By Pat Anson, PNN Editor

Doctors, patients and advocates are reacting with alarm to a proposal by the Centers for Medicare and Medicaid Services (CMS) that would require insurance companies to report “substantiated or suspicious activities” by healthcare providers, including “inappropriate prescribing of opioids.” Insurers would also be authorized to unilaterally suspend payments to pharmacies for “credible allegations of fraud.”

If adopted, critics say the sweeping rule changes would have a chilling effect on providers and put insurance company profits ahead of patient well-being.

At issue is a notice published in the Federal Register last month, which details changes proposed for Medicare and Medicaid programs for 2021 and 2022. The notice has drawn little attention from the public, news media or healthcare organizations, which have been preoccupied with the coronavirus pandemic.

Many of the rule changes proposed by CMS are being made to implement the SUPPORT Act, which was passed by Congress in 2018 to reduce opioid abuse and promote substance abuse treatment.

Current CMS policy allows insurers – known as “plan sponsors” -- to voluntarily report potential fraud by doctors and pharmacists. The proposed rule change would require such reporting, when there is “credible evidence of suspicious activities of providers or suppliers related to fraud, and other actions taken by the plans related to inappropriate opioid prescribing.”

Insurers would report allegations to CMS through an internet portal, while the public would be encouraged to call a fraud tip hotline. Credible cases of “bad actors” would then be referred to law enforcement, according to CMS:

"Implementing these provisions will allow CMS, MA (Medicare Advantage) organizations and Medicare Part D plan sponsors to share data and information regarding bad actors, take swift action based on such data and information, and achieve enhanced outcomes in our efforts to fight the opioid crisis. In addition, this regulation will provide the means for more effective referrals to law enforcement based on plan sponsor reporting, ultimately resulting in reduced beneficiary harm and greater savings for the Medicare program.” 

Insurers would be allowed to consider a wide range of factors to determine if opioid prescriptions are inappropriate, including a patient’s health condition, medical records, opioid dosage, refills, and even the “time and distance between a prescriber and the patient.”

Patient advocates say the plan gives too much power to insurers and wrongly assumes that prescription opioids play a major role in the opioid crisis.

“The regulations planned here will constitute a major regulatory burden on the practice of medicine and implicitly make the assumption that sponsors or pharmacists are better judges of patient benefit and risk than prescribers,” said Andrea Trescot, MD, Stephen Nadeau, MD, and patient advocate Red Lawhern, PhD, in a joint statement. 

“These rule changes assign major responsibilities and powers to Medicare Part D sponsors. Since these sponsors have a pecuniary interest in minimizing the drugs they pay for, profit rather than patient well-being will be the major driver of their procedures and protocols. Both physicians and advocates spend hours each week dealing with denial of care, including medications, by sponsors. The people denying the care are often not physicians and they make no attempt to access patient medical records to develop informed judgments.”

Under the CMS proposal, insurers would also be required to enroll patients deemed at risk for opioid abuse into “Drug Management Programs” that would limit which doctors and pharmacies they can see to obtain prescriptions for opioids and benzodiazepines, a class of anti-anxiety medication.  

‘Big Brother’ Approach

Although the CMS proposals have been publicly available on the Federal Register for over a month, only a few dozen comments have been received to date.

“This sounds like we (chronic pain patients) will be targeted for simply getting the care we need to sustain a basic level of living,” wrote one poster. “Often times, assumptions are made that we are drug seekers, drug abusers, and such. Sometimes it takes trying different medications and different doses to get to where we need to be in order to live life. This may look bad on paper to someone without clinical training, education, or experience. Things aren't always what they seem.” 

“My gosh you people are trying to fix a non-existent problem. The issue now is not prescription drugs that us senior citizens take. It is heroin and fentanyl analogs,” said another. “IT IS TIME WE AS A COUNTRY STOP TRYING TO FIX A MEDICAL ISSUE WITH LAW ENFORCEMENT. There is no need for the government to get between me and my doctor when it comes to my pain medication.”

Many posters are concerned that providers and patients could face sanctions over unproven allegations.

“I am EXTREMELY concerned for this ‘Big Brother’ approach you are taking yet again,” said another poster. “I do not have an addictive personality. What if someone decides to say I do? Then my doctor who is already living in fear of the DEA may go along with whatever determination this government decides to make about me.”   

“So the idea is to shut down doctors with a mere investigation? Based on accusation? Not even charged but only accused? This is truly a new low in individual rights,” said another. “I would think that doctors would almost entirely abandon controlled substances prescribing altogether. Perhaps the motivation for this.”  

While CMS says “a fraud hotline tip, without further evidence, is not considered a credible fraud allegation,” some worry that unsubstantiated claims could still result in sanctions against a provider.   

It was a complaint from a woman in upstate New York that recently led to a North Carolina doctor losing his DEA license. The woman doesn’t know Dr. Thomas Kline or any of his patients, but reported Kline to the state medical board because she didn’t like his tweets defending the use of opioid medication. Kline sees several patients from out-of-state, one of the red flags that CMS would consider suspicious.

“I think the sticky wicket is probably the words ‘credible allegations of fraud.’ Such as the Dr. Kline fiasco. THAT wasn't credible but the Board sure made it out to be,” says Rick Martin, a retired pharmacist and pain patient.   

What do you think of the CMS proposal? The public comment period ends April 6. To leave a comment, click here.