APA

The Voice of Pharmacy in Alabama

 

Pharmacy Legislative Updates
2010 Alabama Bills Impacting Pharmacy (view)

Pharmacy News

FDA News

FDA Generic Drug Approvals

H1N1 News and Updates

  Pharmacist's Pandemic Preparedness Guide (download pdf)

  Business Pandemic Influenza Checklist (download pdf)

Need to Know

  Haiti Earthquake Resources for Clinicians

  Update on the Prescription Origin Code

  Roche Tamiflu Updates

  Annual Inventory of Controlled Substances

  CMS Delays Ban on Faxed Prescriptions Deadline Moved to Jan. 1, 2012

News You Can Use

Other Pharmacy News

Alabama Medicaid ALERTS (view details)

1) Recipient Access to Contraceptive Products Under Plan First
2) Pharmacy Reimbursement for Administration of Seasonal Influenza and H1N1 Vaccines

Report on Pharmacy Education and Training: Relevance to Clinical Practice and the Expanding Role of Pharmacists

(read the article)

Product News

Exjade (deferasirox): Boxed Warning

(posted 2/18/10) (read more)

FDA Announces New Safety Controls for Long-Acting Beta Agonists, Medications Used to Treat Asthma

(posted 2/18/10) (read more)

FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemiag

(posted 2/18/10) (read more)

FDA Warns about Serious Side Effects from Maalox Product Mix-Ups

(posted 2/17/10) (read more)

Recall of Influenza A (H1N1) 2009 Monovalent Vaccine
(posted 2/17/10) (read more)


Field Correction of Influenza A (H1N1) 2009 Monovalent Vaccine in Prefilled Syringes
(posted 2/17/10) (read more)

Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication

(posted 2/16/10) (read more)

FDA Announces New Safety Plan for Agents Used to Treat Chemotherapy-Related Anemia

(posted 2/16/10) (read more)

FDA Approves New Indication for Crestor

(posted 2/9/10) (read more)

BD Q-Syte Luer Access Devices: Recall
BD Q-Syte Luer Access Devices
BD Nexiva Closed IV Catheter Systems
Acacia IV Extension Sets with BD Q-Syte Luer Access Device

(posted 2/9/10) (read more)

Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall

(posted 2/9/10) (read more)

BD Announces Worldwide Voluntary Recall ofBD Q-Syte™ Luer Access Devices and BD Nexiva™ Closed IV Catheter Systems

(posted 2/8/10) (read more)

Tysabri (Natalizumab): Update of Healthcare Professional Information

The U.S. Food and Drug Administration (FDA) is alerting the public that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with the use of Tysabri (natalizumab), increases with the number of Tysabri infusions received.

(posted 2/5/10) (read more)

Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical

(posted 2/5/10) (read more)

Cardiac Science Notifies AED Customers of Voluntary Medical Device Recall

(posted 2/3/10) (read more)

FDA Approves Xiaflex for Debilitating Hand Condition

(posted 2/2/10) (read more)

Zyprexa (olanzapine): Use in Adolescents

(posted 2/1/10) (read more)

FDA Announces Safety Risk Associated with HIV Drug

(posted 2/1/10) (read more)

FDA Expands Use of Approved Breast Cancer Drug

(posted 1/29/10) (read more)

United States Seizes Unapproved Ozone Generators

(posted 1/29/10) (read more)

FDA Drug Safety Communication: Serious liver disorder associated with the use of Videx/Videx EC (didanosine)

(posted 1/29/10) (read more)

Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall

(posted 1/28/10) (read more)

FDA Announces Class I Recall of Certain Infusion Set Needle

(posted 1/27/10) (read more)

FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain

(posted 1/27/10) (read more)

Propofol Injection Shortage

(posted 1/26/10) (read more)

FDA Approves Victoza (liraglutide) for Type 2 Diabetes

(posted 1/25/10) (read more)

Questions and Answers - Safety Requirements for Victoza (liraglutide)

(read more)

The FDA Data Standards Council’s website was updated Sunday, January 24, 2010, to include updated terminology:

A. UNII update - http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162523.htm
B. Updated terminology XML File - http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm

(posted 1/24/10)

FDA Warns Consumers about Counterfeit Alli

People may be taking 3-times the usual daily dose

(updated 1/23/10) (read more)

FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis

(posted 1/23/10) (read more)

Nipro GlucoPro Insulin Syringes: Recall

(posted 1/22/10) (read more)

Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review

(posted 1/21/10) (read more)

McNeil Consumer Healthcare Over-The-Counter Products: Recall

McNeil and FDA notified healthcare professionals of an expansion of the December 2009 recall.

(updated 1/15/10) (read more)

MuscleMaster.com Products Sold on Internet as Dietary Supplements: Recall

(posted 1/15/10) (read more)

FDA announces a new Web resource, FDA Basics

FDA Basics answers your questions and discusses other important public health topics in a useful and user-friendly format

(posted 1/15/10) (read more)

FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler

(posted 1/14/10) (read more)


Letter to Healthcare Professionals from FDA Commissioner Margaret Hamburg

(posted 1/14/10) (read the letter)

USP recalls USP 33–NF 28

Substantive errors found in latest version of compendium

(posted 1/12/10) (read more)

FDA Approves New Drug for Rheumatoid Arthritis 

(posted 1/11/10) (read more)

FDA Requires Sybaritic, Inc. to Stop Producing Unapproved Medical Devices 

(posted 1/8/10) (read more)

New Schedule for Childhood Vaccines 

(posted 1/6/10) (read more)

FDA Warns Public of Continued Extortion Scam by FDA Impersonators 

(posted 12/23/09) (read more)

FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older

(posted 12/23/09) (read more)

FDA Approves Generic Aricept to Treat Dementia Related to Alzheimer’s Disease

(posted 12/16/09)  (read more)

Non-Safety-Related Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine in Pre-Filled Syringes

Questions & Answers (posted 12/16/09)  (read more)

Fraudulent Emails Referencing CDC-sponsored State Vaccination Program
(posted 12/15/09)  (read more)

America Unprepared for Disaster  (posted 12/15/09)  (read more)

Shortage of Erythromycin Ophthalmic Ointment for Newborns

(read letter from CDC)

FDA Launches New Pet Health and Safety Widget
(posted 12/8/09)
The U.S. Food and Drug Administration today launched its pet health and safety widget for consumers as part of an ongoing effort to provide timely, user-friendly, public health information.
(read more)

FDA Approves Kalbitor for Treating Potentially Life-Threatening Attacks of Hereditary Angioedema

(posted 12/2/09) (read more)

FDA Approves Agriflu Seasonal Influenza Vaccine
(posted 12/1/09)
The U.S. Food and Drug Administration has approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B. (read more)

Single Lot of Sinex VapoSpray Recalled

Potential bacterial contamination cited.

(posted 11/23/09)

Procter & Gamble has recalled lot number 9239028831 of Sinex VapoSpray 12-hour Decongestant Ultra Fine Mist Nasal Spray 15 ml . At a German plant, bacterial contamination was found in this product, and while no adverse events have been reported, the recall was initiated as a precaution. (read more)

New FDA Web Page Lists Disposal Instructions for Select Medicines

(posted 10/16/09)

The U.S. Food and Drug Administration has launched a Web page for consumers with information on how to dispose of certain drugs, including several high-potency opioids and other selected controlled substances. (learn more)

FDA Issues Alert for Stolen Advair Diskus

(posted 8/26/09)

On 8/26/09 the FDA issued an alert for a pharmaceutical theft of 14,400 units of Advair Diskus 250/50 oral inhaler and 11,200 units of Advair Diskus 500/50 oral inhaler that were stolen on August 2, 2009 from the GlaxoSmithKline distribution facility near Richmond, Virginia. The FDA is requesting assistance from pharmaceutical drug distributors and pharmacies that may receive offers for the stolen drug products described below. It is important to note that these lots were awaiting distribution to retail pharmacies at the time of the theft, therefore, these products should not be in the legitimate pharmaceutical supply chain.
If you receive any offers for stolen Advair Diskus products or think that you may have been sold any stolen Advair Diskus products referenced in this notice, the FDA is asking your help in reporting this information to FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989 or by visiting the OCI web site (http://www.fda.gov/OCI).
Patients who have inhalers with these lot numbers should return them to the pharmacy where they were dispensed.
Also see GlaxoSmithKline’s Advisory issued on August 24, 2009: http://news.prnewswire.com/ViewContent.aspx?ACCT=109&STORY=/www/story/08-24-2009/0005082224&EDATE=


Stolen Products:
• Advair Diskus 250/50
Strength: fluticasone propionate 250 mcg/ salmeterol 50 mcg
Each unit contains 60 blisters of oral powder for inhalation
Lot # 9ZP2255 NDC 0173-0696-00

• Advair Diskus 500/50
Strength: fluticasone propionate 500 mcg/ salmeterol 50mcg
Each unit contains 60 blisters of oral powder for inhalation
Lot # 9ZP3325 NDC 0173-0697-00

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New and Generic Drug Approvals

February 23, 2010
• Levofloxacin Tablets, Torrent Pharmaceuticals Ltd., Tentative Approval
• Norvasc (amlodipine besylate) Tablets, Pfizer Inc., Labeling Revision
• Ursodiol Capsules, Mylan Pharmaceuticals Inc., Approval
• Valproate Sodium Injection, Hikma Farmaceutica, Approval

February 17, 2010

• Ciclopirox2 Shampoo, Perrigo Co., of Tennessee, Inc., Approval
• Pristiq3 (desvenlafaxine succinate) Extended-Release Tablets, Wyeth Pharmaceuticals, Inc., Labeling Revision
• Sulfamethoxazole and Trimethoprim4 Tablets USP, Aurobindo Pharma Ltd., Approval

February 4, 2010
• Accutane (isotretinoin) Capsules, Hoffmann-La Roche Inc., Labeling Revision
• Cancidas (caspofungin acetate) I.V. Injection, Merck Research Laboratories, Labeling Revision
• Exjade (deferasirox) Oral Suspension Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
• Kaletra (lopinavir and ritonavir) Tablets, Abbott Laboratories, Labeling Revision
• Kaletra (lopinavir and ritonavir) Oral Solution, Abbott Laboratories, Labeling Revision
• Kenalog-10 (triamcinolone acetonide) Injection, Apothecon Inc., Labeling Revision
• Kenalog-40 (triamcinolone acetonide) Injection, Apothecon Inc., Labeling Revision
• Oleptro (trazodone hydrochloride) Extended-Release Tablets, Labopharm Canada, Approval
• Olopatadine Hydrochloride Ophthalmic Solution, Sandoz Inc., Tentative Approval
• PEG 3350 and Electrolytes (polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride and sodium sulfate anhydrous) Oral Solution, Mylan Pharmaceuticals Inc., Approval
• Pexeva (paroxetine mesylate) Tablets, Noven Therapeutics, LLC, Labeling Revision
• Prezista (darunavir ethanolate) Tablets, Tibotec Inc., Efficacy Supplement

January 25, 2010
• AMPYRA (dalfampridine) Extended-Release Tablets, Acorda Therapeutics, Inc., Approval
• Bumex (bumetanide) Tablets, Validus Pharmaceuticals, Labeling Revision
• Coumadin (warfarin sodium) Tablets, Bristol-Myers Squibb Co., Labeling Revision
• Crestor (rosuvastatin calcium) Tablets, IPR Pharmaceuticals, Inc., Labeling Revision
• Ethrane (enflurane) Inhalation Liquid, Baxter Healthcare Corp., Labeling Revision
• Lusedra (fospropofol disodium) I.V. Solution, Eisai Inc., Labeling Revision
• Mephyton (Phytonadione) Tablets, Aton Pharma, Inc., Labeling Revision
• Milrinone Lactate in Plastic Containers Injection, Hikma Farmaceutica, Approval
• Qualaquin (quinine sulfate) Capsules, AR Holding Company, Inc., Labeling Revision
• Reyataz (atazanavir sulfate) Capsules, Bristol-Myers Squibb Co., Labeling Revision
• Trandolapril and Verapamil Hydrochloride Extended-Release Tablets, Glenmark Generics, Tentative Approval
• Ultane (sevoflurane) Liquid Inhalation, Abbott Laboratories, Labeling Revision

January 22, 2010 (learn more)

• Ampicillin Sodium Injection, ACIC Fine Chemicals, Inc., Approval
• Finasteride Tablets, Zydus Pharmaceuticals, Approval
• Fluvastatin Capsules, Mylan Pharmaceuticals, Inc., Tentative Approval
• Gemcitabine Injection, Actavis Totowa, LLC, Tentative Approval
• Ibandronate Sodium Tablets, Mylan Pharmaceuticals, Inc., Tentative Approval
• Lamivudine and Zidovudine Tablets, TEVA Pharmaceuticals, Tentative Approval
• Latanoprost Ophthalmic Solution, Apotex, Inc., Tentative Approval
• Nicardipine Hydrochloride Injection, Bedford Laboratories, Approval


H1N1 News

Shortened shelf life of 13 lots of MedImmune H1N1 influenza nasal spray vaccine

Company announces limited, voluntary, non–safety-related recall of remaining unused product

(posted 12/29/09) (read more)

FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older

(posted 12/23/09) (read more)

IMPORTANT H1N1 VACCINE ORDERS UPDATE FROM ADPH
(posted 12/16/09)
A message from the Alabama Department of Public Health to H1N1 Vaccine Providers:
We appreciate your service in partnership with public health to respond to H1N1 influenza disease. We regret the difficulties and limitations created by delays in production of vaccine from the manufacturers and our subsequent inability to fill all requests for vaccine. H1N1 still exists as a threat and we now have additional doses to expand vaccine protection to our entire community. Time and circumstance make it necessary to update provider needs for H1N1 vaccine. We are cancelling all pending orders effective December 14, 2009. In addition, all providers who have received vaccine must report their remaining inventory on hand. Providers who desire additional vaccine will need to place a fresh order. To report your inventory or to place a fresh order, please log onto the ADPH ORDER site (adph.org, Log-In, ORDER) choose the menu option “H1N1 Vaccine – Report/Order”, then take the following steps:
1. If you have received any vaccine, report doses on hand by December 18, 2009. Enter the number of vaccine doses on hand remaining from your previous shipments. We ask that you summarize the doses remaining in three groups: mist, infant injectable (6-35 months), and other injectables. If you have none remaining, report zero(s), where applicable.
2. If you desire vaccine, place a fresh order. Again, you will order by three groups: mist, infant injectable (6-35 months), and other injectables. If you do not need additional doses, please select "No".
Summary: Any doses remaining on past orders have been canceled. Report doses on hand if you have previously received vaccine. Submit a fresh order if you desire vaccine.
In considering your needs, please note:
1. H1N1 disease is still widespread in Alabama. School absenteeism is still far above average and virtually all flu confirmations are H1N1.
2. A major public awareness campaign ("advertising push") is imminent. Public Health will begin a major public information campaign to run through December and January on the safety, effectiveness and need for the vaccine.
3. The general public can be served. Vaccine stocks should be sufficient to open immunization efforts to the general public the week of December 22 including shipment of vaccine to pharmacies and mass vaccinators.
Thank you for your past and continued work to protect our communities

NEW! H1N1 Newsletter from ADPH

(posted 12/1/09)

(download newsletter)

Pneumococcus Vaccines Recommended to Decrease Secondary Infections Associated with H1N1, Seasonal Influenza
(posted 12/1/09)
ACIP recently recommended that all individuals older than 65 years and certain high-risk patients be vaccinated against Streptococcus pneumoniae (pneumococcus) using the 23-valent pneumococcal polysaccharide vaccine. (read more)

Guidance on Reallocating Influenza Vaccine

(posted 11/24/09)

CDC answers questions on sharing, transferring, and selling vaccine.

The CDC webpage Reallocating influenza vaccine provides guidance to pharmacists and other health providers regarding sharing, transferring, and selling vaccine amongst themselves. Public health departments and health care providers and institutions that are considering reallocating influenza vaccine should be aware of the following information from FDA:

Under Section 503(c)(3)(B)(iv) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a health care entity may sell, purchase, or trade (or offer to do the same with) influenza vaccine to alleviate a shortage if a reasonable basis exists for concluding that a shortage of influenza vaccine has occurred or will occur. A shortage includes a temporary shortage arising from delays in or interruptions of regular distribution schedules.

(read more)

FDA Approves Additional Vaccine for 2009 H1N1 Influenza Virus

(posted 11/16/09)

The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC. (read more)

Blue Cross Blue Shield Change in Filing Process for H1N1 Vaccines
(posted 11/9/09)

On October 15, 2009, information on tracking H1N1 vaccines was proivided to Alabama Pharmacists from BC/BS. Please note that the Alabama Department of Public Health will be taking a different approach in gathering this data. Therefore, BC/BS will no longer need you to file claims for the uninsured as previously requested. BC/BS appreciates your willingness to assist us in this endeavor. If you have any questions please feel free to contact Becky Tutwiler, Senior Pharmacy Network Analyst at 205-220-6545.

H1N1 Swine Flu Deadly in All Age Groups

(posted 11/5/09)

H1N1 swine flu isn't always severe, but when it's bad, it's really bad. Patients hospitalized with pandemic flu have an 11% fatality rate, data from California suggest.

The pandemic flu bug is far more likely to strike younger people. But when people aged 50 and older get hospitalized with H1N1 swine flu, their case-fatality rate is the highest of any group: 18% to 20%. (read story)

Roche Updates Regarding Availability of Tamiflu Antiviral Flu Medication, Mixing and Dosing Options

(posted 11/2/09)

(read more)

Alabama Medicaid ALERTS (view details)

(posted 11/2/09)

1) Recipient Access to Contraceptive Products Under Plan First
2) Pharmacy Reimbursement for Administration of Seasonal Influenza and H1N1 Vaccine

Summarized Billing Recommendations for 2009 H1N1 Vaccine

(posted 10/26/09)

Organizations provide guidance to aid pharmacists in billing for 2009 H1N1

(read more)

FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use

(posted 10/26/09)

The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older. (read more)

H1N1 Swine Flu Deadly to the Young

(posted 10/26/09)

88% of H1N1 Swine Flu Deaths Are People Under Age 65, Reversing Seasonal Trend

In a normal flu season, 90% of deaths are in elderly people. Since September, 90% of deaths have been in people under age 65 -- with almost a quarter of the deaths in young people under age 25. (read more)

Vaccine Information Statements From the CDC

(posted 10/5/09)

Live, Intranasal 2009 H1N1 Influenza Vaccine (download flyer)

Inactivated 2009 H1N1 Influenza Vaccine (download flyer)

Vaccine Information Statements (VISs) are information sheets produced by the Centers for Disease Control and Prevention (CDC) that explain to vaccine recipients, their parents, or their legal representatives both the benefits and risks of a vaccine. Federal law requires that VISs be handed out whenever (before each dose) certain vaccinations are given.

Roche Tamiflu Updates

On behalf of Roche, please find updates below regarding availability of Tamiflu antiviral flu medication, as well as mixing and dosing options.

As you may know, Tamiflu is one of two antiviral medications that are effective against the H1N1 pandemic virus. Tamiflu is available in capsule and liquid (oral suspension) formulations. There are millions of treatment courses of Tamiflu in the U.S., and Roche continues to make all formulations of Tamiflu. However, deliveries of the liquid form to some locations are going to be sporadic this fall.

To ensure the company can meet public health needs during the H1N1 pandemic, Roche increased the production of the 75 mg capsules that can be used by adults or converted to a liquid for children, therefore making the medicine available to whomever may need it. By doing this, Roche can make medicine for 25 times the number of children in the same amount of time it would normally take to make liquid version for one child.

As you likely already know, pharmacists may need to compound a liquid suspension using Tamiflu capsules. Instructions were approved by the FDA in 2006 and are included in the Tamiflu package insert.

To assist pharmacists and physicians, Roche developed the following materials:

1. For pharmacists -- Instructions for emergency compounding of oral suspension from 75 mg capsules (to be used when liquid suspension is not available). (read instructions)

2. For physicians/prescribers -- Dosing card with overview of available formulations and dosing recommendations for adults and children. (view dosing charts)

Additionally, you may know that Roche distributed a letter to U.S. pharmacists and other healthcare professionals to remind them to ensure that the units of measure written on the prescription for liquid formulations of Tamiflu are consistent with the units of measure on the device used to administer the medicine
(http://www.fda.gov/downloads/Safety/MedWatch/Safety Information/SafetyAlertsforHumanMedicalProducts/UCM183752.pdf).

Health professionals may direct questions to the Roche Pharmaceuticals Service Center at 1-800-526-6367.

As a reminder, Tamiflu is recommended by the CDC for treatment and prevention of seasonal influenza as well as pandemic H1N1 influenza (http://www.cdc.gov/H1N1flu/recommendations.htm). CDC also recently issued specific information for pharmacists regarding antivirals (http://www.cdc.gov/H1N1flu/pharmacist/pharmacist_info.htm).

CDC Health Advisory Regarding the Swine Flu

The most recent CDC information may be found at http://www.cdc.gov/swineflu/investigation.htm. The potential of this type of outbreak is especially of concern to those in the pharmacy profession. Pharmacists and pharmacy technicians will be among the first to see sick patients and to be exposed. Now is the time for pharmacies to activate their plans for dealing with a contagious disease outbreak.
In addition, pharmacists and pharmacy technicians will be in an excellent position to be the eyes of epidemiology and report possible cases to Alabama Department of Public Health's Epidemiology Division. The phone number to report possible cases is: 1-800-338-8374

For Hospitals, the AIMS system has been activated. The log in site is: https://www.al.aimslive.org/AIMS/Login.aspx. Most hospitals and many hospital pharmacists have been given AIMS training or updates and should be familiar with this program. (read more)

Ordering and Receiving H1N1 Vaccine Instructions for Pharmacists

(posted 9/21/09)

Vaccine can only be administered at a pharmacy under the direction of a medical protocol overseen and signed by an Alabama licensed physician, or pursuant to a prescription from a physician.
You will be able to obtain the H1N1 vaccine from the health department by logging on to the website and registering your store. Once registered you can order when the system is available. The vaccine, syringes/needles, sharps container, alcohol swabs will be provided for free.
Please let us know if you are willing to be a vaccinator in a mass clinic if ADPH determines the need to use pharmacists in these clinics.

Provider Agreement - H1N1 Vaccines
There will be a federally supplied provider agreement for vaccine that pharmacists will have to agree to.

Administration Costs and Billing for H1N1 Vaccine Administration Costs On Free Vaccine Received From ADPH:
The vaccine and supplies are free and supplied at no cost to vaccinators.
Some insurance companies will pay you an administration and some will not. You may charge your regular administration fee for the vaccine or bill the insurance company. If a patient can not pay you should provide it for no administration fee or refer the patient to the Health Department vaccination clinics. Since the vaccine and supplies will be provided free you will not be able to bill for these items.

Time Frame For Vaccines:
Supplies and vaccine will be available in the OCT - NOV time frame.

Ordering Notification:
Everyone will be notified when they can log on and order. In the interim it is very important to log on and register your pharmacy for vaccine ordering. So, if you plan to order H1N1 vaccine when it is available, register your intent to order when
available by visiting: https://dph.state.al.us/order/

This will help in planning and distribution to know ahead who will be ordering when the system is up and going. You do not have to order antivirals in order to register for the future potential to order vaccines.

Seasonal Yearly Flu Vaccine:
For regular flu vaccine you should start to administer it as soon as you get it.

Priority Groups For H1N1 Vaccine Available at: http://www.cdc.gov/h1n1flu/vaccination/acip.htm

Pharmacist Vaccinators Are Encouraged to Enroll in ImmPRINT

(posted 9/10/09)

Pharmacist vaccinators statewide are encouraged to become informed about and to register for ImmPRINT (Immunization Provider Registry with Internet Technology). The Immunization Division of the Alabama Department of Public Health manages this immunization registry. Alabama's immunization database, which began development in 1997, is accessible to vaccine providers and their staff statewide, free of charge, via the Internet. ImmPRINT is a population-based registry with patients of all ages. With each provider enrollment, immunization histories become more comprehensive.

For more information on ImmPRINT enrollment or to answer any other questions, please contact Mike Hudgens or Sharon Jenkins via the web at adph.org/immunization or by phone at 1.800.469.4599 or 1.334.206.5023

(back to top)


Need to Know

CMS extends deadline for DMEPOS suppliers

Non-accredited suppliers must discontinue services by March 1

(posted 2/12/10) (read more)

Additional Patient Care Opportunities to be Released!

(posted 2/11/10)
Mirixa Corporation anticipates launching initial Community CCRx? Welcome Program 2010 cases in mid-February. Visit www.Mirixa.com to log in and check for your available opportunities.

The Welcome Program is available to all new Community CCRx beneficiaries, and cases are created based on patient requests for service under the program. This program offers patients a comparison of the patient’s current medications to the Community CCRx formulary, and is designed for pharmacists to recommend cost-saving changes to the patient’s medication therapy. If you identify a new Community CCRx member, you should encourage the member to contact Community CCRx Customer Service at 866.684.5353 to request this service specifically at your pharmacy. Based on the patient’s request, your pharmacy will receive a Welcome Program patient care opportunity for that specific patient.

Medical supplies, drugs needed for Haitian relief efforts

(posted 2/2/10) (read more)

ACIP issues 2010 clinical guidelines regarding adult immunizations

(posted 1/29/10) (read more)

Antithrombotic polypharmacy increases bleeding complications after first myocardial infarction

(posted 1/29/10) (read more)

Alabama PEEHIP/Express Scripts plan year changes effective February 1, 2010

(posted 1/26/10) (read PEEHIP changes)

PEEHIP members are being switched to a new preferred Glucometer for blood glucose testing effective February 1, 2010. PEEHIP members can obtain a new Glucometer free from the manufacturer.

(posted 1/26/10) (read more)

Health Net Pharmacy Update: Medicare LIS Copay Issue

Some HEALTH NET LIS Members Being Charged Incorrect Copayment Amounts

(posted 1/26/10) (read more)

ADPH H1N1 Alabama Update

(posted 1/26/10) (read more)

Pharmacists, funds needed for Haiti relief efforts

(posted 1/26/10) (read more)

Haiti Earthquake Resources for Clinicians

(posted 1/19/10) (read more)

Massive OTC recall affects two dozen J&J products

(posted 1/16/10) (read more)

 

Haiti Earthquake Resources for Clinicians

The January 12 earthquake in Haiti has resulted in a huge response effort involving our global, domestic, government, and non-government partners. CDC has already deployed staff to assist in the effort and anticipates many more will be working in Haiti over the coming months. You may also be actively engaged in the response, or may become involved over time. The health and safety of the Haitian people is the focus of the response efforts. In order for that to be achieved, relief workers and volunteers must also be protected from injury and illness.
CDC has updated several fact sheets that provide information healthcare providers and responders can utilize before, during and after an earthquake.


Please find below the most up-to-date versions of the following documents:
• Guidance for Relief Workers and Others Traveling to Haiti for Earthquake Response
http://wwwnc.cdc.gov/travel/content/news-announcements/relief-workers-haiti.aspx

• Emergency Wound Management for Healthcare Professionals
http://emergency.cdc.gov/disasters/emergwoundhcp.asp

• After an Earthquake: Management of Crush Injuries & Crush Syndrome
http://emergency.cdc.gov/disasters/earthquakes/crush.asp
CDC's Earthquake Webpage includes many other resources for responders, and is being updated frequently. We hope you will visit http://emergency.cdc.gov/disasters/earthquakes/
Additional resources and links to information for you and your colleagues are below. Please feel free to contact us at COCA@cdc.gov if you need additional information.


Additional Earthquake Resources for Clinicians
• Health Recommendations for Relief Workers Responding to Disasters
http://wwwnc.cdc.gov/travel/content/relief-workers.aspx

• Public Health Issues and Priorities for the Haiti Earthquake
http://emergency.cdc.gov/disasters/earthquakes/healthconcerns_haiti.asp

• Travel Health Warning
http://wwwnc.cdc.gov/travel/content/travel-health-warning/haiti-earthquake.aspx

• CDC Emergency Twitter account
http://twitter.com/cdcemergency

• Haiti Disaster Volunteering
http://www.cidi.org/incident/haiti-10a/
________________________________________
Links to non-Federal organizations are provided solely as a service to our users. Links do not constitute an endorsement of any organization by CDC or the Federal Government, and none should be inferred. The CDC is not responsible for the content of the individual organizations.
Please send us your feedback or comments: http://www.cdc.gov/flu/coca/feedback.htm.
Our Clinician Communication Team is committed to excellence in reporting our weekly updates. Please e-mail coca@cdc.gov should you note any written errors or discrepancies.

If you need further information or technical help, please send an e-mail message to: coca@cdc.gov.

Update on the Prescription Origin Code

Concerns have been communicated by NASPA to CMS – but they wanted to provide you with the background NCPDP guidance highlighted below that may help you answer questions your pharmacies may be contacting you about prescription origin code.

CMS requires origin code for NEW prescription claims after 1/1/10. The issue that pharmacies are encountering are that some plans requiring origin codes on all Rxs and not just new Rxs AND there is a lack of consistency is how codes are to be submitted for refills and transferred prescriptions..

For example:

One plan instructs for or refills and transfers
The value 0 is acceptable value for renewals and refills if the pharmacy cannot determine how the prescriber initially submitted the prescription. A blank/no entry in the field will be considered valid if the refill prescription is transmitted as a refill prescription only.
And yet, another plan the claim will reject if ANY claim comes through as blank or zero

The challenge is not only in figuring out how to bill differently for different plans, but MORE so upon AUDIT for claims submitted incorrectly (according to plan provider manual requirement) and any audit consequences.

While it doesn’t address the plan requirement variation and/or the issue of requiring origin code on refills, the guidance below and in particular the Q/A may be useful to answer some of your pharmacies questions.

“Please see the NCPDP Telecommunication Version 5 Questions, Answers, and Editorial Updates, available on the NCPDP website to any interested party. http://www.ncpdp.org/public_documents.aspx#v5ed The version dated November 2009 is available. Specifically see section 15.12 Electronic Prescribing and Prescription Origin Code (419-DJ) and its subsections for guidance on the use of the Prescription Origin Code for CMS requirements. This document is updated usually on a quarterly basis, so please check back for updates.” Currently this information is on page 168-170.

CMS Delays Ban on Faxed Prescriptions
Deadline Moved to Jan. 1, 2012
Physicians who participate in Medicare and depend on computer-generated faxes to transmit prescriptions to pharmacies can breathe a collective sigh of relief. CMS has extended its deadline for banning faxed prescriptions by three years, moving the Jan. 1, 2009, deadline to Jan. 1, 2012.
The deadline change is included in the 2009 Medicare Physician Fee Schedule final rule announced by CMS on Oct. 30. According to CMS' press release, the agency reversed its position "in the interest of patient care and safety and to encourage prescribers and dispensers to adopt e-prescribing."
Although many physicians initiate prescriptions through their electronic health record, or EHR, systems, their computers actually generate a fax to the pharmacy.

Had the deadline been imposed on Jan. 1 of next year, many physicians might have reverted back to paper-based prescriptions.
E-prescribing offers proven benefits to physicians, including reductions in medication errors, a reduced call burden from pharmacies and electronic access to formulary information.

(read the CMS press release)

Medicare Fraud Strike Force Expands Operations into Brooklyn, N.Y.; Tampa, Fla.; and Baton Rouge, La.

(posted 12/16/09)  (read more)

Medicare Expands List of Covered Preventive Services to Include HIV Screening Tests

(posted 12/8/09)

The Centers for Medicare & Medicaid Services (CMS) today announced its final decision to cover Human Immunodeficiency Virus (HIV) infection screening for Medicare beneficiaries who are at increased risk for the infection, including women who are pregnant and Medicare beneficiaries of any age who voluntarily request the service. The decision is effective immediately. (read more)

Annual Inventory of Controlled Substances 680-X-3-.08
(1) Every pharmacy shall take an initial inventory of all controlled substances on hand and shall take a new inventory of all stocks of controlled substances on hand on January 15th or the alternative fixed date approved by the Board of each year following the date the initial inventory was taken.
(4) The inventory by a pharmacy must be taken either as of the opening of business or as of the closing of business. The pharmacy shall indicate on the inventory records whether the inventory was taken as of the opening of business or as of the close of business, the date the inventory was taken, followed by the person responsible for taking the inventory.
(5) In determining the number of units of each finished form of a controlled substance in a commercial container, which has been opened, the pharmacy shall do as follows:
(a) If the substance is listed in Schedule II, an exact count or measure of the contents shall be made.
(b) If the substance is listed in Schedule III, IV or V, an estimated count or measure may be made of the contents unless the container holds more than 1000 tablets or capsules in which case an exact count of the contents must be made.
Compliance Note: The yearly inventory document will be an item reviewed during a routine inspection. KEEP IT ACCESSIBLE!

HHS Strengthens HIPAA Enforcement

(posted 11/2/09)

The U.S. Department of Health and Human Services (HHS) issued an interim final rule with request for comments today to strengthen its enforcement of the rules promulgated under the Health Insurance Portability and Accountability Act (HIPAA). The Health Information Technology for Economic and Clinical Health (HITECH) Act, which was enacted as part of the American Recovery and Reinvestment Act of 2009, modified the HHS Secretary’s authority to impose civil money penalties for violations occurring after Feb. 18, 2009. These HITECH Act revisions significantly increase the penalty amounts the Secretary may impose for violations of the HIPAA rules and encourage prompt corrective action. The interim final rule with request for comments published October 30, 2009 conforms the HIPAA enforcement regulations to these revisions made by the HITECH Act. It may be viewed and commented on at: www.regulations.gov. This rulemaking will become effective on Nov. 30, 2009, and HHS will consider all comments received by Dec. 29, 2009.(read HSS press release)

Medicaid Integrity Program Provider Audit Fact Sheet
November 2008

The Deficit Reduction Act of 2005 (DRA) created the Medicaid Integrity Program (MIP) and directed the Centers for Medicare & Medicaid Services (CMS) to enter into contracts to review Medicaid provider actions, audit claims, identify overpayments, and educate providers and others on Medicaid program integrity issues. (read tip sheet)

CMS Clarifies Medicare Part D Fraud, Waste, and Abuse Training Requirement

(posted 10/16/09)

Training deadline is December 31, 2009; CMS to release FAQ shortly.

Pharmacies may continue to implement their own fraud, waste, and abuse training programs if certain conditions are met, according to clarification obtained from CMS and released by a coalition of pharmacy groups including APhA. (read more)

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News You Can Use

Red Flags Rule Enforcement Delayed Again

Moving an August 1 deadline, the Federal Trade Commission (FTC) waited until November 1, 2009 to enforce a provision of the “red flags” rule that requires pharmacies, physicians and hospitals to adopt written plans for tracking and responding to indicators of identity theft in their billing operations. The FTC has created a Web site dedicated to informing businesses about their obligations under the rule. http://www.ftc.gov/bcp/edu/microsites/redflagsrule/index.shtml


DME Accreditation Deadline Extended

President Obama signed into law legislation that will extend the accreditation requirement for pharmacies to provide durable medical equipment (DME) in the Medicare Part B program until January 1, 2010. The legislation will help ensure that Medicare beneficiaries can continue to obtain diabetic supplies, other DME products, and counseling from their trusted pharmacies and pharmacists.


Pharmacies to Begin Transmitting Prescription Origin Codes in 2010
Beginning in 2010 the Center for Medicare and Medicaid Services will require Part D plan sponsors to obtain the “Prescription Origin Code from pharmacies through the NCPDP Telecommunication Standard 8.1 option field 419 DJ and report this code through the claims processing system. While the reporting of this code is optional in 2009 it will be required for new prescriptions next year. The Prescription Origin Code is alphanumeric and ranges from 1 to 4. These codes correspond to whether a prescription arrived at the pharmacy verbally (example: telephone call in), fax, electronic or by paper. It may be likely that providers who fail to transmit the code or transmit the incorrect code may see some claims payment issues during a plan’s audit. If the prescription arrived by fax but was coded as a verbally received prescription that could possibly trigger a recoupment demand.


AL Court Reverses Drug Price Cases

On October 16, 2009 the Alabama Supreme Court reversed jury decisions awarding the state more than $274 million from three pharmaceutical companies.
The court overturned verdicts against the drugmakers AstraZeneca PLC, Novartis AG and GlaxoSmithKline PLC.
The state had accused the drug companies of manipulating prices and causing Alabama’s Medicaid program to pay too much for prescription drugs for Medicaid recipients. The court ruled 8-1 to overturn the verdicts.
More than 70 lawsuits were filed in 2005 by the state against drug companies. The state has settled its lawsuits against 16 of the drug manufacturers for more than $124 million.


Fraud, Waste, Abuse Training Update

CMS has recently clarified that pharmacies may continue to meet the FWA training rule by certifying or attesting to plans that the pharmacies have completed their own training and that recent CMS memorandums were not intended to supersede policy stated in the 2006 Medicare Manual, which permitted pharmacies to implement their own training or take the training offered by Part D plans.


Pfizer and Wyeth Become One
Pfizer Inc. announced on October 16, 2009 that it has combined operations with Wyeth following the closing of the acquisition on October 15th. Pfizer is now a more diversified health care company, with product offerings in human, animal, and consumer health, including vaccines, biologics, small molecules and nutrition across the developed and emerging markets. It has medicines in numerous growing therapeutic areas, a robust pipeline, premier scientific and manufacturing capabilities and a leading global presence.


EDS Name Change

In August 2008, Hewlett-Packard (HP) acquired EDS, claims processor for the Alabama Medicaid Program. On Wednesday, September 23, 2009 the EDS business unit of HP changed its name to HP Enterprise Services in most locations across the country and around the world.
How will that affect health care providers in Alabama? You probably won’t notice much of any change. You’ll begin to see the HP logo or the HP Enterprise Services name on correspondence. You’ll begin to receive emails from an @hp.com email address rather than an @eds.com address and you’ll hear the HP name when calling the Montgomery office.


Continuous Quality Improvement Program Required for Medicare Part D Providers

As part of Medicare Part D, all plan sponsors and their contracted entities (pharmacies) must have and maintain continuous quality improvement (CQI) programs that are designed to reduce medication errors and adverse drug interactions and improve medication use. This requirement is stated in all Part D pharmacy network contracts. We are hearing reports of more and more health plans asking their network pharmacies for documentation of the CQI plan being used. The Alabama Pharmacy Association endorses the Pharmacy Quality Commitment Program because of its low cost and superior quality. More information can be found at http://www.medicationsafety.org.

Non-Matched NDC List
As originally announced in the 2010 Call Letter, the Centers for Medicare & Medicaid Services (CMS) and the FDA have identified a list of NDCs which are not listed on the FDA’s NDC directory. This list is known as the non-matched NDC list. CMS has posted the updated CY 2010 Non-matched NDC list with national drug codes (NDCs) provided by the Food and Drug Administration (FDA), on the CMS Part D Formulary Guidance website http://www.cms.hhs.gov/PrescriptionDrugCovContra/03_RxContracting_FormularyGuidance.asp. CMS will use this updated list to establish new edits beginning on or around January 1, 2010 that will reject prescription drug event (PDE) submissions from Part D sponsors for NDCs identified on the list. These edits will only apply to PDEs with dates of service on or after January 1, 2010.
The Non-matched NDC list was developed as part of an ongoing joint initiative between CMS and FDA to increase transparency and clarity with respect to the regulatory status of marketed prescription drug products.
CMS plans to update the list at least twice during the 2010 plan year by deleting NDCs that have been registered and listed with the FDA since the fall 2009 posting of the list and removing associated PDE edits.
Removal of edits will apply both retrospectively and prospectively for all dates of service, and additional NDCs will not be added to the CY 2010 Non-matched NDC list during the 2010 plan year.
In preparation for 2010, CMS has undertaken an effort to contact numerous stakeholders, including plans, pharmacies, pharmaceutical and biological manufacturers, generic manufacturers, wholesalers, pharmacy benefit managers and repackers.
To ensure that pharmacies are dispensing NDCs which will be payable in Part D on January 1, 2010, pharmacies are strongly encouraged to contact their contracted distribution entities, particularly repackers, to verify their NDCs are properly listed on the FDA’s NDC directory.

Social Security
Beginning January 1, 2010, changes in the law will make it easier for some people to qualify for Extra Help with their Medicare prescription drug plan costs. Under the Medicare Improvements for Patients and Providers Act:
• Life Insurance Polices will no longer count as a resource; and
• The help a person receives regularly from someone else to pay for household expenses will no longer count as income.


BCBS of Alabama Retires InfoSolutions
Effective December 31, 2009, Blue Cross and Blue Shield of Alabama will retire the InfoSolutions® Medical Information Network, which was created in 1993 to give providers access to patient medical information. As emphasis in the healthcare industry continues to focus on the need for comprehensive electronic health records, BC/BS is responding by making members’ health information more readily available through multiple sources and moving away from providing stand-alone solutions. One of these sources is Surescripts®. Blue Cross has established an interface with Surescripts to provide data to support e-prescribing and medication reconciliation. The provider community can access data such as eligibility, formulary and medication history through their certified electronic medical record (EMR) or e-prescribing solution. A second source, BeHealthy.com*, allows Blue Cross members to gather and store healthcare information in a Personal Health Record (PHR) and share that information with their healthcare providers through a secure web portal. NOTE: This change will not affect ProviderAccess on www.bcbsal.com. Providers will still sign on to ProviderAccess or connect through a vendor practice management system to check claim status, view remittances, verify patient benefits and eligibility, etc. Medication history data on members will also be made available through ProviderAccess later this year.
If you have any questions regarding the retirement of the InfoSolutions Medical Information Network, call 205-220-5900 or e-mail at infosolutions@bcbsal.org.

CMS Announces Course of Action to Identify Protected Classes of Prescription Drugs
The Centers for Medicare & Medicaid Services (CMS) announced an interim final rule that makes sure beneficiaries with conditions such as epilepsy, mental illness, and depression will not be discouraged from enrolling in any Part D plan, nor experience any interruptions in their drug therapy. The public comment period for this rule closes on March 17, 2009.
In June 2005, CMS directed that Part D formularies include all or substantially all drugs in the following six drug classes: Antidepressant; Antipsychotic; Anticonvulsant; Immunosuppressant (to prevent rejection of organ transplants); Antiretroviral (for the treatment of infection by retroviruses, primarily human immunodeficiency virus (HIV); and Antineoplastic (only those chemotherapy drugs that are generally are not covered under Medicare Part B).
The interim final rule notifies Part D plans that they must continue to provide coverage of these drugs in 2010, consistent with the policy already in place.
The rule also codifies in regulation a provision of the Medicare Improvements for Patients and Providers Act (MIPPA) with respect to the identification and coverage of protected drug categories and classes under the Part D program.
For contract years 2011 and beyond, CMS plans to consider whether any modifications are necessary to the existing six classes currently protected, whether under CMS’s existing administrative authority or under MIPPA. Should CMS decide that modifications are necessary, CMS will propose these modifications through a rulemaking process that provides for meaningful public comment.
The regulation was published on Jan. 16, 2009, and may be viewed at http://www.gpoaccess.gov/fr/browse.html. Click “Go” next to where 2009 appears in the year selection box for “Back Issues (HTML Only).”


Medicare Clarifies ‘Negotiated Prices’ Under Part D

On January 6, 2009, CMS released a regulation revising Medicare’s definition of negotiated prices by requiring drug plan sponsors under Part D to use the amount paid to a pharmacy as the basis for determining cost sharing for beneficiaries and for reporting a plan’s drug costs to CMS. The negotiated prices are the costs for prescription drugs that are reached through direct negotiation between the Part D sponsor or an intermediary contracting organization such as a pharmacy benefit manager (PBM) and the pharmaceutical manufacturer. The change is effective January 1, 2010.
CMS currently allows Part D sponsors that contract with a PBM to report to the agency the amount paid to the PBM (the lock-in price) or the amount the PBM paid to the pharmacy (the pass-through price). Under the new rule, any difference between the price paid by the plan to the PBM and the price paid by the PBM to the pharmacy must be reported as an administrative cost. This requirement helps ensure that sponsors’ administrative costs are not included in the drug costs used to determine how much the beneficiary will pay, as well as reinsurance and risk corridor payments made by CMS. This will also create a uniform definition of drug costs for all Part D sponsors.
“For patients whose plan used the lock-in model, this regulation will reduce what they pay at the pharmacy counter because their copayment will no longer be based on a higher negotiated price,” said CMS Acting Administrator Kerry Weems. “The current lock-in approach also moves beneficiaries through the Part D benefit more quickly, bringing them to the ‘coverage gap’ sooner than under the pass-through pricing model.”
The May 16, 2008 proposed rule also proposed similar revisions and additions to the definition of negotiated prices under the Retiree Drug Subsidy (RDS) program. The final rule does not finalize the changes proposed for RDS, but invites comments on several policy options.
This rule also codifies earlier guidance to plan sponsors about using Best Available Evidence (BAE) to determine an enrollee’s eligibility for extra help through the Part D Low-Income Subsidy program. The BAE policy will continue to help protect low-income beneficiaries, and pharmacies, from unnecessary co-payments at the point of sale.

(Part D policy details)

(more research facts)

(additional Part D tip sheets)


WellPoint Medicare Advantage and Prescription Drug Plan Contracts Enrollment Suspended

CMS suspended marketing and enrollment for WellPoint Medicare Advantage and Prescription Drug Plan contracts, effective January 12, 2009. With these imposed sanctions, WellPoint will not be able to market several of its Medicare Advantage and Prescription Drug Plans and will not be able to enroll new beneficiaries.
Beneficiaries currently enrolled in WellPoint sponsored plans will continue to receive the same health care services and prescription drug coverage they have now. They will not lose any Medicare coverage.
Beneficiaries who have questions should first contact WellPoint. If they have additional questions, they should contact 1-800-MEDICARE or their specific plan.
Beneficiaries who have had difficulty getting services from WellPoint may have a special opportunity to enroll in a different Medicare plan.
If they would like to learn more, they should contact 1-800-MEDICARE and explain their situation. The customer service representative will explain the next steps.
WellPoint has served as the Medicare Part D Prescription Drug Program’s safety net “point-of-sale” (POS) contractor, paying claims for Low-Income Subsidy (LIS) beneficiaries that have not yet been enrolled into a Part D plan. WellPoint will continue to pay these claims under the terms of its contract with CMS. This process has been used successfully by over 100,000 LIS beneficiaries in 2008 without a problem, and we are fully confident that the POS prescription process will continue to work effectively and seamlessly for beneficiaries at the pharmacy counter.
In the past, WellPoint also has been permitted to enroll many of these individuals into one of their plans, but this activity is being suspending as part of the sanction. WellPoint will notify CMS of any beneficiaries handled through the POS process so they can be enrolled into a non-WellPoint plan in the beneficiary’s region that has a premium at or below the LIS benchmark premium amount (in other words, a zero-premium plan for individuals receiving the full subsidy.). This is consistent with the approach used in areas where WellPoint has no zero-premium plan.
Background: The sanctions were imposed because of widespread and continued failures by WellPoint to properly administer their contracts in accordance with CMS requirements. Many of these failures have been reported by WellPoint.
WellPoint’s compliance problems include but are not limited to failures in the following areas: enrollments and disenrollments; benefits administration, (including determining premiums, co-pays, administering the benefit for LIS eligibles); grievances and appeals; marketing; claims processing; coordination of benefits; billing, and meeting call center and customer service requirements.
CMS has been actively monitoring information received from the CMS Complaints Tracking Module (CTM) and from WellPoint about reports of beneficiaries who cannot access Part D drugs when they go to buy their medicines at the pharmacy counter because of system failures. This analysis is part of the risk assessment that CMS continually conducts and led to the actions taken against WellPoint. In addition, CMS has been reaching out to affected Medicare beneficiaries to make sure their problems have been satisfactorily resolved. Although new problems should be prevented due to the enrollment suspension along with active efforts by WellPoint; CMS is continuing to monitor and follow up with these issues by reaching out directly to beneficiaries.


Self-Certification for Sale of Pseudoephedrine - Training Required Yearly by DEA

Recently, pharmacists have been receiving notice from the Department of Justice concerning self certification for the sale of pseudoephedrine. This is a reminder that each pharmacy needs to do a self certification if they are selling pseudoephedrine. Information is on the DEA/Office of Diversion Control web page, which can be found at: http://www.deadiversion.usdoj.gov/meth/index.html. Scroll down on this page to find the “Required Training and Self Certification” portion. Once the training has been completed, a copy should be made of the certificate and close attention paid to the expiration date at the bottom. No renewal notices will be sent, but recertification is required as soon as the certificate expires. A copy of the certificate should be kept on file in the pharmacy. Every pharmacy will have a different date depending on the date of their original certification.

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Other Pharmacy News

HHS Delivers the Nation’s First Health Security Strategy

(posted 1/7/10) (read more)

Spending on Health Care Slows in U.S.

(posted 1/5/10) (read more)

Spoon Size Leads to Medicine Dosage Errors

(posted 1/4/10) (read more)

Pharmacy’s top 10 news stories of 2009

(posted 1/4/10) (read more)

CMS and ONC Issue Regulations Proposing a Definition of ‘Meaningful Use’ and Setting Standards for Electronic Health Record Incentive Program

(posted 12/30/09) (read more)

Despite Slow Job Market, Demand for Pharmacy Techs, PTCB Certification Rising

(posted 12/16/09)  (read more

Sebelius Statement on Benefits of Health Insurance Reform for Businesses

(posted 12/3/09)

Secretary Releases New Fact Sheet

HHS Secretary Kathleen Sebelius today highlighted the benefits of health insurance reform for businesses and released a new fact sheet regarding a recent analysis from the Congressional Budget Office. (read more)

Joint Commission, HHS Team Up in Language Access Education Effort

New video urges health care organizations to break language access barriers

(posted 11/18/09)

Amid growing concerns about racial, ethnic and language disparities in health care, The Joint Commission and the U.S. Department of Health and Human Services (HHS) Office for Civil Rights have released a video, entitled “Improving Patient-Provider Communication,” which supports language access in health care organizations. (read more)

The video streams from The Joint Commission’s Hospitals, Language, and Culture Web site at http://www.jointcommission.org/PatientSafety/HLC/. The video is also available at the Office of Civil Rights Web site at http://www.hhs.gov/ocr/civilrights/resources/specialtopics/hospitalcommunication/index.html

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