By Pat Anson, Editor

Here we go again.

That’s seems to be the reaction from many in the pain community to plans by the federal government to have pharmacists report suspicious activity by doctors who prescribe opioids to Medicare and Medicaid patients. (See “Medicare Takes Big Brother Approach to Opioid Abuse”)

The Centers for Medicare & Medicaid Services (CMS) says its new strategy to fight opioid abuse is aimed at “incentivizing prescribing behavior” by having pharmacists identify and report doctors who may be overprescribing opioids and patients who may be abusing them. 

“It is a terrible idea to pit pharmacist against physicians. It is an unbelievably perverse way to solve a serious healthcare problem that requires trust and collaboration among all the stakeholders,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine. “Many, many people with pain and addiction are going to be harmed by this decision.”

“This will only serve to further increase stigma and increase distrust between patients, their prescribers, and pharmacists,” says Anne Fuqua, a former nurse, chronic pain sufferer and patient advocate.

“Just the words ‘incentivized prescribing’ makes me shudder.  It may well help root out a limited number of substance abusers and decrease pharmacy claims for Medicare Part D and Medicaid, but this is neither an effective manner to intervene when substance abuse does exist nor an ethical way to decrease prescription drug benefit claims.”

CMS contracts with dozens of private insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in state-run Medicaid programs. Under the new policy, information about doctors and patients who’ve been red flagged by pharmacists would be shared through a database with all insurers. The companies would be empowered to “investigate provider and beneficiary behaviors that may be indicative of fraud or abuse.” Violators could be dropped from insurance networks or lose their coverage.    

“A policy like this, that encourages pharmacists to report the prescriber or patient to the insurer for investigation, is dubious enough.  It's even more serious that the allegations would be entered in a database whether or not they are proven,” said Fuqua. “This would be like your doctor saying they think it's possible a patient is misusing medication and then emailing this to all the doctors in your state.  Every element of this reeks of big brother and directly contradicts treating addiction as a health issue.”

“It appears that CMS is dictating that pharmacists perform activities that are both outside of their training and the legal authority granted to them under the state's practice act,” said Steve Ariens, a retired pharmacist and patient advocate. “Pharmacists don't have access to the patient's entire medical records. They are being told by CMS to both diagnose and prescribe what is right for a patient.”

“Many of the pharmacists I know are already overworked with other regulations to the point of PDMP’s not being updated in a timely manner. I know of patients who have been affected by this personally,” said Barby Ingle, president of the International Pain Foundation and a PNN columnist.   

“What a pharmacist believes about a medication’s appropriateness should not come into play when they are not trained on the medical aspects of chronic conditions. Pharmacists know about medication, but not in-depth information on diseases we are living with and therefore should not be making the call on what they deem suspicious on behalf of a prescriber.”

Medicare Policy Based on CDC Guidelines

CMS is basing many of its policy decisions on opioid prescribing guidelines released last year by the Centers for Disease Control and Prevention. The guidelines, which discourage doctors from prescribing opioids for chronic pain, are voluntary and meant only for primary care physicians. But they are being widely adopted by insurers and doctors throughout the country as a “standard of care,” even though the scientific evidence supporting many of the guidelines is weak.

CMS seems unconcerned by that lack of evidence.

“Where sufficient evidence was not available, the CDC guidelines are based on expert opinion, as noted by the CDC,” the agency said in a 30-page briefing paper on its Opioid Misuse Strategy.

“The guidelines were formed by consensus of mostly people with agendas, biased against opioids, and totally insensitive to the needs of people in pain. The dose limits suggested by the CDC guidelines are arbitrary, not evidence based,” said Dr. Webster. “

“Let's be clear about the CDC guidelines.  A major reason the guidelines were developed was to reduce cost of drugs for payers.  If Medicare and Medicaid patients have an increasing incidence of opioid use disorder it is because these people do not have any alternative treatments for their pain other than an opioid. 

“If CMS is going to endorse the guidelines that have little to no science basis, then they should mandate all of the alternative therapies to opioids have unlimited coverage and that payers be mandated to provide adequate coverage for the underlying reasons that lead to opioid use and mental health disorders.  This would more likely reduce the incidence of an opioid use disorder.”

CMS is not requiring insurers to cover alternative pain therapies, such as massage and acupuncture, but says it is a prioritizing efforts to develop more evidence to support their use.

Public Not Informed

CMS convened a “cross-agency working group” to develop its opioid misuse strategy, and says it is “working closely” with other federal agencies such as the CDC, Food and Drug Administration, National Institutes of Health, and the White House Office of National Drug Control Policy. Members of the working group were not identified.

“CMS sought representatives from every component of the agency to ensure a broad range of expertise and perspectives. This diverse group assessed the benefits, limitations, and improvement opportunities within CMS’s current policies and programs. The group then defined desired outcomes from the perspective of CMS’s unique role as a leading payer of health care and identified key actions to achieve those outcomes,” the agency said in a statement on its website.

But CMS never held a public hearing or sought public comment prior to the strategy’s release last week. Several medical organizations and patient advocacy groups contacted by Pain News Network were unaware the policies were even being developed. 

“I was not even aware that these new CMS policies were being created and as a patient on Medicare, I think that we should have been notified at minimum,” said Barby Ingle. “Our opinion as patients in the program should have been a part of the voice of something that will affect proper and timely access to care.”

“Society would never tolerate any other patient group being treated in this manner,” said Anne Fuqua. “It's no accident that this provision has been given so little attention.”

On its website, CMS says it now welcomes “input from clinicians, patients, consumers, caregivers, manufacturers, researchers and others.” But it never makes clear how interested parties can comment or participate, such as a notice or public comment period published in the Federal Register.

The secretive actions of the agency – so far – are similar to those used by the CDC in developing its opioid prescribing guidelines. For several months, the CDC refused to identify members of a “core expert group” that helped draft the guidelines, which were released in September 2015 to a small and mostly selected online audience.

Initially, the public was given only 48 hours to comment on the CDC guidelines -- a decision that was reversed after a public outcry and threats of a lawsuit. Over 4,300 public comments were later received online, most of them in opposition to the guidelines, which were released virtually unchanged in March 2016.

CMS has not responded to repeated requests for an interview about its opioid misuse policies. It is not clear when the policies will be initiated, who was involved in drafting them, or where the idea came from.

CMS caved into political pressure last year when it agreed to drop pain related questions from patient satisfaction surveys. Politicians, hospitals, the American Medical Association, and other health organizations all claimed the questions encouraged the overprescribing of opioids. CMS officials said there was no evidence that was true, but agreed to eliminate the questions in 2017 patient surveys. The agency is still working on a future set of questions to replace them.