Medicare to More Closely Scrutinize Opioid Prescribing

Alicia Ault

December 08, 2017

Medicare will more closely scrutinize opioid prescribing and dispensing beginning in 2019, following through on a proposal outlined in a major 2016 law aimed at addressing the opioid crisis.

The Comprehensive Addiction and Recovery Act of 2016 (CARA) directed the federal health program to identify Medicare beneficiaries at risk for substance misuse and require those found to be inappropriately using opioids to receive prescriptions from a single clinician and a single pharmacy.

This type of "lock-in" program has been used by state Medicaid programs since the 1970s. Its inclusion in CARA was supported by consumer advocates, pharmacy organizations, and physician groups, such as the American Medical Association (AMA), but with caveats.

The Centers for Medicare & Medicaid Services (CMS) has now proposed the rules to implement the lock-in. At press time, the AMA and pharmacy groups said they were still studying the regulations and referred Medscape Medical News to comments made after the passage of CARA. CMS is accepting comments on the new regulations through January 16, 2018.

The agency believes that the program could not only help prevent opioid dependency in beneficiaries but would save Medicare some $13 million in 2019, owing to fewer prescriptions. The cost will be $2.8 million per year, which will primarily be borne by Part D drug plans.

Essentially, the rules build on Part D prescription drug plans' existing drug utilization review (DUR) programs. In 2013, CMS instituted an opioid overuse policy that required Part D plans to monitor opioid prescribing to help flag inappropriate use.

As a result, from 2011 (before the new policy) to 2016, high-risk opioid use declined by 61% (representing more than 17,800 beneficiaries), even as Part D enrollment increased 38% ― from 31.5 million to 43.6 million beneficiaries during the same period, said CMS in the proposed rules.

The CARA lock-in program, which would require additional steps by Part D plans, would be voluntary.

Cynthia Reilly, project director of the substance use prevention and treatment initiative at the Pew Charitable Trusts, told Medscape Medical News that she believes Part D drug plans will be interested in participating in the new Medicare lock-in program, because many of them now take part in opioid-targeted utilization review.

"This legislation will help save lives," said Mark Merritt, president and CEO of the Pharmaceutical Care Management Association in a statement after the passage of CARA.

"The key to curbing 'drugstore shopping' for controlled substances is to stop improper prescriptions from being filled at the pharmacy counter in the first place," said Merritt, whose organization represents pharmacy benefit management plans that administer drug benefits for Medicare Part D plans, employers, and others.

The Medicare Rights Center, a national, nonprofit consumer service organization that works to ensure access to affordable healthcare for older adults and people with disabilities, also praised the lock-in provision soon after CARA was enacted.

At-Risk Criteria

Just how many beneficiaries may be at risk for opioid misuse is unclear. The Government Accountability Office (GAO) said in an October 2017 report that Part D plans are not doing a good job of identifying those beneficiaries through DUR programs.

The GAO said that CMS was failing to help at-risk beneficiaries in a number of ways. "CMS does not identify providers who may be inappropriately prescribing large amounts of opioids separately from other drugs, and does not require plan sponsors to report actions they take when they identify such providers," said the GAO. "As a result, CMS is lacking information that it could use to assess how opioid prescribing patterns are changing over time, and whether its efforts to reduce harm are effective."

CMS's current guidance for Part D plans says beneficiaries should be identified as being at high risk if they received a total daily morphine milligram equivalents (MME) of greater than 120 mg for 90 consecutive days; have received opioid prescriptions from four or more providers in the previous 12 months; and have received opioids from four or more pharmacies in the previous 12 months.

Patients with a cancer diagnosis or in hospice care were excluded from monitoring.

According to the GAO, some 33,000 beneficiaries would have been flagged as being at risk under the guidelines, which have been in place in since 2013, but more than 727,000 had use of more than 90 MME. Under DUR, 18% of beneficiaries flagged had appropriate opioid use, said the GAO. Almost 40% of cases were resolved without restricting opioid prescriptions. A little more than 1% of flagged beneficiaries were denied opioids.

In 2018, beneficiaries will be flagged using the March 2016 Centers for Disease Control and Prevention guideline on prescribing opioids for chronic pain, which recommends 90 MME daily as a threshold of concern.

Under the new rule, CMS is proposing that in 2019, beneficiaries be flagged as being at risk if they have use of opioids with an average daily MME greater than or equal to 90 mg for any duration during the most recent 6 months and if they have either four or more opioid prescribers and utilize four or more opioid dispensing pharmacies, or six or more opioid prescribers, regardless of the number of opioid-dispensing pharmacies they utilize.

Patients with cancer, in hospice, or in long-term care facilities would be excluded. The AMA had urged that patients receiving medication-assisted treatment for a substance use disorder also be excluded, but CMS said it would not do so.

"It is these beneficiaries who are among the most likely to benefit from a drug management program," the agency notes in its proposed rules.

Some organizations have suggested that CMS's list of frequently abused drugs, which is used to identify beneficiaries at risk, include other or all controlled substances, such as benzodiazepines, sedatives, and certain muscle relaxants.

"We are not persuaded," said the agency. "Opioids are unique in that there is generally no maximum dose for them in the FDA [US Food and Drug Administration] labeling."

Reilly said that not considering other drugs of abuse, especially benzodiazepines, is a shortcoming. "We know that's where a lot of the risk is in terms of overdose," she said.

CMS said that although opioids will be the focus of the 2019 effort, that could change in succeeding years.

Doctor-Patient Relationship Jeopardized?

Once beneficiaries are identified as being at risk, Part D plans will be required to contact the prescriber to determine whether the opioid use is appropriate.

Also, Part D plans must notify beneficiaries in writing that they have been flagged as engaging in potentially risky opioid use.

The AMA expressed some concern that a note from the plan might create confusion and harm the patient-physician relationship.

"Notices sent by a Part D sponsor to patients or patients' caregivers who have not discussed the drug risks with their physicians will interfere with patient-physician relationships, harm trust, and potentially lead patients to abruptly discontinue therapy," said AMA Executive Vice President James Madara, MD, in a letter to CMS in November 2016.

"Patients with substance use disorders need to be referred for treatment. There needs to be hands-on coordination of patient care, which a letter from a Part D plan simply cannot accomplish," he said.

After reviewing the case with the prescriber, the Part D plan can move to limit that beneficiary's access to opioids by locking them in to a single prescriber and a single pharmacy, but not without the agreement of the prescriber. The plan also has to notify the beneficiary that he or she is being put into the program.

Beneficiaries can appeal their at-risk designation and their placement into a lock-in program.

Reilly said the regulation does a good job of establishing strong beneficiary protections. It provides exceptions to the one-pharmacy rule ― for instance, in situations in which geography or weather is a factor.

But, she said, some beneficiaries who could be steered clear of opioid dependency still might fall through the cracks. Some individuals with substance use disorders not only visit multiple pharmacies but also visit emergency departments, which will not be tracked by the Part D plans.

Another red flag for a patient's being at risk is that patient's receiving multiple prescriptions for controlled substances that are in the same therapeutic class. Those prescriptions will not be flagged under the new program.

"By looking at either more criteria or more clinically complex criteria, we can do a better job of identifying those patients who are at greatest risk," said Reilly.

The regulations also do not direct the plans to refer patients who may have substance use disorders to treatment. That's "something we should strive for," she said.

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