The crackdown on opioid prescriptions is leaving chronic pain patients in limbo

http://www.vox.com/science-and-health/2017/4/7/14738292/crackdown-opioid-prescriptions-chronic-pain

Jenny Rellick was born with spinal muscular atrophy, a degenerative disease that causes muscles to waste away. Eight years ago, she was facing pain so severe that her doctors put her on a high-dosage regimen of two different kinds of opioids. One is a long-acting, time-released opioid called Kadian that delivers 100 milligrams of morphine or its equivalent (MME) throughout the day. The other is a short-acting dose of oxycodone, which she takes in 15 MME increments as needed. Today Rellick, 46, takes anywhere from 175 to 190 MME of these painkillers daily.

“Opioids give [her] the ability to think about something other than pain,’” said Ashley Carr, Rellick’s caregiver. (Rellick had a tracheotomy, which makes it difficult for her to speak, and Carr often helps translate for her.) “But that does not mean she is pain-free. Even on opioids, she is constantly in pain, but opioids reduce it enough that it’s not a constant thought.”

But Rellick, who lives in Alexandria, Virginia, may no longer be able to get the medication she’s become dependent on. Recently, her primary care physician decided she would only write one-time prescriptions for opioids for up to 30 days. Other pain specialists Rellick has seen have said they would cut her daily dose in half.

“If I have to cut down 50 percent, it won’t help my pain enough to warrant the side effects,” Rellick told me in an email.

Increasingly, chronic pain patients like Rellick who take high doses of opioids daily are confronting new restrictions on the strength of opioids or length of prescriptions that doctors can give. The aim of these new measures being implemented throughout the health care system is to curb the epidemic of opioid addiction and overdoses. (More than 22,000 overdose deaths in 2015 involved prescription opioids.)

But they’re creating a new conundrum: what to do about patients like Rellick who could be hurt by big cuts in their dosage.

“People have been on these high [opioid] doses for years, and [if] all of a sudden they’re reduced within a day, the potential unintended consequences are huge,” said Chinazo Cunningham, a professor of internal medicine at Albert Einstein College of Medicine who helped review the 2016 Centers for Disease Control and Prevention guidelines on opioid prescriptions.

A growing number of insurers and health care organizations are moving to regulate opioid prescription strength

Last spring, the CDC published a first-of-its-kind guideline on prescribing opioids for chronic pain that has reverberated throughout the health care system. The recommendations questioned the effectiveness of opioids in managing chronic pain and raised serious concerns about long-term use.

And individual insurers, state and federal agencies, and national health care accreditation organizations have either proposed or put into effect policies ranging from limiting the number of days an initial opioid prescription can last to restricting the strength of the actual doses doctors can prescribe.

In the state of Maine, for instance, the health department is requiring all long-term opioid users to reduce their daily doses to 100 MME by July 1. The National Committee for Quality Assurance (NCQA), a leading accreditation organization of health insurers and physicians, is moving to enact opioid dosage limits too.

What NCQA has proposed would be far-reaching — it would penalize health care providers who prescribe patients more than 120 MME daily over a three-month period.

The NCQA cautioned Vox that the specifics of how the measure would work are still being discussed, and a final version won’t be released until July. What’s more, if the measure is implemented, the first year will be a test period to collect data and determine whether it merits being included in the accreditation program.

“The idea behind the safety measure is identifying what the risky situations are that we think health plans can help clinicians manage,” said Mary Barton, an NCQA vice president. “If I’m a doctor, I might not know a patient is fulfilling prescriptions at multiple pharmacies, but the health plan has access to that kind of data.”

Government health care plans have also considered introducing rules to regulate opioid prescription strength. The Centers for Medicare and Medicaid Services considered implementing its own opioid dosage limits, which would have denied coverage to Medicare patients seeking prescriptions of 200 MME or higher and required extensive case reviews for opioid prescriptions of 90 MME or higher.

Ultimately, the CMS decided to not enact them in 2018, because “prescribing physicians … are in the best position to identify and employ best practices … for enrollees using high dosage opioids,” the agency said in a statement.

Stefan Kertesz, a primary care doctor and researcher at University of Alabama Birmingham who specializes in pain management, told Vox that some Medicare and commercial insurance plans have already started to deny payment for opioids over a certain dose threshold, even though it is not currently required.

“Insurers have already been permitted to be more aggressive, saying patients have to be brought down or else we’re going to stop payment,” said Kertesz. “But much of the regulation is actually initiated through insurers or states, who may have a different approach.”

There’s limited evidence that opioids are effective for treating chronic pain

An estimated 5 million to 8 million Americans use opioids to treat chronic pain. And according to a 2013 study, the vast majority who take the drugs daily get 40 MME or less. But 15 percent are in the same category as Jenny Rellick, taking more than 100 MME.

Because there is such a wide range in the dose levels among people using opioids long term, some doctors say limits like 120 MME (what NCQA has proposed) seem arbitrary.

“I strongly agree with the principle that we need to limit opioid prescribing,” said Joanna Starrels, a professor at Albert Einstein College of Medicine and part of the group that crafted the 2016 CDC guidelines on opioid prescriptions. “However, we need to apply this principle where it makes sense — to prevent people from getting to high doses in the first place, and to reduce doses for patients who are not benefiting. Targeting all patients with blunt instruments like dose limits is likely to compound the negative consequences of this epidemic.”

One of the most contentious issues is whether opioids should continue to be prescribed for chronic pain at all. There is limited data on their effectiveness, and the evidence we do have raises serious concerns about using them long term.

Most trials to measure opioid effectiveness have lasted six weeks or less. The CDC was unable to find a study that analyzed opioid use for longer than one year, but the few studies that were longer than six weeks were not promising. Some studies even found that long-term opioid use might increase sensitivity to pain.

Which is one reason doctors fear the impact of the hard dose limits, which don’t include plans to gradually taper patients on higher doses to lower doses.

Some patients are pushing back against “one-size-fits-all rules”

When Rellick and I last spoke, she wasn’t terribly optimistic about finding a doctor willing to treat her at her current medication levels. She has one month left of her prescription, and says she’s afraid of the pain and withdrawal she may face if her dose is decreased rapidly.

And Rellick isn’t the only long-term chronic pain sufferer frustrated with the new limits. In Maine, two business owners, who like Rellick have taken high doses of opioids (over 100 MME) for years to manage a degenerative disc disease, are seeking an exemption to the state health department’s requirement that all long-term opioid users reduce their daily opioid doses to 100 MME by July 1.

In an interview with the Portland Press Herald, the men’s attorney, Patrick Mellor, said the intentions of the state were good but the ruling was problematic because it was a “one-size-fits-all rule.”

“My clients, they are employers and business people who have never been in trouble and have been lawfully prescribed these medications for years to manage their pain. They don’t get high on these. They take them to function,” said Mellor.

Filed under: General Problems