Little Known Committee Setting New Rules for Opioids

By Pat Anson, Editor

You can add the NCQA to the alphabet soup of agencies and organizations trying to rein in opioid prescribing.

Like the CDC, FDA, DEA and CMS, the National Committee for Quality Assurance (NCQA) is targeting high doses of opioid pain medication, as well as patients who see multiple prescribers and use multiple pharmacies.

NCQA is a little known non-profit organization that plays a big role in determining the standard of care expected of healthcare providers. It manages accreditation programs for physicians, medical groups and health insurance plans by measuring and ranking their performance against a set of standards known as the Healthcare Effectiveness Data and Information Set (HEDIS).

In other words, NCQA decides who is doing a good job and who is not, based on guidelines that it sets for the healthcare industry. That makes it a very powerful and influential organization.

In a proposed new HEDIS standard for opioid prescribing, NCQA will set a daily ceiling on opioid medication at 120 milligrams morphine equivalent dose (MED) when prescribed for 90 consecutive days or longer. The number of prescribers would also be limited to no more than four, as would the number of pharmacies.

Any insurer or provider in violation of these standards would be red flagged, and if too many violations are found they risk losing their accreditation, a heavy price to pay for anyone in the healthcare industry.

In a statement explaining the proposal, NCQA said opioids may be prescribed for acute conditions such as post-surgical pain and for chronic pain conditions “such as sickle cell disease or late stage cancer.”

“The appropriate use of opioids can be vital to pain management, but there is limited evidence for the long-term beneficial effects of opioid use for chronic pain management for nonterminal conditions. In addition, long-term daily use of opioids can lead to increased tolerance (higher doses are needed to feel the effects). Taking excessive amounts of opioids can result in overdose, which may lead to death. Long term opioid use can lead to addiction or dependence; therefore, patients prescribed opioids should receive regular, rigorous monitoring and screening.”

Critics says the proposal makes no allowance for patients who are currently stable on high doses of opioids above 120 MED, who may be involuntarily tapered to a lower dose under the new HEDIS standard.

"HEDIS measures typically seek to advance improvements in care quality by incentivizing health care systems to focus on particular procedures or outcomes. Historically there have been occasional challenges with promotion of health quality measures that made sense at the system level, but turned out not to be very good when routinely applied to individual patients across the board,” said Stefan Kertesz, MD, a primary care physician and Associate Professor at the University of Alabama at Birmingham School of Medicine. 

“What seems desirable at the system level (overall lower opioid prescribing) may put patient-centered care at risk. Most importantly, the impact of this proposed quality metric might be to push providers to engage in involuntary opioid discontinuation on currently stable patients, a course of action that the CDC Guideline did not recommend."

The CDC guidelines released last year are voluntary recommendations intended only for primary care physicians. However, they are being implemented as mandatory rules for all prescribers by many insurance companies and in several states.

NCQA is seeking public comment on its opioid proposal, not only from physicians, but patients as well. To post a comment, click here (a detailed registration is required). Comments will be accepted until March 22.

CMS Public Comments End

Meanwhile, the Centers for Medicare and Medicaid Services (CMS) has ended its public comment period on new rules for opioids under Medicare’s Part D prescription drug plans. CMS wants to adopt the CDC’s guidelines as official Medicare policy, but make them mandatory for all prescribers and patients. Punitive action could be taken against providers and patients who don’t follow them.

A CMS ceiling on opioid doses would be set as low as 90 MED. Patients who receive opioids from more than 3 prescribers or more than 3 pharmacies during a 6 month period could potentially be dropped from Medicare coverage. Doctors and pharmacists could also be dropped from the Medicare network.

“These changes pose serious risks to some patients who currently receive opioids,” said Kertesz in a letter to CMS signed by 82 other physicians, including some who helped draft the CDC guidelines.

The letter warns that pain patients are already being involuntarily tapered by doctors off high opioid doses, causing some to stop working and become bedridden.

“While some small studies do report favorable outcomes from voluntary opioid tapers carried out by experts, there exist no data to justify involuntary dose tapering carried out by clinicians lacking expertise. And worse, there are a rising number of reports of patient harms, including suicide and death,” the letter states. “CMS mandates will cause previously stable patients to suffer acute withdrawal with or without medical complications, including death.”

To see a full copy of the letter, click here.

As PNN has reported, the insurance industry appears to have played a major role in drafting the CMS plan, which closely follows a 62-page “white paper” prepared by the Healthcare Fraud Prevention Partnership, a coalition of private insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud. 

The white paper goes far beyond fraud prevention, however, by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed.  The white paper was drafted largely by insurance companies, including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation.

CMS only accepted public comment on its opioid proposals that were emailed, instead of using the Federal Register, where all comments become official public record and are easily available for public inspection. The agency routinely uses the Federal Register for other rule and policy changes.

Asked by PNN why the Federal Register was not used this time, a CMS spokesman said the agency would have no comment. The agency plans to publish its final rules on April 3. Posting the rules in the Federal Register and asking for public comment would have delayed their implementation.