December Legislative Update: Tech Leg, E-Prescribing, Adverse Event Reporting, FWA Training
Pharmacy Technician Legislation
SB 203, the Pharmacy Technician bill sponsored by Sen. Tim Grendell, had sponsor testimony along with proponent and opponent testimony in November. The bill passed the House Health Committee on December 10 and is scheduled for a vote by the full House on Tuesday, December 16. Watch OPA's Pharmacist's Legislative Status Report for updates.
CMS Extends the Electronic Prescribing Exemption for Computer- Generated Facsimiles
CMS (Centers for Medicare and Medicaid Services) received considerable feedback from pharmacists and others regarding the economic and workflow impact of removing the computer-generated fax exemption. After careful consideration of this feedback, and coupled with the new incentives for prescribers provided in the Medicare Improvements for Patients and Providers Act, CMS has reconsidered the electronic prescribing exemption for computer- generated facsimiles. In the interest of patient care and safety, and to encourage prescribers and dispensers to adopt e-prescribing, CMS is extending the electronic prescribing exemption for computer-generated faxes until January 1, 2012.
FDA Final Rule Delaying Compliance Deadline of 800 Number for Adverse Event Reporting until July 1
The Food and Drug Administration (FDA) has issued a final rule regarding the toll-free number for reporting adverse events on labeling. This final rule delays the original compliance date of January 1, 2009 to July 1, 2009 to allow additional time for implementation.
This rule requires pharmacists and other authorized dispensers to distribute the 1-800 number side effects statement to consumers with prescription medications. The prescription labeling must include the statement, "Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088." The side effects statement may be distributed in one of five ways:
1. on a sticker attached to the unit package, vial, or container of the drug product;
2. on a pre-printed prescription vial cap;
3. on a separate sheet of paper;
4. in consumer medication information; or
5. in the appropriate FDA-approved Medication Guide that contains the side effects statement.
The easiest way for pharmacists who distribute information leaflets with all prescriptions (known as consumer medication information or CMI) is to have the statement included on each of the sheets. According to FDA, you are NOT allowed to just preprint the message on the prescription bag. Be sure you find a way to comply by July 1.
With regard to OTC products, the manufacturer must comply. Manufacturers and distributors of affected OTC products who do not already include the manufacturer's contact information must either include a 1-800 number to contact the manufacturer or
FDA' s OTC side effect statement in the warnings' section of the drug facts format labeling. FDA's OTC side effect statement is, "Stop use and ask a doctor if side effects occur. You may report side effects to FDA at 1.800.FDA.1088."
CMS Clarifies Requirement for Medicare Part D Fraud, Waste, and Abuse Training Requirements
The Medicare Modernization Act (MMA) requires that Medicare Advantage (MA) organizations and Medicare Part D plan sponsors provide their first tier, downstream, and related contracting entities (such as pharmacies) with appropriate fraud, waste and abuse training. Plan sponsors are responsible for ensuring that all employees (including managers and directors) and downstream/contracting entities are provided appropriate training on an annual basis. Due to the increasing number of questions that CMS received on this issue and recognizing that the requirement could be cumbersome for entities that contract with multiple plan sponsors, CMS issued additional clarification. The annual training requirement becomes effective January 1, 2009, but does not have to be completed until December 31, 2009. CMS noted that it is working with associations to develop a training program that meets CMS' requirements so that entities would only have to take this training once a year. Specifically, the one training would satisfy the CMS requirement for all MA organizations and Medicare Part D plan sponsors with which an entity is affiliated, alleviating the potential need for entities to have multiple trainings from different plan sponsors each year. CMS hopes to have the training materials available soon. Until that time, plan sponsors are still responsible for either providing the training directly or providing the appropriate materials to ensure that the training is taken. More fraud and abuse training requirement information is available on CMS' website www.cms.hhs.gov.
What is the OIG Exclusions List?
OPA is encouraging members to become familiar with the U.S. Office of Inspector General's (OIG) Exclusion List. The list, which can be found on the OIG website at http://www.oig.hhs.gov/fraud/exclusions/exclusions_list.asp, contains names of providers who have been excluded from participation in federally-funded health care programs. Providers are included on the list for a variety of reasons, depending on their state law. Potential reasons can include substance abuse, overprescribing or self-prescribing, stealing medications, or even defaulting on student loans. Pharmacy owners should consult the exclusions list frequently and especially before hiring a pharmacist or pharmacy staff person to be sure that they are not included on the list. Consequences of hiring a provider who is on the exclusions list include a $10,000 fine for each prescription dispensed or prepared by an excluded pharmacist or pharmacy staffer. Members of Congress have been approached to address the lack of discretion that the OIG has in determining who should be included on the exclusions list and for what period of time.
Ohio Medicaid turned on the NPI number edit later than planned, November 1. OPA has received phone calls from quite a few pharmacists whose claims are not going through. Here is what you should do immediately to solve this problem: Send a fax to Margaret Scott, ODJFS, at 614.466.2908, with a copy of the NPI enumerator letter, or email the same to Medicaid_pharmacy@jfs.ohio.gov. Hopefully, the claims should begin to be paid within five days.
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