By Pat Anson, Editor

A new report to Congress by the Government Accountability Office (GAO) recommends that the federal government greatly expand the monitoring of Medicare patients who receive high doses of opioid pain medication, as well as the doctors who write their prescriptions.

If adopted, an estimated 727,000 Medicare beneficiaries who receive opioids in excess of 90mg morphine equivalent doses (MED) would have their prescriptions tracked by private insurers and reported to the Centers for Medicare & Medicaid Services (CMS). Critics say such a policy would have a chilling effect on doctors, who increasingly fear government sanctions for prescribing opioids.

In 2016, over 14 million elderly and disabled Medicare patients received an opioid prescription, and CMS spent over $4 billion paying for their opioid medication.

“A large number of Medicare Part D beneficiaries use prescription opioids, and reducing the inappropriate prescribing of these drugs is a key part of CMS’s strategy to decrease the risk of opioid use disorder, overdoses, and deaths,” the GAO report says.

“Despite working to identify and decrease egregious opioid use behavior — such as doctor shopping — among beneficiaries in Medicare Part D, CMS lacks the necessary information to effectively determine the full number of beneficiaries at risk of opioid harm.”

Under current CMS policy, patients are only considered “at risk” if they receive high dose opioid prescriptions from four or more providers and have them filled at four or more pharmacies. Last year, 11,594 Medicare beneficiaries met that criteria, a tiny fraction of those who receive opioids.

The GAO wants to change the criteria so that everyone prescribed a high dose would be monitored, regardless of how many doctors or pharmacies they use.  The principal author of the report said the recommendation is not aimed at taking patients off opioids or lowering their dose, but to improve the data on high dose prescribing.

“We are suggesting that CMS take a close look and monitor and track the numbers of people at risk of harm,” Elizabeth Curda, Director of GAO Health Care, told PNN. “We’re not suggesting CMS investigate 700,000 people who get more than 90mg per day. We want them to focus on how many people are getting these doses and what’s happening to that number. Is it going down? Is it going up?  We have this strategy to reduce harm, so we want to see it coming down.”

“Frankly this is unbelievable.  It is very hard for me to understand how reducing the amount of opioids to people in pain is going to help reduce the amount of smuggled heroin and fentanyl into the United States,” says Lynn Webster, MD, a pain management expert and past president of the American Academy of Pain Medicine.  “We need to remember 3 out of 4 drug overdoses do not involve a prescription opioid.  And most of the overdose deaths involving prescription opioids are not in people prescribed the medications.”

Webster is also concerned about a GAO recommendation that Medicare insurers be required to identify and report to CMS all high-dose opioid prescribers. Currently, there’s only a voluntary reporting system when doctors are investigated for fraud, waste or abuse.

“Investigating doctors who prescribe high dose opioids will have a chilling effect.  It will deter all providers from treating people with pain at any dose.  People will suffer.  There will be more suicides because of inadequately treated pain. This is not hyperbole,” said Webster. 

“The whole notion that reducing dose will solve the opioid crisis is misguided.  People who benefit from the high doses will be denied pain relief and those who use any dose for non-medical purposes will just seek illicit and more lethal drugs.”

Patients and Prescribers Ignored

Critics of the GAO report are also disturbed that the agency did not consult with any pain sufferers, patient advocacy organizations or professional medical organizations that represent prescribers. Instead, the GAO met primarily with insurance companies, regulators and addiction treatment specialists.

"We interviewed officials from the largest six health care plan sponsors: Aetna, Cigna, CVS Health, Express Scripts, Humana, and United Health Group," the GAO report says in a footnote.

"We also interviewed 12 stakeholders that represent a range of perspectives on opioid use and prescribing patterns in Medicare: AARP, American Health Insurance Plans, American Society of Interventional Pain Physicians, Brandeis Prescription Drug Monitoring Program Training and Technical Assistance Center, Federation of State Medical Boards, National Association of Drug Diversion Investigators, National Association of Medicaid Directors, National Healthcare Antifraud Association, Pew Charitable Trust, Pharmaceutical Care Management Association, Physicians for Responsible Opioid Prescribing (PROP), and one expert on opioid abuse."

The GAO would not identify any of the individuals it met with, saying the interviews were conducted on a “not for attribution” basis to encourage frank discussion. However, it seems likely that Andrew Kolodny, MD, was interviewed, as he is the founder and Executive Director of PROP, works at Brandeis University, and is considered by some to be an expert on opioid abuse.

Kolodny, who is the former chief medical officer of the addiction treatment chain Phoenix House, did not respond to a request for comment. Pain News Network is filing a request under the Freedom of Information Act with the GAO to disclose who they talked to.

“I find it very disturbing that federal agencies continue to ignore pain care providers and advocacy groups for people with pain when they formulate policies that very clearly will impact those parties. Again and again, they consult with parties that have a vested interest in reducing opioid prescribing regardless of the impact on people with pain," said Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.

“They even go so far as to invite one solo participant who is an ‘expert on opioid abuse.’ It’s as if they were asking representatives from the sugar industry to help develop guidelines on when artificial sweeteners should be used. Clearly, this speaks to a policy that is concerned with driving down opioid prescribing across the board, without considering the needs of the people with pain who actually benefit from opioid analgesics. It’s wrong, and everyone with a stake in pain management should demand that they start allowing us to sit at the table, rather than just to be on the menu.”

“It appears the GAO did not include patients, professional pain organizations and the American Medical Association in their deliberations. I would like to know how they feel their process can be justified,” added Webster. “They only invited groups to comment that appear to benefit financially from reduced prescribing or are opposed philosophically to opioids for non-cancer pain treatment.”

The only professional medical organization the GAO did consult with, the American Society of Interventional Pain Physicians, represents doctors who typically specialize in spinal injections and surgery.

The GAO’s Elizabeth Curda downplayed the role of people who were interviewed, telling PNN they were “not a major part of our methodology” in preparing the report.

Pain patients and pain management experts are often excluded or ignored when federal decisions are made about pain care.

The Centers for Disease Control and Prevention failed to consult with patients or practicing pain physicians while drafting its 2016 opioid prescribing guideline and secretly holding many of its deliberations.  The CDC also ignored a warning from its own consultant that some doctors stopped prescribing opioids after the guideline was issued.

Patients and doctors were also excluded from a closed door meeting of the Healthcare Fraud Prevention Partnership -- an obscure federal advisory group – when it met in "special session" last year to discuss Medicare's opioid prescribing policies. As PNN reported, major insurers like Aetna, Anthem, Cigna and Humana were invited to attend, but no other stakeholders in pain care were asked to appear or to share their insights.

More recently, President Trump’s opioid commission released its final report without taking any public testimony from pain sufferers, patient advocates or pain management physicians.