From Pain Medicine News (10/06/05)

Debate Begins ...

Will New Law Frighten Pain Doctors or Liberate Them?
Act Allocates Funds to States but Does Not Provide Model Program For Prescription Monitoring

The National All Schedules Prescription Electronic Reporting Act of 2005 became law on August 11 of this year. As a result, states will be eligible for part of a $60 million fund to establish or improve prescription-monitoring programs. The final version of the long-discussed legislation, dubbed NASPER, did not allay concerns that the bill could lead to further control or intimidation of physicians who treat patients in pain.

Laxmaiah Manchikanti, MD, the primary force behind the bill through three congressional sessions, said that physicians will soon learn firsthand that better information will boost their comfort level with prescribing controlled substances. Dr. Manchikanti said that since his home state of Kentucky instituted a drug-monitoring program, he has saved the salary of one nurse, who spent the bulk of her time checking to see if patients were doctor shopping.

"We have been much more comfortable about giving controlled substances now than before," said Dr. Manchikanti, Chief Executive Officer of the American Society of Interventional Pain Physicians.

One drawback, though, is that the legislation provides scant direction for how individual states should design their newly hatched programs, said Scott Fishman, MD, President of the American Academy of Pain Medicine. The academy supported the legislation, but some concerns remain, he said.

"It’s simply a bill that offers funding for any state that chooses to pursue prescription monitoring," he said. "The bill does not describe the monitoring that needs to be involved. Therefore it leaves the door open for a state to choose a very good program or a very bad program."

The legislation, passed by voice vote this summer, establishes a federal program–based at the Department of Health and Human Services–that will provide the $60 million in grants. The money will be disbursed during the period from 2006 to 2010. Data must be shared between states, primarily among prescribing physicians. Apparently federal law enforcement agencies will have limited access to the information. At least 20 states already operate some type of drug-monitoring programs, according to the American Society of Interventional Pain Physicians.

The Painful Tug-of-War

Several physician groups supported the final law, including the American Academy of Pain Medicine and the American Society of Anesthesiologists. Representatives of these organizations noted that the groups had made efforts during the development of the legislation to prevent intimidation of physicians, or what has been called a chilling effect.

For example, it was important that the Drug Enforcement Agency (DEA) officials couldn’ t sift through the database looking for unusual prescription patterns, said Tim Deer, MD, Chair of the Committee on Pain Medicine for the American Society of Anesthesiologists.

"That might lead to some unfair investigations," Dr. Deer said. "It might have led to some folks not treating cancer patients and other patients in severe pain as appropriately as they should." At the same time, he added, "we wanted to make sure, if law enforcement needed to investigate a physician or a group of people, that they had the ability to do so."

As written, the law specifies that the state may only disclose information to law enforcement officials if it is related to furthering an individual investigation. The legislation also stipulates that federal officials must file several reports that evaluate the relative impact of NASPER, including whether the state programs have reduced inappropriate prescription use. In addition, federal officials must determine if implementation has negatively impacted patient access to pain therapy.

Still, the legislation did catch some criticism during its lengthy congressional journey, led primarily by privacy advocates and some patient advocacy groups. Last year (2004), Rep. Ron Paul (R-Texas) spoke out against the bill, saying he was concerned about the potential erosion of medical privacy.

Siobhan Reynolds, President of the Pain Relief Network, an advocacy group for patients and their families, flatly stated that "this type of information is highly abusable by law enforcement." Ms. Reynolds pointed to a late 1990s survey by the American Pain Society, which showed that only 51% of those with severe pain have it under control. "You have to assume that large numbers of people are doctor shopping in order to simply get enough medicine to live," Ms. Reynolds said.

Monitoring in Action

Dr. Fishman expressed approval of the Nevada state monitoring program, saying it’s a good example of the type of approach he hopes states will develop under the new law. One particular advantage, he said, is that physicians can access drug information in real time, while patients are still in their offices. That level of detail was lacking in the NASPER legislation, he said, because it was primarily a funding bill.

Since the Nevada program was launched in 1997, officials have tracked an increase in the total number of controlled substance prescriptions used statewide–a rate that keeps pace with the state’s population growth, said Keith Macdonald, Director of the Nevada State Board of Pharmacy, which administers the drug database. The average number of prescriptions written annually for those patients who were the largest consumers of controlled substances declined from 159 in 1997 to 46 in 2002, the most recent year for which data are available.

"There are still people abusing and there always will be," Mr. Macdonald said. "But they don’t get away with as much."

Early on, the pharmacy board provided faxed reports on physician request. In 2003, the board launched a secure Web site, which physicians can access before or during a patient visit, said Mr. Macdonald. He recalled two instances of breached confidentiality in eight years, one involving a pharmacist and another involving a doctor’s wife.

The debate over whether law enforcement is encroaching upon the legitimate treatment of severe pain will continue, regardless of NASPER’s passage. DEA officials routinely stress that their prosecutions only involve a fraction of practicing physicians. During a press conference earlier this year, DEA Administrator Karen Tandy stated that her agency was involved in the arrest of 42 doctors in 2004 out of a total of nearly 1 million registered U.S. physicians.

Physicians involved with pain management remain edgy, Dr. Fishman said. "This is a very tense time for anyone who is aggressively treating pain. I think many are going to view prescription- monitoring programs, even though they might be very helpful and well designed, they may view them with a paranoid eye because of all that has gone on in the last year or so with the DEA and other events in the courts."

But John Prunskis, MD, FIPP, Co-medical Director of the Illinois Pain Institute and a NASPER supporter, said that physicians will closely monitor the DEA and state agencies to make sure they "are not profiling physicians who are legitimately prescribing controlled substances for patients who need them."

In the end, Dr. Prunskis said, patients in severe pain also will benefit from NASPER. "Patients who have legitimate pain can feel confident that the perception that they are a doctor shopper is no longer there."

–Charlotte Huff

Based on interviews with Laxmaiah Manchikanti, MD, Scott Fishman, MD, Tim Deer, MD, Siobhan Reynolds, Keith Macdonald, and John Prunskis, MD.