Medicaid Tamper-Resistant Prescription Requirement

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Quick Q&A for ASCP Members

Will long-term care orders/prescriptions be excluded from the tamper-resistant prescription pad requirement?

The law specifically applies to "outpatient" drugs that are in “written” form. So, from the definition of “outpatient” we know that NHs and ICF-MRs (and some other types of facilities) are not included in the requirement. And, the “written” aspect means that verbal, faxed, and electronic prescriptions are exempt. Therefore, this requirement will not impact long-term care settings as much as community settings since LTC settings do the majority of their prescription communication using faxes.

A potential sticky area for ASCP members might be assisted living facilities and group homes, which are considered "outpatient." Pharmacies might receive hard-copy prescriptions for those residents in the delivery totes rather than receiving them via fax, in which case the tamper-resistant requirement would apply. Another potential problem is the situation where a prescriber writes out the medication order on a tamper-resistant blank even though it may not be required for that patient or their setting. When that hard-copy prescription gets faxed over to the pharmacy, the copying process makes the tamper-resistant “words” darken, subsequently making the faxed copy difficult to read by pharmacy staff.

CMS released information describing what pharmacists should do if they are not sure whether a prescription meets the tamper-resistant requirements (March 28, 2008):

  • Call the prescribing practitioner to obtain verbal confirmation of the prescription and document the confirmation appropriately. (NOTE: the pharmacy does not need to speak to the prescriber directly; a nurse or administrative staff person who is authorized to act on behalf of the prescriber may confirm the prescription.)
  • Fill the prescription and obtain documentation within 72 hours. A pharmacy may fill prescriptions on an emergency basis, provided that the pharmacy obtains a compliant prescription within 72 hours after the fill date. The compliant prescription may be in the form of a written prescription on tamper-resistant paper or may be obtained by verbal communication with the prescriber, by facsimile, or by e-prescription.

State-by-State Compilation of Tamper-Resistant Prescription Pad Requirements (PDF), compiled by the National Association of Chain Drug Stores (NACDS) - March 2008

CMS Releases Two Clarifications Regarding Tamper-Resistant Prescription Pad Policy

February 1, 2008
-  Whether a provider can add a feature to a prescription to make it compliant with the requirements (e.g., using indelible ink, embossed logos, writing out quantities rather than using numbers) - to which CMS said “No.”  They reiterate that “the statute states that all written prescriptions must be “executed on a tamper-resistant pad.”
   -  Whether computer generated prescriptions printed by a provider on plain paper, including Electronic Medical Record (EMR) computer generated prescriptions, meet CMS guidance – to which CMS said, they may meet the first phase of requirements (April 1-October 1, 2008) when just one security feature is required, but prescriptions printed on plain paper likely will not be able to meet all three baseline characteristics outlined by CMS required after October 1. Therefore, beginning October 1, computer-generated prescriptions must be printed on paper that meets that requirement.

Download the PDF here (PDF).

National Council for Prescription Drug Programs (NCPDP) Sends Letter to State Medicaid Directors Suggesting Recommendations on Tamper-Resistant Prescription Requirements

February 1, 2008
NCPDP convened an industry forum and considered all the features in the three categories of tamper-resistant characteristics set forth by the Centers for Medicare and Medicaid Services (CMS). In a letter to state Medicaid Directors (PDF), they request that states implement certain features identified by pharmacy and industry representatives as the easiest to implement. In their letter, they also ask that each state incorporate, as one of their three tamper-resistant features, a listing of the security features on the actual prescription pad. NCPDP, with the support of APhA, NCPA, and NACDS, says this feature will help the pharmacist identify and verify that the prescription is indeed a tamper-resistant prescription. NCPDP and other members of the industry encouraged those states that had not yet issued guidance to publish your requirements as soon as possible so that providers have time to order new prescription pads. NCPDP also offered a depiction of a sample prescription with preferred tamper-resistant features in its letter.

Sept. 28, 2007 Update

Congress has passed a bill to extend the deadline for implementation of this Medicaid tamper-resistant prescription pad requirement to April 1, 2008!

Act Description

The U. S. Troop Readiness, Veterans’ Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007 contains a provision that requires Medicaid prescriptions to be written on "tamper-resistant" prescription pads. This provision becomes effective on October 1, 2007 unless intervention occurs to prevent this from happening.

The impact of this provision will be to prevent pharmacies from being paid for Medicaid prescriptions unless they are written on tamper-resistant prescription pads. This could serve as a deterrent to physicians caring for Medicaid recipients and, because of the very short time frame for implementation, is likely to result in Medicaid recipients not receiving prescriptions after October 1, or experiencing significant delays in obtaining them.

Legislation

Following is the legislative language:

  • "(b) Requirement for Use of Tamper-Resistant Prescription Pads Under the Medicaid Program
  • (1) IN GENERAL- Section 1903(i) of the Social Security Act (42 U.S.C. 1396b(i)) is amended-- (A) by striking 'or' at the end of paragraph (21);
  • (B) by striking the period at the end of paragraph (22) and inserting `; or'; and
  • (C) by inserting after paragraph (22) the following new paragraph:
  • (23) with respect to amounts expended for medical assistance for covered outpatient drugs (as defined in section 1927(k)(2)) for which the prescription was executed in written (and non-electronic) form unless the prescription was executed on a tamper-resistant pad.'.
  • (2) EFFECTIVE DATE- The amendments made by paragraph (1) shall apply to prescriptions executed after September 30, 2007."

Regulatory Activity

The Centers for Medicare & Medicaid Services issued a letter to State Medicaid Program Directors (PDF) on August 20, 2007, to provide guidance on implementation of the legislative requirement for tamper-resistant prescription pads for Medicaid prescriptions. CMS also provided a one-page background paper (PDF) on this subject.

State Medicaid programs are beginning to release specific guidance about how the legislation will be implemented in each state. There is considerable variation in how states are interpreting and applying the legislation and CMS guidance. Because numerous questions remain unanswered about this legislation, CMS has prepared a Question and Answer document (PDF).

What we do know now is that certain prescriptions are exempt from the tamper-resistant prescription requirement. These include prescription orders communicated by telephone, facsimile, or electronic means. The impact of this requirement on nursing facilities, therefore, is expected to be minimal. Assisted living may be impacted more heavily, depending upon the staffing and operations practices of the ALF and the pharmacy serving the ALF.

Related and Background Information

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