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Capitol Connections September 14, 2012
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September 14, 2012


IACP Submits Comments to CMS on Equality in Billing of “Prepared Drugs”

For more than a year, IACP’s Work Group on Centers for Medicare and Medicaid Services (CMS) Billing Issues has developed positions and policies for the Academy’s Board of Directors on how pharmacies are supposed to submit bills for “prepared drugs” compounded and dispensed incident-to a billable physician service.  Last week, your Academy submitted formal comments to proposed rules issued by the agency.

According to the agency, only physicians who administer a medication in their offices are permitted to directly bill or be reimbursed for those products.  Where that impacts pharmacists – and compounders especially – is when a medicine is prepared by the pharmacy but administered in the physician’s office.  According to CMS, the pharmacy should only bill and receive payment for those preparations from the prescriber and not CMS directly.

At the heart of the issue is a serious inconsistency in CMS’ policy and its enforcement of that position.  Some of the regional carriers – the companies hired by CMS to process Medicare billings -- have accepted and paid for direct pharmacy billings for “prepared drugs.”  Other carriers around the country have not.  That has created an unlevel playing field for pharmacies that are unable to compete equitably in the marketplace.  Some pharmacies regions with carriers that pay directly have used that as a marketing tool to secure business from other pharmacies.

“IACP has looked at this imbalance cause by CMS and tried to find the right middle-ground,” says IACP Immediate Past President John Herr, RPh, FIACP.  “The difficulty is that we have some members who are helped and some who are harmed by the agency’s failure to solve the problem of their own making.  In preparing our comments, we focused on how this will be resolved now and prevented in the future rather than saying that one group is right and one group is wrong.” 

“This issue will not be fixed any time soon,” says IACP Vice-President of Government Affairs Sarah Dodge.  “At a minimum, CMS will take several months to read through all the comments on this important compounding issue before it makes any further decision.  Plus, we have to understand that our issue is but three pages within a much larger rule making publication which affects everything from this problem to the new reimbursement structure for physicians.”

As things develop IACP will continue to update you on our efforts to secure fair treatment for compounders by public and private payers.

Have you Received a Letter from Genentech?

IACP Members have reported receiving a letter this week from Genentech, terminating their product agreement.  Click here to view letter. Have you received this letter? Please let your Academy know so we can determine if this is an isolated occurrence of if this is a widespread campaign. Please email and let us know if you’ve received this Genentech letter.

Requesting NABP e-Profile ID and Birth Date!

Pharmacists and pharmacy technicians are now required to submit their NABP e-Profile ID and birth date to receive credit for any ACPE-accredited CPE session. The new electronic system, CPE Monitor, will now track completed CPE credits online for pharmacists and pharmacy technicians. Please click here to register for your NABP e-Profile ID. You will be asked for your NABP e-Profile ID and birth date when registering for IACP Continuing Education events.

To make sure you receive your IACP Continuing Education Credits, please take a moment to log into the IACP Member Center and update your membership profile with your NABP e-Profile ID and birth date. It is the responsibility of the CPE taker to give IACP correct information.  If incorrect information is provided, the record will be rejected by CPE Monitor and the CPE credit will not be awarded.


For more information about the new CPE Monitor Service, please click here. If you have any questions, please email Michelle Greene or call the IACP office at (281) 933-8400.

DEA Interpretation of “Agent of Physician” and Prescriptions

If you’re not careful, the Drug Enforcement Administration’s (DEA) current interpretation of “agent of physician” under the Controlled Substances Act (CSA) and how your pharmacy handles prescriptions could cost you millions of dollars in penalties and fines. Here’s how:

Current DEA guidance mandates that faxing prescribers for refills of controlled substance prescription renewals is in violation of Federal Law 21 C'FR 1306.04(a) and 1306.05(0. This is because most pharmacy computer software systems pre-populate fields allowing the prescriber to simply fill in a few blanks, date and sign the request. Federal Law states that since pharmacists are not agents of the prescriber, this type of renewal prescription request for prescribers is illegal.

IACP suggests considering the following when accepting prescriptions containing controlled dangerous substance (CDS) ingredients. Click here to view article in its entirety.

FDA Prohibits Florida Compounding Pharmacy from Repacking Avastin®

Last week, the Food and Drug Administration (FDA) instructed a compounding pharmacy in Hollywood, Fla. to stop repacking Avastin® after it was confirmed that syringes from the facility were contaminated and ultimately the source of infection for some patients.

During a search, FDA inspectors discovered that the pharmacy did not have established procedures for sterile compounding. It was also determined that employees were not properly trained to handle such preparations. Click here to view story.

IACP urges its members to keep the following guidelines in mind when compounding sterile preparations. Click here for IACP's Recommended Guidelines and Resources on Sterile Compounded Preparations.

Are you confident that your pharmacy practice is following proper protocol and procedures? Maybe you need a refresher course on current regulations. IACP’s on-demand webinar series “Safely Compounding Quality Medications - A Review of Revised USP General Chapter <795>”, presented by IACP Member and USO Compounding Committee Expert Linda F. McElhiney, PharmD, RPh, FIACP, FASHP, is the perfect solution. To register or for more information about IACP AdvanCE webinars, click here.

A Little Due Diligence Can Go a Long Way featured an insightful article that explored the lack of oversight among Chinese drug companies claiming to produce quality active pharmaceutical ingredients (API) that are available on the open market worldwide. Click here to view story.

In an effort to aid IACP Members in avoiding the pitfalls of dealing with rogue drug companies your Academy released API supplier information in the last issue of Capitol Connections. Click here to view IACP’s “API Supplier-Did You Know?”

IACP Calendar

Click here to view IACP’s Upcoming Events.




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