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CDC opioid-prescribing guidelines impede patients who ‘should not have to fight for access’
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Leaders of ASH, ASCO and the National Comprehensive Cancer Network submitted a letter to the CDC recently seeking clarification of the agency’s clinical guidelines on opioid use for pain management.
The letter called upon the CDC to clarify the intended audience for its guidelines on prescribing opioids “to address unintended implementation and reimbursement consequences that have been occurring in practice.”
The executives stated that the patient populations their members serve — including patients with sickle cell disease, patients undergoing cancer treatment, cancer survivors and those receiving palliative care — had unique pain management needs that are not specifically addressed by the CDC’s guidelines, upon which some payers were basing reimbursement decisions.
“A clarifying communication from the CDC on which patient populations are excluded from the guideline would be extremely helpful to both payers and prescribers,” stated the letter, signed by Robert W. Carlson, MD, CEO of the NCCN, Clifford A. Hudis, MD, CEO of ASCO, and Martha Liggett, Esq., executive director of ASH.
In its reply, the CDC wrote that the guidelines were “developed to provide recommendations for primary care clinicians who prescribe opioids for chronic pain outside of active cancer therapy, palliative care and end-of-life care.”
It added that due to the unique circumstances facing the aforementioned patient populations, decisions about whether to prescribe opioids for pain management should be based on clinical practice guidelines that apply to the patient’s situation.
The impact of the CDC’s clarification on clinical practice may be minimal, according to those who spoke with HemOnc Today about the topic. The real issue lies in the reimbursement policies of payers, many of which are applying more generic treatment guidelines to patients with atypical needs.
Dissecting the problem
The ASH/ASCO/NCCN letter acknowledged that the CDC’s opioid guidelines were not intended for the patient populations their members serve. However, “many payers are still inaccurately applying the CDC guidelines to patients in active treatment for coverage determinations relating to opioids,” the letter states.
Because of the intensifying attention being paid to the opioid crisis in the United States, prescribing opioids for pain management has received increased scrutiny from payers, many of which have tightened reimbursement policies, regardless of a patient’s specific needs. Although the CDC did not intend for its recommendations to guide care for patients with cancer or sickle cell disease, “the resulting actions by payers are extremely likely to cause unnecessary pain and suffering,” the ASH/ASCO/NCCN letter states.
Members of the Community Oncology Alliance share the concerns regarding opioid access and reimbursement, according to Fred Schnell, MD, FACP, medical director of the alliance.
“I’m sure that the intent of the original guidelines was not to deny these patients access to coverage but, de facto, they did in some cases, and I believe it was very appropriate that this letter was sent to the CDC,” he told HemOnc Today. “These are groups of patients that should not have to fight for access to necessary drugs.”
The problem, according to Schnell, lies in the authorization procedures demanded by payers — especially preauthorizations that are required to cover opioid prescriptions.
“I have noticed increased denials, primarily from payers when prescribing more than a 1-week supply of opioids,” Jai N. Patel, PharmD, BCOP, chief of pharmacology research at Levine Cancer Institute at Atrium Health and a HemOnc Today Editorial Board Member, told HemOnc Today. This includes opioids for patients who are actively receiving cancer therapies, he added.
Julie Kanter, MD, director of the adult sickle cell clinic at University of Alabama at Birmingham and a HemOnc Today Next Gen Innovator, said prior authorization is a major issue in addressing the pain management needs of her patients.
“It’s a frequent part of our practice — not just the denials, but the constant and never-ending prior authorizations that are required,” Kanter told HemOnc Today.
One example she relayed involved a patient being treated for pain associated with both sickle cell disease and lupus.
“She was not in the hospital, not in the ER and very rarely in the acute-care setting,” yet the patient suddenly was denied coverage for prescribed opioids, Kanter recalled. “She hadn’t changed her dose; it was only the recommendations that had changed.”
The burdens that preauthorization place on prescribers and their patients are widespread. Sixty-five percent of physicians reported waiting at least 1 business day for prior authorization responses, with more than a quarter (26%) reporting delays of up to 3 days, according to a recent survey by the AMA. Further, the survey showed that, on average, physicians must complete 31 prior authorizations per week, which requires nearly 15 hours of staff time per week.
Twenty-four hours may seem like a quick turnaround to the average person, but it could feel like an eternity to a patient dealing with a high level of quick-onset pain.
Patients with sickle cell disease can experience “acute pain that is excruciating,” according to Ifeyinwa Osunkwo, MD, MPH, director of the sickle cell disease enterprise at Levine Cancer Institute at Atrium Health and a HemOnc Today Next Gen Innovator.
“I think payers are afraid of covering opioids and they are interpreting the CDC guidelines as ‘chronic opioids are bad for everybody,’” she told HemOnc Today.
In her experience, payers are arbitrarily applying the CDC’s recommendations as a trigger for prior authorizations.
“It’s regardless of the diagnosis. I don’t even think they are looking at why the patient has been prescribed [opioids],” she said.
Communication breakdown
So why are these prior authorizations required for opioids that are clinically appropriate for the patient’s diagnosis?
Many payers, including Medicare, have established certain parameters around opioid reimbursement that act as a safety net to prevent abuse. In Medicare’s case, these constraints are a part of the Patients and Communities Act of 2019, a piece of legislation aimed at addressing the opioid crisis that went into effect Jan. 1.
The act allowed CMS to establish a “soft edit” that triggers a pharmacist to consult with the prescriber when the total opioid dose is above 90 morphine mg equivalents (MME) per day. It also limits Medicare patients to a 7-day supply of opioids if it is the first prescription they have received for the medication within the last 60 days.
The 90-MME threshold is not a prescribing limit, according to CMS, which states that it is “the level above which prescribers should generally avoid,” and cites the CDC guidelines as the source of this threshold. However, Medicare Part D and commercial payers are using this suggestion to guide reimbursement requirements.
These suggested restrictions may cause physicians to refrain from prescribing doses above 90 MME per day, even when clinically appropriate. In addition, they may limit prescribers’ ability to effectively manage their patients’ pain in a timely and sustained manner.
“It appears there is some disconnect there,” Schnell said. “It’s sometimes hard to understand what the payer community is thinking of when they establish rules and polices around complex subjects like opioid use.”
Issues around access to care are not limited to opioid use, he added. “It’s a particularly problematic area — restricting access. People are already suffering from cancer, and restrictions have the potential to make it more difficult for patients with a true need to get the treatment they really need for proper care,” Schnell said.
“This clarification from CDC is critically important because, while the agency's guideline clearly states that it is not intended to apply to patients during active cancer and sickle cell disease treatment, many payers have been inappropriately using it to make opioid coverage determinations for those exact populations,” Hudis said in a press release.
The CDC’s clarification letter provides “clearer guidance compared with the original” guidelines, Patel said. Specifically, he pointed out that the CDC acknowledges unique patient populations will require different opioid management strategies.
“I think it is important that CDC emphasizes that clinical decision-making should be based on the relationship between the clinician and patient, and physicians should use their best clinical judgment to prescribe opioids,” Patel said. “I think providers all along clearly knew this, but after the original CDC guidance they were scared to continue prescribing opioids.”
Osunkwo said the CDC’s clarification letter is a good step but feared it comes too late to affect how payers apply its recommendations to reimbursement policies.
“We have to inform those at the insurance companies that they need to interpret the guidelines in the appropriate fashion,” she said. “You can’t just have a blanket rule that cuts people off. They need to work with the providers to understand why they have prescribed opioids in certain cases.”
Osunkwo also called on the CDC to raise greater awareness about the issue.
“I think the [CDC] needs to do more than just send out the letter to the three professional societies,” she said. “They need to make sure that, somehow, this letter gets out to the insurance companies and other provider groups. They need to have a campaign around what it considers to be the responsible prescribing of opioids.”
Clinical impact
Because there is very little guidance about opioid-based pain management for patients with sickle cell disease, Kanter said she consults other professional sources to guide clinical decisions, and that the CDC’s guidelines have no impact on the process she deploys.
“In the pain and sickle cell disease world, I look more at current peer-reviewed articles, the practice recommendations of colleagues, and then my own experience,” she told HemOnc Today. “In other areas, I might look at ASH’s guidelines or the NHLBI. But the CDC is not the first place I would go.”
Kanter’s preferred strategy is to trust her instincts and provide pain management therapy to patients when clinically appropriate.
“I think you have to have a trusting relationship. For most of what I do, I believe the patient-provider relationship is key,” she said.
Patel, who routinely uses screening tools to assess the risk for opioid misuse, advises that prescribers and pharmacists systematically monitor patients for signs of addiction or aberrant behavior, in addition to other best-practice precautions.
“Shared decision-making is an important process of medication management, regardless of the type of drug,” Patel said. “I think the original CDC guidance had a negative impact on providers’ confidence to prescribe opioids even if he or she knew it was clinically appropriate.”
The lack of opioid management guidelines specific to patients with sickle cell disease has led Osunkwo to follow recommendations from the Substance Abuse and Mental Health Services Administration, a branch of HHS.
“They have great tools to help guide opioid risk assessments, tools to guide education of patients on the side effects of chronic opioid use and various risk mitigation strategies — such as prescribing naloxone — on their websites that were available way before the CDC put out guidelines for opioid misuse,” she said.
The patient-physician relationship is an important factor in Osunkwo’s decision-making process as well.
“Trust affords the doctor the comfort to address concerns about opioid overuse with the patient, or that opioids may not be the best treatment option for their specific situation, and encourage them to explore other options,” she said. “I have nearly 100 patients with sickle cell disease who I have gradually transitioned from high-dose oxycontin and methadone to buprenorphine as needed. The successful cases were those who trusted that my clinical practice was to do no harm.”
Osunkwo said that her patients can still rely on her to manage their pain appropriately when they experience acute flareups associated with their disease, including opioids if indicated.
One of the positive outcomes of the increased scrutiny is that physicians are taking greater care when prescribing opioids, such as better documentation of when they evaluate a patient for pain and exploring alternative pain management strategies for patients who have chronic pain, Osunkwo said.
“Remember,” she added, “patients with sickle cell disease and cancer can have pain that is not due to their unique disease.”
With more than 3 decades of experience as an oncologist in Georgia, Schnell agreed that certain patient populations — such as those with cancer — have unique pain management needs, and professional society guidelines, including those from ASCO, ASH and NCCN, help address these needs in a more effective manner.
Nevertheless, he argued that physicians still need to establish trust with their patients as they watch for symptoms of opioid abuse.
Schnell recalled that not more than a decade ago, getting access to opioids was far easier, and many physicians were overprescribing them. In today’s environment, the opposite is true because stigma has developed around opioid use and those who prescribe them — even when they are clinically justified.
“We have come full circle and are heading toward settling into a balance on where this issue should be,” Schnell said. “We are seeing a rebound effect that is making access to these drugs difficult again.” – by Drew Amorosi
References:
Dowell D, et al. MMWR Recomm Rep. 2016;doi:10.15585/mmwr.rr6501e1.
CMS. “A prescriber’s guide to the new Medicare Part D opioid overutilization policies for 2019.” Available at: www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE18016.pdf. Accessed on April 22, 2019.
AMA. “2018 AMA prior authorization (PA) physician survey.” Available at: www.ama-assn.org/system/files/2019-02/prior-auth-2018.pdf. Accessed on April 22, 2019.
For more information:
Julie Kanter, MD, can be reached at The Kirklin Clinic of UAB Hospital, 2000 Sixth Ave. South, Floor 5, Birmingham, AL 35233; email: jkanter@uabmc.edu.
Ifeyinwa Osunkwo, MD, MPH, can be reached at Levine Cancer Institute at Atrium Health, 1021 Morehead Medical Drive, Suite 5300, Charlotte, NC 28204; email: ify.osunkwo@atriumhealth.org
Jai N. Patel, PharmD, BCOP, can be reached at the Department of Cancer Pharmacology,
Levine Cancer Institute at Atrium Health, 1021 Morehead Medical Drive, Suite 3100, Charlotte, NC 28204; email: jai.patel@atriumhealth.org.
Fred Schnell, MD, FACP, can be reached at Community Oncology Alliance, 1225 New York Ave. NW, Suite 600, Washington, DC 20005.
Disclosures: Kanter is a member of ASH and NHLBI sickle cell advisory boards and reports no relevant financial disclosures. Osunkwo, Patel and Schnell report no relevant financial disclosures.