Doctors Wait to See How CMS' Opioid Changes Play Out for Patients in Pain

Earlier this week, CMS tweaked an opioid policy aimed at Medicare Part D patients that had drawn criticism when it was first released in draft form. Critics said it would have sharply reduced access to opioids for those with chronic pain, people with cancer or other types of pain. Two palliative care doctors said they are waiting to see if the changes are implemented in a meaningful way for their patients.

In fact, most of the more than 600 comments CMS received about the proposal—to limit the average daily morphine milligram equivalent (MME) to 90 mg a day, and to limit the duration, drew outrage from patients with painful conditions who said they took their medicine responsibly and that opioids were necessary for them to get through the day with a minimum of pain.

One 49-year-old woman from Washington wrote that she is disabled because of ankylosing spondylitis, fibromyalgia, and Crohn disease. Her Part D insurer denied her monthly pain medications in February, and she wrote, “It took weeks to unravel the mess. My doctor spent hours on the phone, increasingly enraged at the insurer's untrained and inept staff, their lack of understanding of their own policies, and his frustration at simply trying to authorize the same medications he's deemed medically appropriate for me for years. My pharmacist similarly spent hours on the phone with them. As did I. It's madness.”

Chad D. Kollas, MD, is the medical director of palliative and supportive care at UF Health Cancer Center—Orlando Health. He's seen these issues firsthand with his patients. Now, he is taking a wait-and-see approach to see how the changes—targeting limits at those with acute pain–are really implemented.

Earlier this year, he was 1 of 180 who co-signed a letter to CMS during the open comment period on the proposal, voicing concerns about the proposed changes. Additional professionals signed on after the deadline, including 8 who had roles in the development of the CDC 2016 guidelines CMS and insurers have used to create safety policies around opioids in an attempt to cope with rising rates of substance use disorder.

In an interview and in a follow-up email with The American Journal of Managed Care^®, he described a variety of frustrations.

“CMS has given discretion to pharmacists for doses between 90 MME and 200 MME per day for patients who suffer from cancer pain, who are receiving palliative care and/or who are enrolled in hospice,” he said in an email.

However, he said the language that CMS is using is that they merely “recommend” opioid doses with that range; it does not mandate any exemption for any group of patients.

His concern? Patients receiving higher doses than 200 MME will still be subject to a “hard edit,” which would probably trigger a prior authorization discussion with someone at CMS, someone who is likely not to be a healthcare provider.

He said he is not ready to call this a victory for patients in pain.

“Pharmacists will be able to exercise their professional judgment when making their decisions, and the current climate suggests that many may pass the final decision along to CMS; our pharmacy at the cancer center is likely to be an exception (so this will help me a little bit),” he wrote. It will all depend on how it is implemented, and he is still anticipating "more trouble than before for cancer patients seeking to fill their opioid prescriptions."

A CMS official said it is their “expectation” that insurers would “implement a real-time opioid care coordination safety edit based on a cumulative dosage threshold the time of dispensing as a proactive step to engage both patients and prescribers about overdose risk and prevention.” The official language in the CMS announcement reads, "We also recommend that beneficiaries who are residents of a long-term care facility, in hospice care or receiving palliative or end-of-life care, or being treated for active cancer-related pain are excluded from these interventions."

Kollas’ other concern is that CMS has given “regulatory strength” to the 2016 CDC guidelines on opioids, which he said “were not meant to be equally applied to all patients with chronic pain” and are not based in science.

In his work with patients in his palliative care outpatient center, he surveyed 250 and found that 54% have experienced stigma at a pharmacy counter trying to fill a prescription, and 75% have had issues trying to get a prescription filled.

What happens next, he said, is that patients will have poor pain control while they wait for a prior authorization (PA) to go through. Kollas has 1.5 full-time equivalent nurses dedicated to dealing with PAs, which can take anywhere from 15 minutes on the phone to 6 hours.

In rural northern California, the majority of the patients that Michael Fratkin, MD, president and founder of a palliative care organization called ResolutionCare, cares for are on Medicaid. He has similar concerns and called for a “carve-out” of patients in palliative care.

Additionally, both Kollas and Fratkin expressed frustration with what happens when pharmacies do not have painkillers in stock, due to manufacturing limits on the number of opioids that can be produced.

The changing policies on opioids are leaving many patients in the lurch and suffering from withdrawal, “which are essentially sending them to the street to use,” said Fratkin.

And instead of using well thought-out interventions to address a substance use disorder problem, there is “reactivity and victim blaming,” he said.

“In the absence of thoughtful resources to support substance abuse treatment, pushing the problem underground may make the healthcare system feel a little bit better but it won’t move the bar on reducing the terrible impact of opiate addiction in our society,” said Fratkin.

Changing the supply side of opioids, creating a negative impact for patient care, doesn’t change the motivation of someone who has gone on to develop a substance use disorder, he said.

“This is not politics,” Fratkin said. "This is human suffering."