Capitol Hill Notifications
Subject: Delay in Requirement to Use Tamper-Resistant Prescription Pads under Medicaid
On Saturday, September 29, 2007, The President signed into law the "TMA, Abstinence Education, and QI Programs Extension Act of 2007" (P.L. 110-90), delaying the implementation date for the requirement that all paper Medicaid prescriptions to be written on tamper-resistant paper. Under the new law, as of April 1, 2008, all written Medicaid prescriptions must be on tamper-resistant prescription pads.
CMS' guidance on the tamper-resistant law, set forth in an August 17, 2007 State Medicaid Director letter, contains two phases. For the first, a prescription must contain at least one of the three tamper-resistant characteristics in order to be considered "tamper resistant." For the second, prescriptions must contain all three characteristics.
The two-phased approach will still be in effect. At least one of the three tamper-resistant characteristics is required on April 1, 2008. All three characteristics are required on October 1, 2008.
All other guidance that CMS has issued on this requirement contained in the State Medicaid Director letter and Frequently Asked Questions will still apply once it is implemented.
Medicaid Tamper-Resistant Prescription Information for State Health Policymakers
Starting on October 1, 2007, in order for Medicaid outpatient drugs to be reimbursable by the federal government, all written, non-electronic prescriptions must be executed on tamper-resistant pads. This requirement was included in section 7002(b) of the U.S. Troop Readiness, Veterans' Care, Katrina Recover, and Iraq Accountability Appropriations Act of 2007. On August 17, 2007, the Centers for Medicare & Medicaid Services (CMS), issued a letter to State Medicaid Directors with guidance on implementing the new requirement.
CMS has outlined three baseline characteristics of tamper-resistant prescription pads, but each State will define which features it will require to meet those characteristics in order to be considered tamper-resistant. The baseline characteristics must:
- Prevent unauthorized copying of a completed or blank prescription form
- Prevent the erasure or modification of information written on the prescription by the prescriber
- Prevent the use of counterfeit prescription forms
By October 1, 2007, States must require at least one of these baseline requirements. By October 1, 2008, States must require all three characteristics on prescription pads in order to be considered tamper-resistant.
The letter to the State Medicaid Directors outlines situations where the new requirement does and does not apply. The requirement does not apply: when the prescription is communicated by the prescriber to the pharmacy electronically, verbally, or by fax; a managed care entity pays for the prescription; or in most situations when drugs are provided in certain institutional and clinical facilities. The letter also allows emergency fills as long as a prescriber provides a verbal, faxed, electronic, or compliant written prescription within 72 hours. For detailed information on the requirements, please refer to the State Medicaid Director letter.
What to think about to begin
States may need to act quickly to implement this requirement by October 1, 2007. To prepare for implementation, State health policymakers should begin by asking the following questions:
- Does your State already have rules that require some prescriptions to be tamper-resistant? If so, do those rules meet or can they be expanded to meet the requirements outlined by CMS?
- Will your State need to pass legislation or make regulator changes to its Medicaid pharmacy reimbursement procedures?
- Does your State have an e-prescribing initiative? Electronic, faxed, and verbal prescriptions do not need tamper-resistant prescription pads.
- Will your State supply providers with tamper-resistant prescription pads that comply with the State's requirements? If not, will your State identify suppliers of tamper-resistant prescription pads that comply with the State's requirements for providers?
- Can your State apply model practices from States that already require tamper-resistant prescription pads?
- How will your State communicate this new requirement to pharmacists and prescribers?
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Frequently asked questions concerning the tamper-resistant prescription pad law
Section 7002(b) of the U.S. Troop Readiness Veterans' Care, Katrina Recover, and Iraq Accountability Appropriations Act of 2007
Effective Date of the New Law (Section 7002(b))
Q: Will the Centers for Medicare & Medicaid Services (CMS)delay the October 1, 2007 effective date of section 7002(b)?
A: No. Section 7002(b) does not give CMS the authority to delay the October 1 effective date. Only Congress may delay the effective date through new legislation. Therefore, the States are responsible for the full implementation and enforcement of the new law as of October 1.
Sometimes, a person becomes eligible for Medicaid benefits after he has submitted a written prescription to a pharmacy and has had the pharmacy fill the prescription. In these retroactive eligibility situations, the recipient often will return to the pharmacy and present evidence of his eligibility in order to get reimbursed by the pharmacy for whatever money the recipient previously paid the pharmacy to fill the prescription. Many have asked whether, in order to submit a claim to Medicaid, the pharmacy must obtain a compliant prescription.
Q: When it is determined that a Medicaid recipient is retroactively eligible for Medicaid and the recipient's original, written prescription was filled during a period when the recipient is now deemed to have been Medicaid eligible, must the pharmacy, prior to submitting a claim to Medicaid, obtain a tamper-resistant written prescription, a verbal order, a faxed prescription, or an e-prescription prior to submitting a claim to Medicaid?
A: When a Medicaid recipient is retroactively eligible for Medicaid after a pharmacy has already filled the recipient's prescription, CMS will presume that the prescription was compliant with section 7002(b), unless there is evidence that the prescription was non-compliant. This presumption applies to the filling of the prescription that occurred before the recipient became retroactively eligible for Medicaid. This presumption does not extend to any refills that occurred after the date on which the recipient is determined to be eligible for Medicaid. Such refills require that the pharmacy obtain a new, tamper-resistant prescription in compliance with section 7002(b). Alternatively, the pharmacy may obtain verbal confirmation of the prescription from the prescriber or may obtain the prescription from the prescriber by facsimile or e-prescription.
Emergency Prescription Fills
Q: Page two of CMS' August 17, 2007 State Medicaid Director letter (the "SMD Letter") allows a pharmacy to fill prescriptions on an emergency basis and, within 72 hours after the fill date, obtain a written prescription that complies with section 7002(b) or obtain the prescription by verbal communication from the prescribing doctor, by facsimile, or by e-prescription. Will CMS define "emergency fill," as discussed int eh SMD Letter? Is the emergency fill provision limited to certain drugs or to instances when the individual has no supply left?
A: CMS will not further define the "emergency fill" provision of the SMD Letter. Each State should refer to its own statues, rules, and regulations to define the term.
Q: May the pharmacy provide the full prescription to the patient in the emergency fill situation, or must the pharmacy only provide a 72-hour supply?
A: The pharmacy may provide the full prescription to the patient in the emergency fill situation, so long as the pharmacy obtains a compliant prescription in writing, or by telephone, fax, or e-prescription, within 72 hours.
Q: Do States have the authority to implement a "hold harmless" provision for pharmacies that document their pharmacists' calls, faxes, or other efforts to obtain a compliant prescription but that do not receive a response from the prescriber within the 72-hour period?
A: No. Section 7002(b) does not contain a "hold harmless" provision.
Drug Orders in Certain Institutional Settings
As noted on page one of the SMD Letter, section 1927(k)3) of the Social Security Act describes certain institutional settings, including nursing facilities, where outpatient drugs are not subject to section 7002(b). CMS has received many questions about drugs prescribed in institutional settings referred to in section 1927(k)(3) that are ordered by way of drug orders written in patient charts or in other written formats, where these orders are not written on prescription pads
Q: Must a written order provided in an institutional setting described in section 1927(k)(3), and separately reimbursed by Medicaid, that is written into the medical record and conveyed by medical staff to a pharmacy be executed on a tamper-resistant prescription pad?
A: CMS has concluded that a written order prepared in an institutional setting where the doctor or medical assistant writes the order into the medical record and then the order is given by medical staff directly to the pharmacy is considered "tamper resistant," so long as the patient never has the opportunity to handle that written order.
Prescriptions for Controlled Substances
Q: Federal law and many State laws require that all prescriptions for Schedule II controlled substances be written. If a non-tamper-resistant controlled substance prescription that complies with Federal and State law is presented to a pharmacy, may the pharmacy obtain verbal confirmation from the prescriber in order to satisfy the tamper-resistant requirement of section 7002(b)?
A: Yes. As long as the Schedule II requirements are satisfied, section 7002(b) can be satisfied through any of the methods set forth in the SMD letter, that is, through a prescription that is transmitted verbally, sent by facsimile, or sent through an e-prescription, or is written on compliant, tamper-resistant prescription pad.
Q: Does CMS' reference to "controlled dangerous substances" include State schedules of controlled substances?
In many cases physicians provide prescription drugs directly to patients (e.g., via samples).
Q: If the prescriber provides a drug directly to a Medicaid recipient, is a tamper-resistant prescription required?
Communication between Physician/Prescriber and Pharmacy
As noted on page one of the SMD letter, section 7002(b) does not apply to non-written prescriptions, that is, it does not apply to e-prescriptions; prescriptions transmitted to the pharmacy by facsimile; and prescriptions communicated to the pharmacy by telephone.
Q: Does the physician/prescriber have to be the individual who transmits a non-written prescription to a pharmacy?
A: No. A nurse or administrative staff person who is authorized to act on the prescriber's behalf may phone the pharmacy the order, send the order by facsimile, or electronically transmit the order to the pharmacy.
Q: Will the action of a pharmacist calling back a physician/prescriber and making appropriate documentation on the original, non-compliant written prescription make the prescription compliant for purposes of a subsequent Medicaid audit?
A: Yes. Documentation by the pharmacy of verbal confirmation of a non-compliant written prescription satisfies the requirements of section 7002(b).
Prescription Transfers between Pharmacies
Q: When Pharmacy #1 transfers a tamper-resistant prescription to Pharmacy #2 to be filled, will a facsimile or telephone call from Pharmacy #1 to Pharmacy #2 satisfy section 7002(b), or must Pharmacy #2 obtain direct confirmation from the physician/prescriber?
A: Pharmacy #2 need only obtain a phone call or a facsimile from Pharmacy #1 in order to confirm the authenticity of the tamper-resistant prescription that was previously delivered to Pharmacy #1. There is no need for Pharmacy #2 to obtain direct confirmation of the original prescription from the physician/prescriber.
Page two of the SMD letter states that section 7002(b) "does not impose additional requirements on States regarding retention of hard copy prescriptions. States may follow current State and Federal laws and regulations for record retention." Several States only require a pharmacy to retain a scanned copy of the original prescription.
Q: If a pharmacy notes in writing on the original prescription that it is tamper resistant and then scans the prescription, will this comply with section 7002(b) for purposes of a later audit?
A: It depends upon the law of the individual State. Each State will determine what, if any, changes the State will require to its record retention policies in light of section 7002(b).
Characteristics of tamper-resistant prescription pads
Q: Will CMS provide examples of existing State practices that meet CMS requirements?
A: The tamper-resistant prescription pad characteristics set forth by the several States that currently have tamper-resistant prescription laws and/or regulations in effect are all acceptable examples of all three of the characteristics set forth on page two of the SMD Letter. These States are California, Florida, Indiana, Kentucky, Maine, New Jersey, New York, Texas, and Wyoming. (Idaho's regulations currently require one tamper-resistant feature; therefore, Idaho's law is compliant with the guidance given in the SMD Letter through September 30, 2008, but not thereafter.)
Q: What are the "industry-recognized features" that CMS recognizes for the prevention of copying, erasure, or counterfeiting?
A: The tamper-resistant prescription pad characteristics set forth by each of the States that currently have tamper-resistant prescription laws and/or regulations in effect are all acceptable examples of existing State practices that meet the requirements set forth by the SMD Letter.
Q: Does the requirement of the use of an ink pen satisfy the second characteristic set forth on page two of the SMD Letter (i.e., a feature that "prevent[s] the erasure or modification" of information on a prescription)?
A: No, it does not. Ink can be erased and modified, and in part for those reasons, the use of an ink pen is not an industry recognized standard
Q: How do the characteristics set forth on page two of the SMD Letter apply to computer-generated prescriptions that are printed on plain paper and are then signed by the prescriber? Is there an industry-recognized feature to address computer printer paper?
A: A computer-generated prescription that is given to the patient to take to the pharmacy must be printed on compliant, tamper-resistant paper. Such compliant paper is available in the marketplace.
Q: Will CMS publish a list of approved vendors that print prescription pads on compliant, tamper-resistant paper?
A: No. As long as the prescription pads meet the requirements of the guidance in the SMD Letter, providers are free to choose whatever vendor they wish.
Q: Is there any restriction on who may supply prescribers with compliant tamper-resistant prescription pads?
A: Each State may determine the vendors from which a prescriber may obtain tamper-resistant prescription pads.
Q: Who will be responsible for ensuring that there is compliance with the requirements of section 7002(b)?
A: Primary responsibility for auditing Medicaid providers rests with the States. However, there are some circumstances in which CMS, the Office of the Inspector General of the U.S. Department of Health & Human Services, or some other Federal agency may have occasion to audit a pharmacy provider. When that occurs, the Federal agency will have authority to determine compliance with section 7002(b).
Medicaid as Secondary Payor
Q: Will there be resources to help pharmacists identify Medicaid as the secondary payor to help limit the number or prescriptions that may need to be reprocessed if the prescription was non-compliant?
A: Pharmacist-providers should consult with their State Medicaid agency for assistance in this area.
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