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Medicaid Rx pad security rule is delayed

The AMA applauds postponement of the compliance deadline, as stakeholders plan to seek further clarification from CMS.

By Doug Trapp, amednews staff. Oct. 15, 2007.

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Washington -- Physicians and pharmacists now have six more months to prepare for a law requiring many Medicaid prescriptions to be written on tamper-resistant pads.

Congress adopted the delay in late September. President Bush signed the measure Sept. 29 -- two days before the new law was to take effect.

The provision mandating such pads was part of a military spending bill adopted in May. It required that by Oct. 1, written Medicaid prescriptions have at least one feature to prevent unauthorized copying, erasure or modification, or counterfeiting, and include all three features by Oct. 1, 2008.

The Centers for Medicare & Medicaid Services issued guidance on Aug. 17 specifying that the law did not apply to prescriptions paid for by Medicaid managed care organizations or to electronic, faxed or phoned prescriptions, among other exemptions.

Stakeholders on the issue, including the American Medical Association, generally applauded the vote to postpone the rules until April 1, 2008. "The six-month delay addresses physicians' concerns that the implementation deadline of Oct. 1 was unreasonable and could harm Medicaid patients' access to prescribed drugs," said AMA Board of Trustees Chair Edward L. Langston, MD.

John Norton, spokesman for the National Community Pharmacists Assn., said a longer delay would have been a lot to ask for. "Six months is what we figured was ultimately reasonable."

American Pharmacists Assn. spokesman Hrant Jamgochian gave a qualified thanks for the delay. "At the same time, it doesn't compare to the 18 months it took to implement the New York State program," he said.

Congressional lawmakers had introduced other legislation to postpone the law for a longer period or scale it back. The House version of the Patient and Pharmacy Protection Act of 2007 permanently would have limited the measure to Schedule II controlled substances. The Senate version would have initially limited the law to Schedule II drugs, then applied it to all prescriptions on Oct. 1, 2009.

But both bill sponsors opted instead to support the six-month delay. Sen. Sherrod Brown (D, Ohio), sponsor of the Senate pharmacy bill, said postponing implementation would prevent chaos in pharmacies and allow Medicaid beneficiaries to fill prescriptions without interruption. Rep. Charlie Wilson (D, Ohio) called the move "just good common sense."

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. That's out of a national total of 3.42 billion prescriptions overall.

It wasn't yet clear how many of those prescriptions the CMS guidance would exempt from the law.

Nine states have programs using prescription pads with security features meeting all CMS requirements, according to CMS.

More to clarify

CMS issued a six-page "frequently-asked-questions" document on Sept. 13, in addition to its three-page Aug. 17 guidance on the law. But Jamgochian said the agency still had questions to answer.

For example, he asked, what happens if a pharmacist accepts a prescription that doesn't meet the security feature requirements? "Does that mean the pharmacist is going to be on the hook for that?"

Also, can pharmaceutical companies or pharmacies provide these new pads to physicians for free? "That might potentially help with streamlining and standardizing," Jamgochian said.

CMS' Aug. 17 guidance said pharmacists could provide emergency refills if they receive a compliant prescription within 72 hours. But does this rule preempt the laws of such states as Virginia, which allows pharmacists to wait one week for the proper prescription?

Whether the newly passed provision delayed the entire national law by six months or only the law's first phase was not clear at press time. The Aug. 17 CMS guidance said prescription pads were to have had at least one security feature by Oct. 1, 2007, and all three features by Oct. 1, 2008. The agency did not respond to calls regarding this issue.

"That's one of the questions we're going to follow up with CMS with," Jamgochian said.

The extra six months should provide enough time for family physicians to prepare to comply with the Medicaid prescription pad law, said John Swanson, director of the American Academy of Family Physicians' practice support division.

Some physicians have experienced difficulty acquiring prescription pads to meet the law, said Cynthia Hughes, a coding and compliance specialist with the AAFP.

Swanson, however, said the AAFP had not been deluged with phone calls from members about this issue. "I would be surprised if there were a lot of people who were not aware," he said.

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