Outpatient Drug Services Handbook

Total Page:16

File Type:pdf, Size:1020Kb

Outpatient Drug Services Handbook Texas Medicaid Provider Procedures Manual November 2020 Provider Handbooks Outpatient Drug Services Handbook The Texas Medicaid & Healthcare Partnership (TMHP) is the claims administrator for Texas Medicaid under contract with the Texas Health and Human Services Commission. TEXAS MEDICAID PROVIDER PROCEDURES MANUAL: VOL. 2 NOVEMBER 2020 OUTPATIENT DRUG SERVICES HANDBOOK Table of Contents 1 General Information . 7 1.1 About the Vendor Drug Program. 7 1.2 Pharmacy Enrollment . 8 1.3 Program Contact Information. 8 2 Enrollment . 8 3 Services, Benefits, Limitations, and Prior Authorization. .8 3.1 Prior Authorization Requests . 9 3.2 Electronic Signatures in Prior Authorizations . 9 4 Reimbursement. .10 5 Injectable Medications as a Pharmacy Benefit. .11 6 National Drug Code (NDC) . .12 6.1 Calculating Billable HCPCS and NDC Units . .12 6.1.1 Single-Dose Vials Calculation Examples . 12 6.1.2 Multi-Dose Vials Calculation Examples . 13 6.1.3 Single and Multi-Use Vials . 13 6.1.4 Nonspecific, Unlisted, or Miscellaneous Procedure Codes . 14 7 Outpatient Drugs—Benefits and Limitations. .15 7.1 Abatacept (Orencia) . .15 7.1.1 Prior Authorization for Abatacept (Orencia) . 15 7.2 Adalimumab. .16 7.3 Ado-trastuzumab entansine (Kadcyla). .17 7.4 Alglucosidase Alfa (Myozyme) . .18 7.5 Amifostine . .18 7.6 Antibiotics and Steroids . .22 7.7 Antisense Oligonucleotides (eteplirsen, golodirsen, and nusinersen) . .22 7.7.1 Prior Authorization Requirements. 22 7.7.1.1 Initial Requests (for all Antisense Oligonucleotides) . 23 7.7.1.2 Recertification/Extension Requests (for all Antisense Oligonucleotides). 25 7.7.1.3 Exclusions . 25 7.8 Aripiprazole Lauroxil, (Aristada Initio). .26 7.9 Azacitidine (Vidaza) . .26 7.10 Blood Factor Products . .26 7.11 Botulinum Toxin Type A and Type B . .27 7.12 * Brexanolone (Zulresso) . .30 7.12.1 Risk Evaluation and Mitigation Strategy Program . 30 7.12.2 * Prior Authorization Requirements . 30 7.13 * Burosumab-Twza (Crysvita) . .31 2 CPT ONLY - COPYRIGHT 2019 AMERICAN MEDICAL ASSOCIATION. ALL RIGHTS RESERVED. OUTPATIENT DRUG SERVICES HANDBOOK NOVEMBER 2020 7.14 Calaspargase Pegol-Mknl. .32 7.15 Cemiplimab-rwlc. .32 7.16 Chelating Agents . .32 7.16.1 Dimercaprol. 32 7.16.2 Edetate calcium disodium . 33 7.16.3 * Deferoxamine mesylate (Desferal) . 33 7.17 Chimeric Antigen Receptor (CAR) T-Cell Therapy . .34 7.17.1 Prior Authorization Criteria for Axicabtagene Ciloleucel (Yescarta). 34 7.17.2 Prior Authorization Criteria for Tisagenlecleucel (Kymriah) . 35 7.17.3 Exclusions. 36 7.18 Clofarabine . .36 7.18.1 Prior Authorization for Clofarabine . 36 7.19 Colony Stimulating Factors (Filgrastim, Pegfilgrastim, and Sargramostim). .36 7.20 Crizanlizumab-tmca (Adakveo) . .40 7.20.1 Prior Authorization . 40 7.21 Denileukin diftitox (Ontak) . .41 7.22 Dimethyl sulfoxide . .41 7.23 Eculizumab . .41 7.24 Edaravone (Radicava) . .41 7.25 Emapalumab-lzsg (Gamifant) . .41 7.25.1 Prior Authorization Requirements. 41 7.26 Enfortumab Vedotin-ejfv (Padcev) . .42 7.27 Eravacycline (Xerava) . .42 7.28 Esketamine (Spravato) . .42 7.28.1 Prior Authorization . 43 7.29 Fam-trastuzumab Deruxtecan-nxki . .43 7.30 Fluocinolone Acetonide (Retisert) . .44 7.31 Fremanezumab-vfrm. ..
Recommended publications
  • Specialty Pipeline Monthly Update
    Specialty Pipeline Monthly Update Critical updates in an ever changing environment July 2018 New approvals ● Braftovi™ (encorafenib) + Mektovi® (binimetinib): Array BioPharma received U.S. Food and Drug Administration (FDA) approval for Braftovi and Mektovi, to be used in combination for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. The FDA also granted approval of the THxID BRAF Kit (bioMereieux) as a companion diagnostic for these therapeutics. The recommended doses are Mektovi 45 mg orally twice daily and Braftovi 450 mg orally once daily. ● Tibsovo (ivosidenib): Agios Pharmaceuticals received FDA approval for the treatment of relapsed or refractory acute myeloid leukemia (r/r/AML) with susceptible IDH1 mutation. Tibsovo is taken orally once daily until disease progression or unacceptable toxicity. It is estimated that 6 – 10% of AML patients have the IDH1 mutation. ● Nivestym™ (filgrastim-aafi): The FDA approved Pfizer’s Nivestym, a filgrastim biosimilar to Amgen’s Neupogen®, for the same indications as Neupogen, except for the treatment of patients acutely exposed to myelosuppressive doses of radiation (hematopoetic syndrome of acute radiation syndrome). Nivestym follows Sandoz’s biosimilar to Neupogen, Zarxio®, which has been available since 2015. New indications ● Cinryze® (C1 esterase inhibitor [human]): The FDA expanded the indication for Shire’s Cinryze to include pediatric patients with hereditary angioedema (HAE) to use for routine prophylaxis against HAE attacks in children 6 years of age and older. ● Keytruda (pembrolizumab): Merck received FDA approval for Keytruda for the treatment of adult and pediatric patients with refractory primary mediastinal B-cell lymphoma (PMBCL) who relapsed after, were refractory to, or were ineligible for bone marrow transplant and failed two or more prior lines of therapy.
    [Show full text]
  • Pharmaceuticals and Medical Devices Safety Information No
    Pharmaceuticals and Medical Devices Safety Information No. 370 February 2020 Table of Contents 1. For the Promotion of Pediatric Clinical Development (development and safety measures) through Active Use of Medical Information Database (Part 1) Maintaining the Pediatric Medical Data Collecting System and Examples of a Survey on the Drug Use in Children through Active Use of the System ..................................... 4 2. Post-Marketing Information Collection and Malfunctions Report from Medical Institutions for Medical Devices ................................ 9 3. Important Safety Information .............................................................14 1. Ipragliflozin L-Proline ............................................................................... 14 2. Olmesartan medoxomil ........................................................................... 16 3. Secukinumab (genetical recombination) .............................................. 19 4. Revision of Precautions (No. 310) ...................................................21 [1] Levodopa, [2] Levodopa/carbidopa hydrate, [3] Levodopa/benserazide hydrochloride (and 6 others) 5. List of Products Subject to Early Post-marketing Phase Vigilance ............................................24 Access to the latest safety information is available via the This Pharmaceuticals and Medical Devices Safety PMDA Medi-navi. Information (PMDSI) publication is issued reflective of safety information collected by the Ministry of Health, Labour and Welfare (MHLW). It is intended to
    [Show full text]
  • CHMP Agenda of the 19-22 April 2021 Meeting
    28 July 2021 EMA/CHMP/220334/2021 Corr.11 Human Medicines Division Committee for medicinal products for human use (CHMP) Agenda for the meeting on 19-22 April 2021 Chair: Harald Enzmann – Vice-Chair: Bruno Sepodes 19 April 2021, 09:00 – 19:30, virtual meeting/ room 1C 20 April 2021, 08:30 – 19:30, virtual meeting/ room 1C 21 April 2021, 08:30 – 19:30, virtual meeting/ room 1D 22 April 2021, 08:30 – 19:00, virtual meeting/ room 1C Disclaimers Some of the information contained in this agenda is considered commercially confidential or sensitive and therefore not disclosed. With regard to intended therapeutic indications or procedure scopes listed against products, it must be noted that these may not reflect the full wording proposed by applicants and may also vary during the course of the review. Additional details on some of these procedures will be published in the CHMP meeting highlights once the procedures are finalised and start of referrals will also be available. Of note, this agenda is a working document primarily designed for CHMP members and the work the Committee undertakes. Note on access to documents Some documents mentioned in the agenda cannot be released at present following a request for access to documents within the framework of Regulation (EC) No 1049/2001 as they are subject to on- going procedures for which a final decision has not yet been adopted. They will become public when adopted or considered public according to the principles stated in the Agency policy on access to documents (EMA/127362/2006). 1 Correction in section 8.1.1 Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 An agency of the European Union © European Medicines Agency, 2021.
    [Show full text]
  • New Indications & Dosage Froms for Existing Drugs
    New IndicationsDrug Approvals & Dosage Forms for Existing Drugs 89 New Indications & Dosage Froms for Existing Drugs 1. Tagrisso (osimertinib) Tablets Genentech announces FDA approval of Xolair New Indication Approved: December 20, 2020 (omalizumab) for adults with nasal polyps. Date of Original Approval: November 13, 2015 7. Hetlioz (tasimelteon) Capsules Tagrisso approved in the US for the adjuvant New Indication Approved: December 1, 2020 treatment of patients with early-stage EGFR-mutated Date of Original Approval: January 31, 2014 non-small cell lung cancer. Previously treated EGFR FDA approves Hetlioz (tasimelteon) for the treatment T790M mutation-positive metastatic NSCLC. of nighttime sleep disturbances in smith-magenis 2. Xpovio (selinexor) Tablets syndrome. New Indication Approved: December 18, 2020 8. Xofluza (baloxavirmarboxil) Tablets and Date of Original Approval: July 3, 2019 Granules for Oral Suspension Karyopharm Announces FDA approval of Xpovio New Indication Approved: November 23, 2020 (selinexor) as a treatment for patients with multiple Date of Original Approval: October 24, 2018 myeloma after at least one prior therapy. Genentech announces FDA approval of Xofluza for 3. Ocrevus (ocrelizumab) Injection the prevention of influenza following contact with an New Dosage Regimen: December 14, 2020 infected person. Date of Original Approval: March 28, 2017 9. Imfinzi (durvalumab) Injection FDA approves Genentech’s Ocrevus (ocrelizumab) New Dosage Regimen: November 18, 2020 shorter 2-hour infusion for relapsing and primary Date of Original Approval: May 1, 2017 progressive multiple sclerosis. For the treatment of adult patients with locally 4. Saxenda (liraglutide) Injection advanced or metastatic urothelial carcinoma. Patient Population Altered: December 4, 2020 10. Vimpat (Lacosamide) Tablets, Injection, Oral Date of Original Approval: December 23, 2014 Solution FDA approves Saxenda (liraglutide) for the treatment New Indication Approved: November 16, 2020 of obesity in adolescents aged 12-17.
    [Show full text]
  • MAXIMUM DOSAGE & FREQUENCY Policy Number: CSLA2020D0034X Effective Date: TBD
    Proprietary Information of United Healthcare: The information contained in this document is proprietary and the sole property of United HealthCare Services, Inc. Unauthorized copying, use and distribution of this information are strictly prohibited. Copyright 2020 United HealthCare Services, Inc. UnitedHealthcare® Community Plan Medical Benefit Drug Policy MAXIMUM DOSAGE & FREQUENCY Policy Number: CSLA2020D0034X Effective Date: TBD Table of Contents Page Related Community Plan Policies APPLICATION .......................................................... 1 Cimzia® (Certolizumab Pegol) COVERAGE RATIONALE ............................................. 1 Complement Inhibitors (Soliris® & Ultomiris™) APPLICABLE CODES ................................................. 3 Denosumab (Prolia® & Xgeva®) CLINICAL EVIDENCE ................................................ 21 Entyvio® (Vedolizumab) CENTERS FOR MEDICARE AND MEDICAID SERVICES ... 21 ® REFERENCES .......................................................... 22 Infliximab (Remicade , Inflectra™, Renflexis™) POLICY HISTORY/REVISION INFORMATION ................ 24 Oncology Medication Clinical Coverage INSTRUCTIONS FOR USE ......................................... 24 Onpattro™ (Patisiran) Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors Rituximab (Rituxan®, Ruxience™, & Truxima®) Stelara® (Ustekinumab) White Blood Cell Colony Stimulating Factors Xolair® (Omalizumab) Commercial Policy Maximum Dosage APPLICATION This Medical Benefit Drug Policy only applies
    [Show full text]
  • Infusion Site of Care and Specialty Pharmacy
    2021 SPECIALTY DRUGS PREAUTHORIZATION LIST FOR INFUSION SITE-OF-CARE or PROVIDER ADMINISTERED DRUG THERAPIES (Including Cellular Immunotherapy, Gene Therapy and Other Medical Benefit Drug Therapies) General Information: Preauthorization is required by BCBSMT for certain services to determine in advance the Medical Necessity or Experimental, Investigational and/or Unproven nature of certain care and services based on MCG Criteria, Medical Policy and Member benefits. The list below describes the services that require preauthorization. Predetermination is a process used to submit requests for review of coverage decisions in accordance with Medical Policy and Member contracts for a service (i.e., procedure, supply, drug or device) used to diagnose or treat an illness or condition. A predetermination is recommended if a provider is uncertain if the service meets Medical Policy criteria. Contact provider customer service to determine if a service not on this list is subject to Medical Necessity review. The presence of codes on this list does not necessarily indicate coverage under the Member benefits contract. Member contracts differ in their benefits. Consult the Member contract or contact a provider customer service representative to determine coverage for a specific drug code. Providers may also check eligibility and benefits through Availity® or the provider's preferred vendor to determine if a preauthorization is required. Not all requirements apply to each BCBSMT benefit plan. PRESS "CTRL" AND "F" KEYS AT THE SAME TIME TO BRING UP THE
    [Show full text]
  • Soluble Ligands As Drug Targets
    REVIEWS Soluble ligands as drug targets Misty M. Attwood 1, Jörgen Jonsson1, Mathias Rask- Andersen 2 and Helgi B. Schiöth 1,3 ✉ Abstract | Historically, the main classes of drug targets have been receptors, enzymes, ion channels and transporters. However, owing largely to the rise of antibody- based therapies in the past two decades, soluble protein ligands such as inflammatory cytokines have become an increasingly important class of drug targets. In this Review, we analyse drugs targeting ligands that have reached clinical development at some point since 1992. We identify 291 drugs that target 99 unique ligands, and we discuss trends in the characteristics of the ligands, drugs and indications for which they have been tested. In the last 5 years, the number of ligand-targeting drugs approved by the FDA has doubled to 34, while the number of clinically validated ligand targets has doubled to 22. Cytokines and growth factors are the predominant types of targeted ligands (70%), and inflammation and autoimmune disorders, cancer and ophthalmological diseases are the top therapeutic areas for both approved agents and agents in clinical studies, reflecting the central role of cytokine and/or growth factor pathways in such diseases. Drug targets In the twentieth century, drug discovery largely involved far more challenging to achieve with small- molecule Pharmacological targets, such the identification of small molecules that exert their drugs. Protein ligands have been successfully targeted as proteins, that mediate the therapeutic effects by interacting with the binding sites by many drugs since the first FDA approval of the desired therapeutic effect of of endogenous small- molecule ligands such as neuro- ligand- targeting agents etanercept and infliximab in a drug.
    [Show full text]
  • Overview of Planned Or Ongoing Studies of Drugs for the Treatment of COVID-19
    Version of 16.06.2020 Overview of planned or ongoing studies of drugs for the treatment of COVID-19 Table of contents Antiviral drugs ............................................................................................................................................................. 4 Remdesivir ......................................................................................................................................................... 4 Lopinavir + Ritonavir (Kaletra) ........................................................................................................................... 7 Favipiravir (Avigan) .......................................................................................................................................... 14 Darunavir + cobicistat or ritonavir ................................................................................................................... 18 Umifenovir (Arbidol) ........................................................................................................................................ 19 Other antiviral drugs ........................................................................................................................................ 20 Antineoplastic and immunomodulating agents ....................................................................................................... 24 Convalescent Plasma ...........................................................................................................................................
    [Show full text]
  • Place of Service for Medical Infusions “Notification” POLICY EFFECTIVE OCTOBER 1, 2021
    Corporate Medical Policy: Place of Service for Medical Infusions “Notification” POLICY EFFECTIVE OCTOBER 1, 2021 Related Corporate Medical Policies with Applicable Restricted Product(s): • Abatacept (Orencia®) • Alpha 1-Antitrypsin Inhibitor Therapy • Belimumab (Benlysta®) • Burosumab-twza (Crysvita®) • Canakinumab (Ilaris®) • Certolizumab pegol (Cimzia®) • Crizanlizumab-tmca (Adakveo®) • Eculizumab (Soliris®) • Edaravone (Radicava®) • Enzyme Replacement Therapy (ERT) for Lysosomal Storage Disorders • Eptinezumab-jjmr (Vyepti™) • Evinacumab-dgnb (Evkeeza™) • Fosdenopterin (Nulibry™) • Givosiran (Givlaari®) • Golimumab (Simponi Aria®) • Guselkumab (Tremfya®) • Ibalizumab-uiyk (Trogarzo®) • Immunoglobulin Therapy • Inebilizumab-cdon (Uplizna™) • Infliximab (Remicade®) and Infliximab Biosimilars • Interleukin-5 Antagonists • Letermovir (Prevymis™) • Lumasiran (Oxlumo™) • Luspatercept-aamt (Reblozyl®) • Natalizumab (Tysabri®) • Ocrelizumab (Ocrevus®) • Omalizumab (Xolair®) BLUE CROSS®, BLUE SHIELD® and the Cross and Shield Symbols are registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. Blue Cross NC is an independent licensee of the Blue Cross and Blue Shield Association. All other marks are the property of their respective owners. Page 1 October 2021 • Patisiran (Onpattro®) • Pegcetacoplan (Empaveli™) • Plasminogen, human-tvmh (Ryplazim®) • Ravulizumab-cwvz (Ultomiris®) • Romiplostim (NPlate®) • Romosozumab-aqqg (Evenity™) • Somatostatin Analogs • Teprotumumab-trbw
    [Show full text]
  • Medication Matters Confirmed COVID-19 Pneumonia
    Potential Bacterial Co-infection with COVID-19 Pneumonia? Andrew Wang, Pharm.D.; BCPS, BCIDP One of the questions often asked by providers is whether a patient should be Hughes et al., performed a retrospective cohort study investigating the incidence started on antibiotics to cover for potential co-bacterial infection in patients with of bacterial and fungal co-infection of hospitalized patients in a UK secondary care Medication Matters confirmed COVID-19 pneumonia. This question stems ultimately from concerns setting. 836 laboratory-confirmed COVID-19 patients were evaluated, and it was November 2020 Pharmacy Medication Safety Alerts of co-bacterial and viral infections, as bacterial co-pathogens are commonly found that the overall incidence was 6.1% and only 3.2% for patients who were identified in viral respiratory tract infections such as influenza and are an important hospitalized 0-5 days. The most common pathogen identified was Pseudomonas cause of morbidity and mortality. In the most recent IDSA Community Acquired spp (9 patients) and S. aureus (4 patients). There was a 0% positivity rate for Pneumonia (CAP) guidelines, current literature supports that adults with clinical Legionella and streptococcal urinary antigen test. Lastly, surprisingly, Candida and radiographic evidence of CAP who test positive for influenza in the inpatient spp. was found in 21.4% of the samples; however, the authors postulated that LIFEBRIDGE HEALTH FORMULARY REVIEW COMMITTEE UPDATES and outpatient settings should be treated concurrently with antibiotics. This was this likely represented oropharyngeal thrush or normal flora rather than pulmonary LifeBridge Health Formulary Review Committee Updates based on evidence suggesting that bacterial coinfections as bacterial pneumonia candidiasis.
    [Show full text]
  • Payor Strategies to Drive Biosimilars Access and Savings Grx+Biosims Conference 2019
    Payor Strategies to Drive Biosimilars Access and Savings GRx+Biosims Conference 2019 November 4, 2019 Amy Gutierrez, PharmD Senior Vice President and Chief Pharmacy Officer Kaiser Permanente National Pharmacy Programs and Services Discussion Today • Biosimilars Overview • Kaiser Permanente Experience with Biosimilar Therapy • Addressing Challenges for Biosimilars in the U.S. Market Unsustainable Rising Drug Costs – US Marketplace • 1 in 4 people have a difficult time affording their medications1 • Newer, innovative therapies cost ~$500K-$2M per patient . CAR-T therapy . Gene therapy • Specialty drugs now account for more than half of drug budgets in many organizations • How can we afford to provide these therapies? Source: Kaiser Family Foundation Health Tracking Poll (conducted Aug 6-11, 2015) Specialty Drug Trends 2013-2023 Specialty Drugs as a Percentage of Pharmacy Industry Prescription Revenues, 2013 to 2018 44% 34.5% 33.5% 31.0% 29.0% 25.5% 23.8% Revenues Specialty as a Percentage of Pharmacy Industry Prescription Prescription Industry of Pharmacy asa Specialty Percentage 2013 2014 2015 2016 2017 2018 2023 * Includes retail, mail, long-term care, and specialty pharmacies Source: 2019 Economic Report on US Pharmacies and Pharmacy Benefits Managers - Drug Channels Institute New Prescription Abandonment Rate by Patient Co-Pay Amount % Abandonment 80% 70% 69% 60% 52% 50% 40% 35% 30% 29% 21% 20% 16% 14% 12% 10% 8% 0% under $10 $10-$30 $20-$30 $30-$40 $40-$50 $50-$75 $75-$125 $125-$250 Over $250 % Abandonment 2019 Economic Report on US
    [Show full text]
  • John Hopkins Medicine Medicare Advantage Novologix Prior
    Advantage MD Medical Benefit (Part B) Drug Prior Authorization List *These prior authorization requirements impact all Advantage MD members.* Drug Name Please note: Brand name examples are HCPCS HCPCS Description included for reference only, and are not all- inclusive Q2053 Brexucabtagene autoleucel, up to 200 million autologous anti-cd19 car positive viable t Tecartus cells, including leukapheresis and dose preparation procedures, per therapeutic dose J0129 Injection, abatacept, 10 mg (code may be used for medicare when drug administered Orencia under the direct supervision of a physician, not for use when drug is self administered) J0178 Injection, aflibercept, 1 mg Eylea J0179 Injection, brolucizumab-dbll, 1 mg Beovu J0202 Injection, alemtuzumab, 1 mg Lemtrada J0221 Injection, alglucosidase alfa, (lumizyme), 10 mg Lumizyme J0222 Injection, patisiran, 0.1 mg Onpattro J0223 Injection, givosiran, 0.5 mg Givlaari J0256 Injection, alpha 1 proteinase inhibitor (human), not otherwise specified, 10 mg Aralast NP, Prolastin-C, Zemaira J0257 Injection, alpha 1 proteinase inhibitor (human), (glassia), 10 mg Glassia J0490 Injection, belimumab, 10 mg Benlysta J0517 Injection, benralizumab, 1 mg Fasenra J0584 Injection, burosumab-twza 1 mg Crysvita J0585 Injection, onabotulinumtoxina, 1 unit Botox J0586 Injection, abobotulinumtoxina, 5 units Dysport J0587 Injection, rimabotulinumtoxinb, 100 units Myobloc J0588 Injection, incobotulinumtoxin a, 1 unit Xeomin J0593 Injection, lanadelumab-flyo, 1 mg (code may be used for Medicare when drug Takhzyro
    [Show full text]