February Legislative Update: Gov Signs Tech Leg, Name Tag Rule, CMS Surety Bond Rule, Requirements for DMEPOS

Pharmacy Technician Legislation Signed by Governor
SB 203, the Pharmacy Technician legislation, was signed into law by Governor Strickland on Wednesday, January 7, 2009.  SB 203 will become effective April 7, 2009.  The Board of Pharmacy and the Pharmacy Technician Rules Committee are in the process of formulating rules. Many details will be worked out during the writing of these rules, so we will be watching the process closely. When the rules are released for public comment, OPA members will be able to access them through our website. The following is a summary of the key points of the new legislation.

Qualified pharmacy technician means a person whom, under the direct supervision of a pharmacist, all of the following apply:

• The person is 18 years of age or older
• Possesses a high school diploma or GED
• Passes a criminal records' check (has no felony convictions ) that is submitted to the employer
• Passes a competency exam approved in rule by the Ohio Board of Pharmacy (BOP).

Several caveats to these requirements exist:

• High school students enrolled in a pharmacy technician program offered at a joint vocational school approved by the Ohio Department of Education are excluded from the age requirement, but must pass a competency exam approved in rule by the Ohio Board of Pharmacy within 210 days of graduation.
• People employed as pharmacy technicians on the effective date of the bill who do not possess a high school diploma or GED are "grandfathered."
• New-hires and pharmacy techs employed by an employer for fewer than five years must submit to the criminal records' check.
• Those employed as pharmacy technicians on the effective date of the bill have one year from that date to pass a BOP-approved competency exam (Board will need time to promulgate rules in that regard).
• New-hires will have 210 days from the date of hire to pass a BOP-approved competency exam.

What does SB 203 allow a qualified pharmacy technician to do?

In a pharmacy or while performing a function of the pharmacy and under the direct supervision of a pharmacist, a qualified pharmacy technician may do any of the following:

• a. engage in the compounding of any drugs
• b. package or label any medication
• c. prepare or mix any intravenous medication to be injected into a human being

A pharmacy technician who has not yet passed a BOP-approved competency exam to become a qualified pharmacy technician may work in that capacity as long as he/she has completed a training program that meets criteria established in rule by the BOP.  (The BOP will state what constitutes an acceptable training program and employer-sponsored training programs will have to meet those criteria.)

Anyone convicted of violating these provisions or permitting these violations to occur is guilty of a second degree misdemeanor for the first offense, a first degree misdemeanor for the second offense, and a fifth degree felony for the third offense.        

New Pharmacy Board Rule on Employee Name Tags
The Board of Pharmacy recently enacted a rule, 4729-9-02 (G), regarding employee name tags.  As of January 1, 2009, any employee who has contact with the general public must wear a name tag that includes the employee's job title.  This language was originally part of SB 203, the Pharmacy Technician bill, but was removed and resurfaced in Administrative Rule.  This is apparently in response to concerns raised by the public that they are talking to numerous people behind the pharmacy counter and, without name tags, they aren't sure with whom they are talking.

CMS Releases Final Rule for Surety Bond Requirements for DMEPOS Suppliers
On January 2, 2009, CMS released its final rule on surety bond liability coverage requirements for Medicare durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) suppliers (including pharmacies). By October 2, 2009, Medicare-enrolled DMEPOS suppliers must have purchased a surety bond (minimum $50,000) for each National Provider Identifier (NPI) to which Medicare has granted billing privileges. Beginning May 4, 2009, DMEPOS suppliers seeking to enroll or to change the ownership of a DMEPOS supplier must purchase a surety bond for each assigned NPI for which the DMEPOS supplier (the pharmacy) is seeking to obtain billing privileges.  OPA strongly opposes this new requirement, and we are working closely with Sen. Sherrod Brown, Sen. George Voinovich and Rep. Charlie Wilson to exempt pharmacists from this expensive and unnecessary requirement.  View entire rule.

 AMP Injunction Anniversary
The AMP rule injunction is one-year-old. December 19, 2008 marked the anniversary of the legal victory in a lawsuit National Community Pharmacists Association (NCPA) and the National Association of Chain Drug Stores (NACDS) filed to block implementation of an AMP-based federal Medicaid rule. If implemented, it would slash generic drug reimbursements well below pharmacy acquisition costs.

 It is estimated that the injunction delay has saved the average independent community pharmacy $208 a day or about $76,000, and counting. The next hearing on the injunction is scheduled for February 25, 2009 in U.S. District Court. Congress last year passed an implementation delay as well, which expires September 30, 2009.

Since both delays are temporary, it is vitally important that we find a permanent, fair reimbursement method not based on Average Manufacturer Price (AMP), one that allows pharmacies to remain open and preserves patient access to community pharmacies.

 If you have any questions or comments about the issues mentioned in this article, please contact Kelly Vyzral, Director of Government Affairs, at 614.586.1497 or kvyzral@ohiopharmacists.org.