of external (non implanted) insulin infusion pumps, in the medical coverage policy. Circumcision is supplies, and insulin refills for patients with diabetes also covered for adopted males within one year Type 1 or Type 2 complications, and women with of adoption. diabetes who are preconception or pregnant, to reduce the incidence of fetal mortality or anomaly. Revision of circumcision is indicated for lysis or excision of penile post circumcision adhesions Reviewed and revised policies which have resulted in preputial bridges or post circumcision phimosis. Referral for revision should Bariatric Surgery for DC, Virginia, and Federal be made after a trial of topical steroid therapy. Employee Members: Criteria changed for initial surgery; requires BMI > 40 or BMI >35 (with one • Cochlear implant: No change in coverage. or more comorbid conditions) for at least one year For adults, >18 years of age or older, the (instead of two years) for patients aged 18 or more. patient must have bilateral severe to profound sensorineural hearing loss (SNHL). Most patients • Bariatric surgery for Maryland members: No must have obtained “limited benefit” from a change in coverage. Indicated Initial surgery trial of appropriately-fitted binaural hearing aids. requires BMI > 40 or BMI >35 with one or more For children, if there is a diagnosis of cochlear comorbid conditions for patients aged 18 or ossification, the requirement for a hearing aid more. trial may be waived — 6 — • Compression garments: Clinical indications • Vitiligo: No change in coverage. For diagnosis for bandage wraps and compression garments of Vitiligo, intent of treatment is to prevent sun include treatment of lymphedema, including damage to skin and decrease susceptibility of primary edema and secondary edema affected skin to skin cancer.

Indications for pneumatic compression devices For Network physicians, access to MCPs is only can be found in the Medicare Coverage Database, two clicks away in Health Connect Affiliate Link which remains the coverage criteria source for Provider Portal located at providers.kp.org/mas. pneumatic devices for both commercial and Contracted physicians with access to our provider Medicare members. portal can view our MCPs, and their patients’ benefits and medical record. To obtain access, go • Continuous glucose monitors: Indicated to the same web address and click the Forms tab. for adults with Diabetes types 1 and 2 and After completing the enrollment packet, fax to for children (under the age of 18) with type 1 301.388.1695. Access usually takes 5-7 days after diabetes. Adult criteria requires failure of a 3-7 enrollment forms are received. day diagnostic continuous glucose monitoring to reconcile hypoglycemia and subsequent treatment After access to Health Connect Affiliate Link has plan change. For children with type 1 diabetes, been obtained, click on the Clinical Library section they must have a hypoglycemic complication, be on the right side of the KPHC Home page and using an insulin pump or have a multiple daily shot then type in medical coverage policies in the schedule of three or more shots daily. All devices search box. All medical coverage policies will be must be ordered and managed by the appropriate displayed. endocrinology specialist. If you would like to receive a hard copy of the • Varicose Veins: No change in coverage. Criteria Medical Coverage Policy, please contact the requires a diagnosis of venous insufficiency with Utilization Management Operations Center varicose veins and one or more of the following: (UMOC) at 1-800-810-4766 and follow the prompts. leg ulcerations associated with saphenous vein insufficiency, recurrent bleeding from the If you have questions please feel free to contact: saphenous vein or other varicosities; history Claudia Donovan M.D. of a single, significant episode of bleeding; Physician Referral Manager or symptomatic enlarged varicose veins [email protected] unresponsive to compression stockings after 3 or more months. Pharmaceutical management information and updates The KPMAS Regional Pharmacy & Therapeutics with additions and/or deletions approved by the (P&T) Committee approves drug formularies for all Regional P&T Committee. For the most recent lines of business. The Regional P&T Committee, information on drug formulary updates or changes, with expert guidance from various medical please reference the broadcast email distributed specialties, evaluates, appraises, and selects from by the Regional P&T Committee co-chairs, the available medications those considered to be the quarterly “Tips on Scripts” Newsletter (MAPMG most appropriate for patient care and general use practitioners) and/or the online Community within the region. The purpose of the formulary Provider Portal (CPP for affiliated practitioners) is to promote rational, safe, and cost-effective available at providers.kaiserpermanente.org/html/ drug use and the formulary is updated monthly cpp_mas/formulary.html.

— 7 — Provider access to health education materials KP physicians and network providers have access to programs, providers can: all health education materials to provide to patients • Refer or direct book members into health as part of After Visit Summary or to supplement education programs through eConsult system discussion from patient visit. • Provide members with information on how to self-register through KP HealthConect After Visit MAPMG and Network providers can view materials Summary or hard copy flyers through a centralized internal “clinical library” with electronic inventory of health education materials Additional information on health education that can be used for all visit types. Health education programs, tools, and resources is available by: content is also embedded into KP HealthConnect • Visiting kp.org/healthyliving for inclusion in member After Visit Summary or • Contacting the Health Education automated line sent via secure messaging. For health education (301) 816-6565 or 1-800-444-6696 (toll free) Documentation of coordination of care with primary care physicians (PCPs) Kaiser Permanente continues to be a leader in If you are not sure how to contact the member’s promoting the integration of behavioral and PCP, you may mail or fax treatment information to medical health care and views care coordination the following address and we will make sure the between Behavioral Health and Primary Care to be PCP gets your report: a critical aspect of treatment. Kaiser Permanente Behavioral Health providers are asked to obtain the Regional HIMS member’s consent to communicate the following 6526 Belcrest Road, Suite 207 to the patient’s PCP within seven (7) days of the Hyattsville, Maryland 20782 beginning of treatment: Fax: (301) 209-6065 • Date of initial service • Patient’s diagnosis and brief assessment of their findings • Treatment plan and recommendations • Medications prescribed

— 8 — Medical record documentation standards Medical record documentation standards are based 7. Past surgical history is documented or noted as on and adopted from several risk management “none” on the problem list or face sheet. and quality improvement sources. Medical record 8. Family history is documented or noted as documentation is required to report pertinent facts, “none” on the problem list or face sheet. findings, and observations about an individual’s physical or mental health history (including present 9. For patients 14 years and older, there is illnesses and/or chronic conditions and past documentation of the following in either the medical, surgical and social histories), examinations, progress note or face sheet. tests, treatments, and outcomes. a. Alcohol use or lack thereof b. Substance use or lack thereof The medical record chronologically documents the care of the patient and is an important element c. Tobacco use or lack thereof contributing to high quality care. Payers have d. Sexual behavior a contractual obligation to enrollees and may 10. There is a chief complaint documented for each require reasonable documentation that services are encounter visit. consistent with coverage provided. 11. There is a history of present illness documented for each encounter visit. Validation may include the following information: • Location of service. 12. There is an examination documented in the • Medical necessity and appropriateness of progress note relevant to the chief complaint. diagnostic and/or therapeutic 13. There is a treatment plan documented for each services. encounter visit. • Services provided have been correctly coded 14. Follow-up instructions are documented in the and reported based on supporting encounter and include follow-up instructions documentation in the medical record. and time frame for follow-up. Kaiser Permanente of Mid-Atlantic States 15. For laboratory orders written during the has adopted the following medical record encounter, the results indicate signature and documentation standards. date of ordering provider’s review. 16. Radiology orders written during the encounter 1. All entries are legible. being reviewed, the results indicate signature 2. All entries are authenticated by the author with and date of ordering provider’s review. signature, credentials and date of entry. 17. If a referral or order for services (procedure 3. Medication allergies and adverse reactions or diagnostic testing-internal or external) are prominently listed or noted as “none” or is requested during the encounter being “NKA.” reviewed, there is a written report or results from the consultant/provider in the record. 4. There is an immunization summary for patients 18 years and younger. 18. If a consultation is requested, there is a written summary report reflecting the practitioner 5. There is a problem list with significant illnesses review with date of review and signature. and conditions listed in the medical record. 19. Abbreviations used within the encounter are 6. Chronic conditions and significant illnesses are listed on the approved “Abbreviation List” listed. located in the physician’s office.

— 9 — New technology Gregory Alexander, M.D., F.A.A.F.P non-randomized) between cryoablation and RF Physician Director, Referrals and Medical Policies ablation reporting similar rates of freedom from AF, re-ablation, and complications at one year The Kaiser Permanente Interregional New follow-up. Recent large single arm studies report Technologies Committee (INTC) met and reviewed similar outcomes at one year and some studies new and emerging technologies that are pertinent indicate there may be improved efficiencies with to the Kaiser Permanente Mid-Atlantic States cryoablation over RF ablation. Proper training, (KPMAS) delivery system. The new technologies the development of a protocol for appropriate listed below were reviewed and approved by the patient selection, and use at high-volume local Technology Review and Implementation centers of excellence are important. Longer-term Committee (TRIC). The following is a brief synopsis data is needed. An internal IRB approved study that summarizes New Technology: Summary of New is ongoing to monitor outcomes and evaluate Technology conclusion regarding the reviews. possible efficiencies.

Cryoablation for atrial fibrillation KPMAS coverage position INTC brief synopsis • Referrals for Cryoablation for Atrial Fibrillation • There is insufficient evidence to determine will be reviewed on a case by case basis. whether cryoablation is a medically appropriate There are certain patient selection criteria treatment option for patients with atrial that favor Cryoablation over other modalities. fibrillation. The existing evidence regarding how Each external referral for Cryoablation of Atrial the technology effectively treats atrial fibrillation Fibrillation will be reviewed by the Cardiology is of insufficient quantity and quality. Service Chief and MAPMG EPS Specialist. • Members of the INTC acknowledge there is diffused use of cryoablation for treatment The continuous glucose monitor and insulin of paroxysmal atrial fibrillation in the pump with low suspend feature for diabetes community and within KP and will continue INTC brief synopsis to monitor internal results, long-term results, • There is insufficient evidence to determine and results from ongoing clinical trials. The whether the integration of a continuous glucose body of evidence currently consists of 3 monitor with an insulin pump with low suspend small comparative trials (1 randomized, 2 feature is medically appropriate for any patient

— 10 — with diabetes. The existing evidence is of ultrasound-guided radiofrequency thermal insufficient quality and quantity. A single trial ablation (RFVTA) is medically appropriate for any including 247 patients has reported 3 month patient with symptomatic uterine fibroids. The results of its use in a home setting. Although existing evidence is of insufficient quality and the trial results are generally favorable (reduced quantity. frequency and overall burden of hypoglycemia), • The current evidence base consists of a total the study has limitations and long-term studies of 3 single-arm prospective studies involving are needed to determine the effects on 202 patients diagnosed with symptomatic long-term glucose control and improved health uterine fibroids and treated with laparoscopic outcomes. ultrasound-guided RFVTA. These small studies suggest significant concerns regarding safety KPMAS coverage position and there is currently little evidence to evaluate • We will cover Continuous Glucose Monitors and the technology in women desiring future Insulin Pumps with Low Suspend Feature, that childbearing. are FDA approved for adults for the treatment of Diabetes, on a case by case basis as determined KPMAS coverage position by the patient’s Endocrinologist. • We agree with the Committee. KPMAS will not cover Radiofrequency Volumetric Thermal Testing ROS-1 and BRAF mutations for lung Ablation (RFVTA) for symptomatic uterine cancer fibroids given the concerns about safety and the INTC brief synopsis lack of evaluation of the technology in women • There is insufficient evidence to determine desiring future childbirth. that BRAF or ROS1 testing is medically appropriate for any patient with lung cancer. Bronchial Thermoplasty (BT) for the treatment of The existing evidence is of insufficient quantity moderate and/or severe persistent asthma and quality. Clinical validity studies included INTC brief synopsis small numbers of patients with mutations and • There is insufficient evidence to determine outcome results were not consistent. Abstracts whether bronchial thermoplasty (BT) is a for preliminary phase I and II trials appear medically appropriate treatment option for promising but additional research is needed adults with moderate or severe persistent to establish clinical utility and improvement in asthma refractory to standard treatment. The health outcomes. Several trials are underway existing evidence is of insufficient quantity and but peer-reviewed published results are not quality. expected until 2015 or later. • Randomized controlled trials involving 434 patients reported improvement in mild and KPMAS coverage position severe exacerbations, quality of life, and asthma • Genetic testing for lung cancer is evolving. We symptoms when compared to usual care or will cover this testing when it is considered sham treatment; however, there appears to be a clinically appropriate by the treating Oncologist significant increase in the risk of hospitalization and Pathologist. and adverse respiratory events when initially treated. Five year trial data has recently been Laparoscopic Ultrasound-Guided Radiofrequency published and control group data is lacking. Volumetric Thermal Ablation (RFVTA) using the The lack of control group results degrades the acessa system for symptomatic uterine fibroids study design and the ability to draw conclusions INTC brief synopsis about the data. Results suggest that, compared • There is insufficient evidence to determine to pre-treatment, there is a trend toward whether treatment using laparoscopic fewer hospitalizations and ED visits, as well

— 11 — as overall and severe adverse events over five and Primary Care Physicians discouraging years. No differences in quality of life, symptom the use of gastrostomy tubes in patients with control or measures of lung function were advanced dementia. observed in BT patients in comparisons of pre-treatment vs. 5-year follow-up data. Potential Platelet-rich plasma for tendinopathies candidates should be part of an IRB trial with a INTC brief synopsis well-designed protocol, appropriate informed • There is insufficient evidence to determine consent, and structured follow-up. whether platelet-rich plasma is medically appropriate as a nonsurgical or surgical KPMAS coverage position orthopedic treatment for any patient. The existing • There is insufficient evidence to cover Bronchial evidence is of insufficient quantity and quality. Thermoplasty (BT) for the Treatment of • Results from randomized controlled trials and Moderate and/or Severe Persistent Asthma controlled studies did not provide consistent except when considered for use within the or conclusive evidence that platelet-rich plasma context of a clinical trial. improves outcomes or accelerates healing in patients who have tendon or ligament injuries or Artificial feeding/gastrostomy tube placement in who undergo surgical procedures such as joint dementia patients replacement or tendon/ligament repair. INTC brief synopsis • There is sufficient evidence to determine KPMAS coverage position that gastrostomy is generally not medically • The evidence regarding the use of platelet-rich appropriate for any patient with advanced plasma for tendinopathies is insufficient to dementia. establish its safety and effectiveness. The use • Five comparative and 7 clinical series involving of platelet-rich plasma for tendinopathies is not over 40,000 patients have indicated feeding covered as it is considered experimental. tubes do not result in improved survival, prevention of aspiration pneumonia, or improved Automated hand hygiene monitoring systems healing of pressure ulcers. While the studies INTC brief synopsis are mainly retrospective in nature, feeding • There is insufficient evidence on automated tube use has been associated with increased hand hygiene monitoring (AHHM) as a hospitalization, pressure ulcer development, stand-alone method of decreasing nosocomial peritonitis, use of physical and pharmacological infection rates. restraints, and patient distress. • There is moderate quality evidence from a single industry sponsored RCT that an AHHM real-time KPMAS coverage position reminder and feedback system can lead to small • The placement or replacement of a feeding tube improvements in hand hygiene compliance; in a severely demented patient is an individual however, more research is needed to validate decision most often made by the patient’s these systems in other hospital settings and Attending Physician and family. However, the using other technology before they can be current literature has established that the use accepted as standard practice. of gastrostomy tubes is not generally medically appropriate in severely demented patients. KPMAS coverage position • Dr. Lya Karm, the Service Chief for the • The use of Automated Hand Hygiene Monitoring Continuing Care Department, and David Systems for decreasing nosocomial infections Harper, the Senior Manager of Hospice and has not been established as an effective Palliative Care, are embarking on an educational stand-alone intervention. campaign for the Hospitalists, SNF Rounders,

— 12 — Rescheduling of Tramadol and Hydrocodone combination products (HCPs) – what you need to know. The Federal Controlled Substance classification of Data from the National Survey on Drug Use and Tramadol and Hydrocodone combination products Health (NSDUH) indicate that the number of (HCPs) has recently changed with the goal of individuals who have used tramadol products decreasing diversion and increasing patient safety. non-medically at least once in their lifetime increased from 994,000 in 2002 to 2.6 million These scheduling reclassifications affect how each in 2011. In addition, the Drug Abuse Warning medication can be ordered, the number of refills Network (DAWN) reports that from 2004 to 2010, allowed and the expiration date for the order. the national annual estimates of emergency Please note that the KPMAS formulary status of department visits related to non-medical use or these products has not been affected by these abuse of tramadol-containing products increased changes. from 4,849 to 16,251.

Tramadol1 As of August 18, 2014, the following changes Tramadol is a centrally acting synthetic opioid occurred due to the rescheduling of tramadol: analgesic indicated for the relief of moderate-to- • A new signed hard copy prescription is required moderately-severe pain in adults. for all new prescriptions; • Prescriptions for tramadol may only be refilled Effective August 18, 2014, tramadol has been up to five times within six months after the issue reclassified as a Schedule IV Controlled Substance date; and under the Controlled Substance Act. This final • After five refills or after six months, whichever ruling was published in the Federal Register by the occurs first, a new signed prescription is Drug Enforcement Agency (DEA) on July 2, 2014. required.

2,3 Although the mechanism of action of tramadol is Hydrocodone not completely understood, available data indicate Hydrocodone is a semi-synthetic opioid most that the opioid-like activity of tramadol is primarily closely related to codeine in structure and due to the binding of the parent compound and morphine in opiate-like effects. Hydrocodone its active metabolite, O-desmethyltramadol to combination products (HCPs) are commonly used mu-opioid receptors. Most adverse effects of to treat cough or moderate to severe pain. tramadol, including respiratory depression and sedation, are due to its opioid activity. Tolerance Effective October 6, 2014, HCPs have been and dependence have been reported with a reclassified as Schedule II Controlled Substances withdrawal syndrome of similar intensity to other (previously Schedule III*) under the Controlled Schedule IV drugs such as pentazocine. Substances Act. This final ruling was published in the Federal Register by the DEA on August 22, 2014.

1 Schedules of Controlled Substances: Placement of Tramadol Into Schedule IV. 79 FR 37623. Pages: 37623-37639. Published: July 2, 2014. Available at: https://federalregister.gov/a/2014-15548 2 Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products From Schedule III to Schedule II. 79 FR 49661. Pages: 49661-49682. Published: August 22, 2014. Available at: https://federalregister.gov/a/2014-19922 3 Hydrocodone. Drug Enforcement Administration Office of Diversion Control. Available at: http://www.google.com/url?sa =t&rct=j&q=&esrc=s&frm=1&source=web&cd=11&cad=rja&uact=8&ved=0CB0QFjAAOAo&url=http%3A%2F%2Fwww. deadiversion.usdoj.gov%2Fdrug_chem_info%2Fhydrocodone.pdf&ei=JbI-VKjpMMioogSCy4HYDg&usg=AFQjCNEjAsiPcqY OMBqBrHDSPl_lDNOerQ * Single entity hydrocodone products have been Schedule II Controlled Substances since 1971.

— 13 — As with most opiates, abuse of hydrocodone is high The co-formulation of hydrocodone with and associated with tolerance, dependence, and acetaminophen carries an additional risk of liver addiction. The US American Association of Poison toxicity when high, acute doses are consumed. Control Centers (AAPCC) reports that in 2012, there were 29,391 total exposures and 36 deaths As of October 6, 2014, the following changes associated with hydrocodone. The NSDUH reports occurred due to the rescheduling of HCPs: that in 2013, 24.4 million people, aged 12 and older, • A new signed hard copy prescription is required used hydrocodone for nonmedical purposes in for every fill of HCPs; their lifetime, compared to 25.7 million in 2012 and • Prescriptions for HCPs can no longer be faxed or DAWN estimates 82,480 emergency department called in to pharmacies; visits were associated with nonmedical use of • No refills are allowed for HCPs; every request will hydrocodone in 2011 (a 107% increase from the require a new signed hard copy prescription; and number of ED visits reported in 2004 (39,846)). • Like all Schedule II Controlled Substances, mail order services are no longer provided for HCPs.

Provider and practitioner satisfaction survey The provider and practitioner satisfaction survey of our support to our network and community for network physicians and practitioners remains physicians. open. This survey addresses the Kaiser Permanente Referral and Utilization Management processes Survey links which affect you and your patients. The survey • Primary care physicians and practitioners: consists of two simple questions about your https://kp.qualtrics.com/SE/?SID=SV_ perception of these processes. ea3p7NUwSH5w4Qt • Specialty physicians and practitioners: The survey is open for your online completion. To https://kp.qualtrics.com/SE/?SID=SV_ access the survey, please use either an Internet eKf6HLGVzLhQ5lX Explorer or Chrome browser to access the appropriate link below to access the survey. Your These links also are available directly from the responses remain completely anonymous and are Community Provider Portal; go to the very valuable to Kaiser Permanente as a measure Provider Information/Newsletter tab. Keeping the provider directory up to date Please use the sample letter format on the next page to update us with any changes you may have through out the year. It is very important that we have the most accurate information when we pull our data for the directory.

Changes may be made by fax to: (301) 388-1700, If you would like to request a provider directory email [email protected], or by mail: please contact Member Services at: Kaiser Foundation Health Plan of • Within the Washington, D.C., metro area call The Mid-Atlantic States, Inc. (301) 468-6000, (301) 879-6380 TTY Provider Relations; Flr 2 East • All other areas outside of Washington, D.C., 2101 East Jefferson St. metro area call 1-877-777-7902, Rockville, MD 20852 1-800-700-4901 TTY

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Tax identification #: Requestor phone #: Effective date of change(s): Requestor:

Reason for the request:

•Address change (practice location or billing) *identify whether adding or deleting demographic change •Adding a provider or practitioner to an existing group contract *identify whether adding or deleting provider

If adding or deleting a provider please include:

• First and last name • Sex • Title or degree • NPI number • CAQH number • UPIN or social security number • Primary specialty with secondary specialty if applicable • Practice locations w/ phone and fax numbers • Foreign languages • If urgent care/ will the provider have a panel of Kaiser Permanente patients.

— 15 — Presorted Standard US Postage The Mid-Atlantic Permanente Medical Group, P.C. PAID 2101 E. Jefferson Street Rockville, MD Rockville, MD 20852 Permit # 4297