The Centers for Medicare and Medicaid Services (CMS) will implement new safety rules on January 1 that could make it harder for over a million Medicare beneficiaries to get prescriptions filled for high doses of opioid pain medication.
Prescriptions for opioid “naïve” patients – those who are new to opioids — will also be limited to an initial 7-day supply, regardless of dose.
The new rules, which are modeled after the 2016 CDC opioid guideline, are intended to reduce the risk of opioid abuse and addiction.
Of course, they accomplish neither in real life.
They only apply to patients enrolled in Medicare’s Advantage and Part D prescription drug programs, and exempt patients in palliative and hospice care or those being treated for “active” cancer-related pain.
That sounds so reasonable and obvious, but even cancer patients are being denied opioids (links) in the real world.
But patients and advocates fear the rules give too much power to insurers and pharmacies, and could result in widespread confusion or patients being denied medications they’ve taken safely for years.
CMS contracts with dozens of private insurers to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid.
CMS policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.
‘Safety Edit’ for High Dose Prescriptions
Starting January 1, Medicare insurers will adopt drug management programs (DMPs) designed to flag patients who are deemed high risk – such as those who take opioids with anti-anxiety benzodiazepines or get opioid prescriptions from more than one doctor.
Any opioid prescription at or above 90 MME (morphine milligram equivalent) will trigger an automatic “safety edit” requiring pharmacists to talk with the prescribing doctor about the appropriateness of the dose.
If satisfied with the explanation or if a prior authorization was already granted, the pharmacist could override the safety edit and fill the prescription
I’m horrified that my pharmacist, who has no idea what specific pain my opioids are treating, could demand and then “not be satisfied” by my doctor’s explanation for a higher dose and choose not to fill my prescription.
About 1.6 million Medicare beneficiaries met or exceeded a dose of 90 MME in 2016.
Insurance companies can impose their own “hard edit” for patients getting 200 MME or more, which will require pharmacists to contact the insurer before filling a prescription
Insurers will also be given greater authority to identify patients at high risk of addiction and can even require they use “only selected prescribers or pharmacies.”
This isn’t even medical anymore. Pain patients are being treated as though we were all addicted to our prescription medication.
They regard us as not much different than people on methadone maintenance for opioid addiction, who have to go to a clinic every single day to be observed taking their daily dose of medication. That’s probably what they’d like us to do as well.
The bottom line for patients is that pharmacists and insurers – not doctors — could be the final arbiters of whether a prescription is appropriate and should be filled.
“If your Medicare drug plan decides your use of prescription opioids and benzodiazepines isn’t safe, the plan may limit your coverage of these drugs.”
This makes it sound as if “your Medicare drug plan” is an independent entity, now entitled to make decisions based on financial gain, not pain condition improvement.
“For example, under its DMP your plan may require you to get these medications only from certain doctors or pharmacies to better coordinate your health care.”
“The process they decided on — having pharmacists confer with prescribers — is really a good idea in the abstract, but in practice it’s going to be very burdensome,” says Bob Twillman, PhD, Executive Director of the Academy of Integrative Pain Management.
If a prescription is rejected by an insurer or pharmacist, patients have the option of paying for the medication in cash and/or filing an appeal.
But if you pay cash for opioids, that will register as a “red flag” and scare doctors away from prescribing you more.
“CMS officials have confirmed that Medicare prescription drug coverage involvement is limited to payment for medications. If a patient receives a denial of coverage, the patient has the right to pay out-of-pocket for that medication.
A Medicare denial only applies to financial coverage. It has no authority to deny the prescription itself,” says Andrea Anderson, Executive Director of the Alliance for the Treatment of Intractable Pain (ATIP).
ATIP is encouraging patients denied medication to contact a little-known CMS agency called the Beneficiary and Family Centered Care-Quality Improvement Program, where they can file an appeal or make a complaint.
Medicare patients can also be proactive by talking with their doctor and pharmacist about the new rules before getting a prescription filled. They can also seek a prior authorization from their insurer to avoid the delays of a safety edit at the pharmacy.