Many pharmacists have received the following communication that must be completed for contract renewal. While some of the items below appear reasonable, some are not. Some of the requests make no sense and one wonders what value the responses are to CVS/Caremark. The requests are printed below.

Thank you for your CVS credentialing submission. Based on the answers you provided, please reply to this email, attaching the following documentation and including your store name and NCPDP number.

• Provide copies of all state Board of Pharmacy licenses.
• Provide copies of all business licenses.
• Provide the evidence for the last time your pharmacy submitted to each state's Prescription Monitoring Program (every state where your pharmacy is licensed).
• Provide all Board of Pharmacy inspections for each state where your pharmacy is licensed in the past 24 months.
• Provide your pharmacy's Certificate of Analysis P&P or SOP.
• Provide the PCAB accreditation if your pharmacy compounds use Active Pharmaceutical Ingredients (API) or manipulations of tablets (crushing, dissolving, etc).
• Provide a P&P indicating how the pharmacy compound that contains a combination of 3 or more ingredients with NDC or API codes on the compounding practice.
• Provide your pharmacy's list of the API approved vendor(s) where the pharmacy purchases APIs to include the past 30 days of invoices.
• Disclose all owners, investors, shareholders and their corresponding professions and all licenses and/or registrations including identification and expiration dates. Provide percentage of ownership stake for each licensed professional.
• Provide one study supported by compendial listing of IIb, B or higher that supports the clinical/therapeutic value for each compound ingredient of your pharmacy's top 10 compounds, as well as any compounds for which you provide prescribers with pre-printed prescription pads, or promote via sales efforts to patients and/or physicians.
• Provide one study supported by compendial listing of IIb, B or higher that supports the stability, safety and efficacy for each compound ingredient in each compound of your pharmacy's top 10 compounded products, as well as any compounds for which you provide prescribers with pre-printed prescription pads, or promote via sales efforts to patients and/or physicians.
• Provide a list of all states your pharmacy practices pharmacy by shipping, delivering, mailing, or forms of delivery such as but not limited to (courier, USPS, FedEx, UPS, etc.) compound medications?
• Provide a detailed floor plan for your pharmacy including room function, approximate square feet, and what the space is used by general public, pharmacy licensed staff, and/or non-licensed staff (include pictures).
• All marketing materials related to compounding, including materials for specific compound preparations.
• Policy and Procedures for Anti-Kickback Statute.
• Policy and Procedures for USP 795 compliance.
• Standard Operating Procedures for each type of compounding your pharmacy performs.
• Policy and Procedures for accessing MSDS sheets.
• Policy and Procedures for submitting a Usual and Customary (U&C) price.
• Copy of any accreditation (URAC, AHCA, etc.).
• Policy and Procedures for the pharmacy's private patient consultation room.

Questions about this may include the following:

1. How are the responses going to be graded?
2. What is a "passing" score?
3. "Who and How" is it decided what is appropriate in light of current standards, regulations and laws?
4. What recourse does a pharmacy have if it "fails"?
5. Is there no concern for the patients that are paying in premiums but must make-do with non-individualized or alternate medications?

As I stated last week in the "Did You Know?" portion of this newsletter:

"THIS SYSTEM IS BROKEN!"

Patients can't get the medications they have paid for. Meanwhile, patients suffer�physicians can't prescribe what is needed�and the greed at the PBMs goes on and on! This seems like another exercise for CVS/Caremark to keep other peoples' money! Million-dollar salaries and skyboxes anyone?

News

Hospira Recalling One Lot of 0.9% Sodium Chloride Injection Due to Particulate Matter (Human Hair)
Hospira is initiating a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection USP, 250 mL (NDC 0409-7983-02, Lot 44-002-JT, Expiry 1AUG2016) to the user level due to a confirmed customer report of particulate in a single unit; identified as a human hair sealed in the bag at the additive port area. If the particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response.
http://www.fda.gov/Safety/Recalls/ucm430929.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

New Pharmacy School for Miami
Plans to open a new pharmacy school in Miami were just revealed by Larkin Community Hospital in Florida. Miami Today states that the school will open in September 2016 in a building the hospital recently purchased for $5.5 million. The school is expected to enroll 100 students. The proposed school will be part of a health-sciences campus in Homestead that will include a nursing school, biomedical sciences college, medical college, and dentistry college. Also, the campus will include a magnet middle school and a high school in hopes of attracting minorities from the Miami area into healthcare professions.
http://drugtopics.modernmedicine.com/drug-topics/news/new-pharmacy-school-planned-miami

OIG Requests Greater CMS Oversight of Compounded Drugs
The Office of Inspector General made two recommendations on the topic of oversight of compounded sterile preparations (CSPs) in hospitals. They state that Medicare-approved hospital accreditors still don't properly oversee contracts hospitals have with compounding pharmacies to assure these drugs are safe. A report from 2013 shows that 92% of hospitals use CSPs, and 80% contract with at least one standalone pharmacy for their supplies. The OIG made two overarching recommendations and CMS agreed with both:

1. Ensure that hospital surveyors receive training on standards from nationally recognized organizations related to safe-compounding practices
2. Amend the interpretive guidelines to address hospitals' contracts with standalone compounding pharmacies

http://www.healthleadersmedia.com/page-2/QUA-312515/OIG-Raps-CMS-Oversight-of-Compounded-Drugs

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Did You Know ...

...that one's actions speak so loud, it's hard to hear what they're saying?

Tip of the Week

When the truth is not required, one has no basis upon which to make good decisions, including personal, family, business, and others.

Looking Back

His beard was long,
And strong and tough.
He lost his
Chicken in the rough!
     Burma Shave

ACHC is pleased to announce that the following pharmacies have achieved PCAB Accreditation:

ProMed Pharmacy, Inc., East Meadow, NY; Saira Ahmed, PharmD, saira@promedpharmacy.com. Initial Accreditation for Non-Sterile Compounding

Valley View Drugs, Inc., La Mirada, CA; David Whitehouse, RPh, dwhitehouse@valleyviewdrugs.com. Initial Accreditation for Non-Sterile Compounding

Prime Pharmacy Solutions, LLC, Slidell, LA; Joseph Pierre, PharmD, trey@primepharmacysolutions.com. Initial Accreditation for Non-Sterile Compounding

Insight Pharmacy, Havertown, PA; Young Gim, PharmD, insightpharmacy@gmail.com. Initial Accreditation for Non-Sterile Compounding

Compound Pharmaceutical Technologies, Inc., Daphne, AL; John Hart, johnhart@cptinc.org. Re-Accreditation for Non-Sterile Compounding

District Drugs & Compounding Center Ltd., Rock Island, IL; Jim Perry, RPh, jperry@districtdrugs.com. Re-Accreditation for Sterile and Non-Sterile Compounding

Island Compounding Pharmacy, Grosse Ile, MI; Laura Lile, MD, RPh, pharmacy@islandmedicalpractice.net. Initial Accreditation for Non-Sterile Compounding

US Compounding, Conway, AR; Rebecca Mitchell, PharmD, bmitchell@uscompounding.com. Re-Accreditation for Sterile and Non-Sterile Compounding

Thrive Rx Specialty Pharmacy Corporation, dba Mydrexa Compounding Pharmacy, Poway, CA; Maryna Blom, RPh, marynablom@gmail.com. Initial Accreditation for Non-Sterile Compounding

Lee's Pharmacy North, McAllen, TX; John Calvillo, PharmD, johnpaulcalvillo@hotmail.com. Initial Accreditation for Non-Sterile Compounding

Health & Wellness Compounding Pharmacy, Nashville, TN; Mark Binkley, DPh, mbinkley@myhwcp.com. Initial Accreditation for Sterile and Non-Sterile Compounding

Cure Rx Pharmacy, Los Angeles, CA; Phil Ettedgui, PharmD, curerxpharmacy@gmail.com. Initial Accreditation for Non-Sterile Compounding

The Wellness Center Pharmacy, Inc., dba Designer Drugs, Chattanooga, TN; Randy Davis, DPh, randyd@compound-rx.com. Re-Accreditation for Sterile and Non-Sterile Compounding

Village Apothecary, Lake Katrine, NY; Neal Smoller, PharmD, nsmoller@gmail.com. Re-Accreditation for Non-Sterile Compounding

IV Specialty, Ltd., Austin, TX; Carlos Garcia, PharmD, Carlosg@ivspecialty.com. Initial Accreditation for Sterile Compounding

Wellness Compounding Pharmacy, Medford, OR; Angie Meeker, PharmD, angiem@dermali.com. Re-Accreditation for Non-Sterile Compounding

• Efficacy and Clinical Value of Commonly Compounded Hormone Replacement Therapy: A Literature Review
• Giving Back: A Win-Win Plan of Action for Compounding Pharmacists
• Pharmacy Student's Survey: Perceptions and Expectations of Pharmaceutical Compounding
• Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: Science and Compliance
• Biotechnology, Nanotechnology, and Pharmacogenomics and Pharmaceutical Compounding, Part 1
• Quality Control: Refractive Index
• Basics of Sterile Compounding: Aseptic Processing
• Basics of Compounding: The Revised "Not to Compound List"
• Stability Assessment of Repackaged Bevacizumab for Intravitreal Administration
• Physicochemical and Microbiological Stability of Azathioprine in InOrpha Suspending Agent Studied Under Various Conditions
• Stability of Suspensions: Theoretical and Practical Considerations before Compounding
• Formulations for Compounding
• Departments: Prescription; Calculations; Postscription

Contact IJPC at 800-757-4572 or www.ijpc.com for a subscription.