Prescription-Pad Mandate Alarms Physician Groups

Physicians who treat Medicaid patients must use“ tamper-resistant” prescription pads beginning in October. The requirement, tucked in a massive budget bill, caught physician groups by surprise and sent them scrambling to alert their members.

The law (PL 110-28), enacted in May, will reimburse state Medicaid programs only for prescriptions written on so-called tamper-resistant pads as of October 1.

The law aims to make it harder for patients to obtain controlled drugs illegally and easier for the government to save money. The Congressional Budget Office estimated that the requirement will save taxpayers $355 million over the coming decade, mainly through preventing fraudulent prescriptions.

The fast-approaching start date leaves little time to educate doctors and pharmacists.

“Given the short time period remaining until this provision becomes effective in October, CMS [the Centers for Medicare and Medicaid Services] could greatly benefit the Medicaid program and its beneficiaries by quickly issuing educational information as to this payment prohibition,” said James H. Scully Jr., M.D., medical director of APA, in a July 13 letter to CMS that outlined a series of concerns with the new requirement, including the lack of a clear definition for “tamper-resistant” pads.

Although manufacturers of several prescription pads include different features aimed at thwarting their misuse, the law does not describe which features meet its criteria. “CMS does not have the legal authority to create a more constrictive meaning for 'tamper-resistant pad' than was created by federal statute,” wrote Scully.

APA and other physician groups, however, have urged CMS to provide information to prescribers, pharmacists, and CMS auditors regarding the features or types of tamper-resistant pads it would like to see.

A common feature of these pads is a chemical additive that reveals when efforts have been made to alter the paper, such as the appearance of the word“ void” when put in a copier.

Scully also requested that CMS help explain to pharmacists their legal duties in filling prescriptions presented by Medicaid patients, regardless of whether the prescriptions are written on the required pads. As long as a prescription is otherwise legally valid, pharmacists should fill it for the patient's benefit, he said.

“Patients should not suffer or be hindered in their ability to obtain their prescriptions because of payment issues outside their control,” Scully said.

The National Association of Chain Drug Stores (NACDS) and other pharmacy groups have echoed APA's concerns.

“We are very concerned about the act's tamper-proof prescription-paper provision on the ability of Medicaid beneficiaries to obtain their prescriptions,” said Steven Anderson, president and CEO of NACDS, in a July 19 letter to CMS and congressional leaders.

CMS plans to comply with Congress's statutory guideline for implementation, said Dennis Smith, director for Medicaid and State Operations at CMS, at a House Small Business Committee hearing last month. Because many states already have similar requirements, he said, implementation demands will be limited to the remaining states.

Scully told CMS that if the tamper-resistant pads end up costing significantly more than other types of pads, CMS should encourage state Medicaid programs to create financial offsets or credits to physicians for the purchase of the pads.

The new requirement will not affect physicians who have adopted electronic prescribing. The requirement, Scully said, could provide CMS with an opportunity to educate physicians about the advantages of electronic health records and how to transition to them.

Clinicians who are averse to adopting e-prescribing should order appropriate pads immediately, to avoid the possibility of a shortage, Scully said.

The impact of the new law remains unclear, but the National Association of State Medicaid Directors warned CMS that states have found that a growing number of health care providers have already expressed “dismay with the administrative burden imposed by new Medicaid regulations and audits, and in turn, some are choosing to terminate their participation in the Medicaid program.”

APA has contacted its district branches to brief them on the requirement and encourage them to contact their state pharmacy boards for details on ordering the tamper-resistant pads.

Reps. Marion Berry (D-Ark.) and Mike Ross (D-Ark.) have circulated a letter urging their colleagues to contact Medicaid officials and seek a delay in implementation of the requirement. They cosponsored legislation (HR 3090) introduced by Rep. Charlie Wilson (D-Ohio) on July 19 that would amend the prescription-pad requirement to apply only to class II narcotics, such as oxycodone.

“We have to find a reasonable approach to helping, not hindering, our health care providers deliver quality health care,” Ross said.

The text of PL 110-28 can be accessed at<www.gpoaccess.gov/plaws/index.html> by searching on the law number. APA's comment letter is posted at<www.psych.org/members/download.cfm?file=1718>.▪