Physicians face Medicaid's April 1 deadline for tamper-proof Rx pads

Doctors must use pads with at least one security feature by next month and three features by Oct. 1.

By Doug Trapp, AMNews staff. March 24/31, 2008.

Washington -- Most physicians are prepared to meet the April 1 federal deadline for writing many Medicaid prescriptions on tamper-resistant pads, according to medical, pharmacist and other organizations. But these groups continue to reach out to doctors who may be unaware of, or confused about, the law.

By April, written Medicaid prescriptions must have at least one feature to prevent unauthorized copying, erasure or modification, or counterfeiting. Written prescriptions must have a feature from all three categories by Oct. 1. The law, adopted by Congress as part of a military spending act in May 2007, does not apply to electronic, faxed or phoned prescriptions, or those paid for by Medicaid managed care organizations, according to the Centers for Medicare & Medicaid Services.

Physicians looking for information about the law, such as where to purchase prescription pads, are encouraged to contact their state Medicaid agencies or their medical societies. They also can visit a National Assn. of State Medicaid Directors Web page dedicated to the issue (www.nasmd.org/issues/trpp.asp).

Stakeholder organizations, including the American Medical Association, have worked closely with CMS in the last few months to clarify the law's requirements, including which security features will meet the standards. These discussions culminated in a Jan. 16 meeting of groups representing physicians, pharmacists, chain pharmacies, state Medicaid directors and others. This gathering led to a broad list of recommended features in the three security categories. CMS endorsed the list on Feb. 1.

The agency left states with the authority to determine which specific security features physicians should use. CMS "didn't want to be perceived as giving the final directive to the states as to what it was they had to do," said Phillip Scott, senior vice president for sales and marketing for the National Council for Prescription Drug Programs, a standards organization for the pharmacy industry. The council convened the Jan. 16 meeting.

As of press time in mid-March, about 15 states had not issued guidance beyond the CMS-endorsed standards, said Hrant Jamgochian, director of congressional and state relations for the American Pharmacists Assn. However, states continue to issue new guidance daily, he said.

The American College of Physicians is encouraging doctors to begin using prescription pads with three security features immediately to meet the Oct. 1 requirements and save time later, said Neil Kirschner, PhD, ACP senior associate for regulatory and insurer affairs. Prescription pad orders can be delivered in about two weeks on average, he said.

The law was originally to take effect on Oct. 1, 2007, but in late September 2007 Congress delayed implementation by six months because of concerns there wasn't enough time for affected parties to understand the law's requirements, much less meet them. The AMA and other organizations pushed for the postponement.

The situation would have been much worse without the extra time, Jamgochian said. "The six-month delay was absolutely critical."

Sources said that most physicians should be aware of the April 1 deadline and the requirements of the law, but that there will be exceptions. "We're going to run into circumstances in which physicians do not know that this has occurred," Scott said. But he added that he doesn't "think that the sky is falling."

The ACP's Dr. Kirschner said most doctors have the information they need. The American Pharmacists Assn. will be monitoring the situation closely, Jamgochian said.

The American Medical Association will solicit feedback from physicians on their use of tamper-resistant pads and any problems they encounter in complying with the law.

EMRs pose a challenge

Physician practices that print prescriptions on plain blank paper through electronic medical records systems have had the most difficulty meeting the April 1 deadline, Dr. Kirschner said. CMS is letting these practices use blank paper until Oct. 1, when they must begin using paper with a security feature designed to prevent unauthorized copying, such as watermarks or paper on which the word "void" appears when copied.

States will be the first line of enforcement for the Medicaid Rx rule. They have the authority to design programs to verify that prescription security rules are being followed. CMS or other federal agencies might check compliance through audits of pharmacists, according to CMS spokeswoman Mary Kahn. Those found to be out of compliance ultimately could lose Medicaid reimbursement for those prescriptions, among other penalties.

Pharmacists who receive noncompliant Medicaid prescriptions on April 1 may still be able to fill those prescriptions by calling physicians to confirm authenticity. If there are no other applicable restrictions or laws, CMS guidance allows pharmacists to fill noncompliant prescriptions if the physician provides a verbal, faxed, electronic or compliant written prescription within 72 hours after the prescription was filled.

The agency could not estimate what percentage of Medicaid prescriptions will be affected by the law, according to Kahn. About 330 million Medicaid prescriptions not paid for by managed care plans were written in 2006, according to the National Assn. of Chain Drug Stores.

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 ADDITIONAL INFORMATION: 

Recommended Rx pad features

A cross section of interest groups has developed a list of prescription pad features to satisfy a Medicaid Rx security law taking effect April 1. Precautions are divided into three categories. Written Medicaid prescriptions must have at least one feature from one category by April 1. Pads must include one security element from all three categories by Oct. 1. Some options are highlighted in the sample prescription.

Category one: Features to prevent unauthorized copying

1. Pantograph: The word "void" appears when the prescription is photocopied.
2. Security back print: Words, such as "security prescription," printed on the prescription's back.
3. Reverse "Rx" or white area: "Rx" symbol or white area that disappears when photocopied at a light setting.
4. Watermarking: Paper with watermarks.

Category two: Features to prevent erasure or modification of information

1. Non-white background: Paper's background features a solid color or consistent pattern.
2. Quantity ranges: Boxes that can be checked by the physician to indicate the number of doses.
3. Refill indicator: Indicates the number of refills allowed.
4. Rx limit: A line specifying the number of prescriptions allowed for different drugs on the same form.
5. Quantity and refill borders: For EMRs, quantity or refill limits appear between asterisks; quantity or refill limits also could be spelled out.
6. Chemically reactive paper: Exposure to solvents, oxidants, acids or alkalis will leave a visible mark.
7. Paper toner fuser: Special toner bonds tightly to paper, making modification difficult.

Category three: Features to prevent counterfeiting

1. Features list: A complete list of security features on the paper (highly recommended).
2. Serial number: Unique number for each prescription, which may or may not be sequential, but should be reported to the state to be valid.
3. Batch number: For states with approved vendors, a number identifying each batch of prescriptions.
4. Encoding techniques: Bar codes used to encode a serial number, for example.
5. Logos: Sometimes used as part of the background color or as a pantograph.
6. Metal strip: A strip of metal embedded in the paper.

Source: National Council for Prescription Drug Programs, February

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