State Medicaid program limits access to a drug treatment, upsetting advocates

July 16--As heroin and other opioid-related overdose deaths continue to rise across Maryland, some who treat addiction are criticizing a move by the state to limit access to a drug treatment used by thousands of patients and considered effective.

The state Department of Health and Mental Hygiene changed this month the list of drugs preferred by Medicaid to exclude Suboxone Film, a small, medication-infused sheet that dissolves under the tongue and is used to taper addiction by interrupting the effects of opioids in the brain.

The health insurance program for the poor replaced the film with a pill called Zubsolv.

In a letter published in The Baltimore Sun last month, Van T. Mitchell, secretary of the state Department of Health and Mental Hygiene, said the move was largely to counter the smuggling of the film into Maryland correctional facilities.

"Smuggling has been extremely problematic," he wrote in the letter, co-signed by Steve T. Moyer, secretary of the Department of Public Safety and Correctional Services. "Not only does it jeopardize prisoners' health and safety but it also jeopardizes the security of correctional staff."

Mitchell said the film has been "the most prevalent controlled dangerous substance" found in Maryland correctional facilities since 2014. Corrections officials seized 2,160 smuggled strips from January through May, up nearly 65 percent from the same period in 2015.

He also argued that the main ingredient in the film and pill, buprenorphine, remains available. The health department reports prescriptions of buprenorphine in all forms are rising -- to 11,132 in 2015 from 5,631 in 2010.

Shannon M. McMahon, deputy health secretary in charge of Medicaid, said Mitchell approved the switch after a recommendation from the department's pharmacy committee, which held a public hearing at which concerns about smuggling were raised. A sign-in sheet shows that most hearing attendees represented drug companies, but McMahon said efforts were made to communicate the change to treatment providers and pharmacies.

Some addiction specialists say that most Medicaid patients were prescribed the film when it became available three years ago and that switching might be tough.

The change "may destabilize their recovery," Dr. Leana Wen, Baltimore's health commissioner, wrote in a letter to Mitchell obtained by The Sun under public records laws. "Changes in medication formulation can and will lead to relapses, overdoses and deaths."

State data show there were 1,259 fatal overdoses in Maryland in 2015, up 21 percent from the year before and double the number in 2010. Officials have largely blamed the spike on heroin and the powerful synthetic opioid fentanyl that is sometimes mixed with heroin.

Corrections officials said they do not prescribe buprenorphine; rather, they provide another drug, methadone, for those coming into Baltimore facilities with opioid addictions.

Marian Currens, president of the Maryland Association for the Treatment of Opioid Dependence, representing about 80 treatment programs, has raised objections to the switch. She is a nurse practitioner with the Center for Addiction Medicine in Baltimore and says her Medicaid patients now have to receive Zubsolv while those with private insurance have more choices.

"Now it's insurance-driven, not patient-driven," she said.

Treatment providers fear that more recovering addicts could be derailed by the switch, which some said caught them off guard.

Dr. Christopher Welsh, an addictions psychiatrist, said the switch also caught some pharmacies by surprise and they did not stock enough Zubsolv, which comes in several dosage levels.

The confusion, coming on the Friday before the Fourth of July weekend, caused disruption for patients wrestling with recovery, said Welsh, medical director of the University of Maryland Medical Center's substance abuse service.

"It angers a lot of us in the field who already struggle to provide the kind of care that we can to these patients," Welsh said.

Dr. Yngvild Olsen, medical director for the Institutes for Behavior Resources/REACH Health Services in Baltimore, said that although the film and Zubsolv contain the same active ingredients, the "bioavailability" -- the amount that enters the body -- might differ and require the adjustment of dosages that were effective for patients.

"Change can be hard," Olsen said. "Once they're stabilized, the thought of ending up in withdrawal is frightening."

Under the switch, doctors will need to seek advance approval from Medicaid to use the film instead of Zubsolv.

The move to the pill also is raising concerns because Mitchell's former employer, the lobbying firm Manis Canning & Associates, represents Orexo US Inc., Zubsolv's maker.

Public records show that Mitchell's registration as a lobbyist ended before Orexo became the firm's client. And the health department's McMahon said Mitchell approves a variety of changes in the pharmacy program and always has relied on the recommendation of the pharmacy committee and staff.

McMahon could not explain why the specific Orexo brand was chosen for use by Medicaid when there are generic formulations available. The department cannot yet say whether there would be a cost savings.

The decision shows the validity of concerns expressed by some when Mitchell was appointed, said Craig Holman of the consumer watchdog group Public Citizen.

"This is very much a conflict of interest," said Holman, government affairs lobbyist for the Washington-based group. "This is exactly what we had feared. This vastly provides financial benefits for a former client."

Holman said Mitchell should recuse himself from any decision that affects clients of his former employer.

"It comes back to the public trust," said Jennifer Bevan-Dangel, executive director of the government accountability group Common Cause Maryland. "It puts the burden on him and on the lobbying firm to show that there's a firewall, and that [Orexo] is not able to take advantage of the connection."

Other state Medicaid programs have switched preferred medications, usually for economic reasons, said Dr. Stuart Gitlow, immediate past president of the American Society of Addiction Medicine's board of directors. He said companies offer deals, and under that system, the film has become widely used in recent years, as have generic buprenorphine tablets. The relatively new Zubsolv brand has a much smaller market share.

"Zubsolv and the film are biologically equivalent; they do the same thing and work in the same way," said Gitlow, also executive director of the Annenberg Physician Training Program in Addictive Disease at the University of Florida.

"Is this rocking the boat? No question," he said. "If I were a clinician and was told you must switch all your patients, I'd say, 'Hell, no.' That's a totally reasonable response. But if it's cheaper and bioequivalent, then as a society, we have to make that choice: Are we willing to place an undue hardship on a vulnerable population for reasons that aren't medical?"

Others in the treatment community said the answer should be no.

"They're making changes to an extremely important medication that can affect whether someone lives or dies," said Dr. Leonard Feldman, an associate professor of internal medicine and pediatrics at the Johns Hopkins University School of Medicine, who runs an urban health residency program at local clinics that largely prescribe the film for those in drug treatment.

He signed a letter to The Sun protesting the change, along with Deborah Agus, executive director of the Behavioral Health Leadership Institute, and Scott Nolen, director for Open Society Institute-Baltimore's drug addiction treatment program.

"It's perplexing and upsetting," Feldman said of the change.

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