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Legislative Update February 2008

Kelly Vzyral, Director of Government Affairs

Court Blocks AMP Implementation
U.S. District Court Judge granted a temporary restraining order in the lawsuit brought by NCPA and NACDS against CMS and its final rule using AMP as the basis for Medicaid generic drug reimbursement. The judge's ruling means that CMS cannot implement the AMP rule as currently written and must start the rulemaking process over. We are not sure how long that will take.

The judge found "irreparable harm" to community pharmacies and a likelihood of success on the merits of the lawsuit, both of which are required for an injunction. The injunction stated that it was "crystal clear" that CMS had violated the law, the Deficit Reduction Act.

The injunction also stated that CMS's AMP definition violated the plain language of the law and was "A WHOLESALE REWRITE" of what the Congress had mandated. We hope that CMS uses the redrafting process to make the next final rule far less onerous on community pharmacy, one that will not handicap community pharmacies by paying them substantially below their acquisition costs.

Keep in mind that language that OPA worked to have included in the Ohio budget will hold pharmacies harmless in the event that the AMP pays below acquisition cost.

FDA Clarifies Use of 1-800 Number for Reporting Side Effects
As of the beginning of 2009, pharmacies to add toll-free number to medication labels.

Beginning January 1, 2009, pharmacies must include a 1-800 number for reporting adverse events on the labeling of new and refill prescription and OTC products dispensed in an outpatient setting. The rule was designed to codify the proposed rule titled, "Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products" (April 22, 2004) that, under the FDA Amendments Act of 2007 (FDAAA), became effective on January 1, 2008. Although the requirement officially took effect January 1, 2008, FDA acknowledged that pharmacies, manufacturers, and vendors will need time to comply, and to that end will give them one year to reach compliance.

The rule requires that labeling contain a 1-800 number for reporting adverse events, but not for obtaining medical advice. The interim final rule does not apply to OTCs if their product packaging already includes a toll-free number for reporting complaints to the manufacturer or distributor.

The required labeling is referred to as the "side effects statement." For OTC products whose packaging does not include a toll-free number through which consumers can report complaints to the manufacturer or distributor of the drug product, the required labeling is: "Side effects may occur. You may report side effects to FDA at 1-800-FDA-1088." For prescription drug products, the side effects statement must read: "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088."

Pharmacists and other authorized dispensers may distribute this "side effects" statement in one of five ways:

  • On a sticker attached to the unit package, vial, or container of the drug product
  • On a preprinted pharmacy prescription vial cap
  • On a separate sheet of paper
  • In consumer medication information
  • In the appropriate FDA-approved Medication Guide that contains the statement

Although this provision will not be enforced until January 1, 2009, FDA will still publish the final rule at the end of this year, based on its ongoing research and comments received on the proposed rule.

CMS Announces Accreditation Deadlines for DMEPOS Suppliers
Section 302 of the Medicare Modernization Act (the Act) required the Secretary to establish and implement quality standards for suppliers of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS). All suppliers that furnish these covered items must comply with the quality standards in order to receive Medicare Part B payments and to retain a supplier billing number. Covered items include DME; medical supplies; home dialysis supplies and equipment; therapeutic shoes; parenteral and enteral nutrient equipment and supplies; transfusion medicine; and prosthetic devices, prosthetics, and orthotics. The deadlines for accreditation are as follows:

  • Existing DMEPOS suppliers enrolled in the Medicare program are required to obtain and submit an approved accreditation to the National Supplier Clearinghouse (NSC) by September 30, 2009.
  • New DMEPOS suppliers who are enrolled for the first time before March 1, 2008 must obtain and submit an approved accreditation to the NSC by January 1, 2009.
  • New DMEPOS suppliers submitting an enrollment application to the NSC on or after March 1, 2008 must be accredited prior to submitting the application.

Please note that the NSC shall revoke a DMEPOS supplier's billing privileges if the supplier fails to obtain and submit supporting documentation that they are accredited. For more information, please visit

Medication Therapy Management Opportunities Available in Ohio
Pharmacies in Ohio have the opportunity to participate in the Community Care Rx (CCRx) MTM Services Program, which is available through a company called Mirixa. This program affords your pharmacy the opportunity to be compensated for providing MTM services that will positively impact your patients' quality of life and possibly reduce their healthcare costs.

To participate in, receive training for, or simply learn more about this program, contact Mirixa at 703.683.1955 or visit  In order to sign up for this program, you must fill out a contract with CCRx and Mirixa. Both contracts are available on the website listed above.

CCRx also offers a billable service known as the Welcome to CCRx Medication Reviews: Helping Your Patients Transition into CCRx. Beneficiaries who enroll in CCRx are eligible for the Welcome to CCRx Medication Review. The Welcome Review is a review of all of the patient's medications that will be conducted face-to-face with the patient's pharmacist. Because the Welcome Review is part of the CCRx transition process, the service is offered to beneficiaries free of charge and is voluntary.

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


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