Happy New Year CMS, Buprenorphine and Tapentadol

As many of you
already know, the Centers for Medicare & Medicaid Services (CMS) has
established new policies that will be implemented January 1, 2019 around opioid
prescribing. They call this their “three-pronged approach to combating the
opioid epidemic” and it includes the following:

1. prevention
   of new cases of opioid use disorder
   (OUD)
2. treatment
   of patients who have already become dependent on or addicted to opioids; and
3. utilization
   of data from across the country to better target prevention and treatment
   activities.

The imperceptiveness
of “…strengthen and broaden our partnership with providers” is uncanny to say
the least.  More likely than not, this
new policy will drive a wedge between dispensing pharmacists and prescribing
clinicians with the heart of long-term opioid patients square in the middle of
a sharp blade.

According to their Prescriber’s Guide to the New Medicare Part D Opioid Overutilization Policies for 2019, available HERE, through their “2019 Medicare Part D opioid overutilization initiatives, CMS seeks to strengthen and broaden our partnership with providers to address the opioid crisis.”

With clearly
diminished opioid prescribing and dose reduction in almost every state, we’ve
seen consistent rises in opioid deaths; some by suicide of suffering patients;
some from legitimate patients seeking illicit opioids because they are unable
to obtain them from their medical provider; and some from addicts who are
overdosing on heroin laced with fentanyl analogues (not to be confused with
pharmaceutical fentanyl).

To review, here’s
what the new policies will require, copied directly from the above link…

Specific to prescription opioids, beginning
in January 2019, Medicare Part D plans will employ the following new safety
alerts at the pharmacy:

7-day supply limit for opioid naïve patients:
Part D plans are expected to implement a hard safety edit to limit initial
dispensing to a supply of 7 days or less. A hard safety edit stops the pharmacy
from processing a prescription until an override is entered or authorized by
the plan.

CMS’ goal with this policy is to reduce the
potential for chronic opioid misuse through closer management of opioid naïve
patients. Clinical evidence cited by the Centers for Disease Control and
Prevention (CDC) found that opioid use for acute pain is associated with
long-term opioid use and that a greater amount of early opioid exposure is
associated with greater risk for long-term use. Recommendation 6 of the CDC Guideline
states that opioids prescribed for acute pain should be limited to 3 days or
fewer, and that more than a 7-day supply is rarely necessary. Limiting the
amount dispensed with the first opioid prescription may reduce the risk of
patients developing a future dependency or overuse of these drugs.

A pharmacist can dispense partial quantities
of an opioid prescription consistent with state and federal regulations.
However, if a prescriber believes that an opioid naïve patient will need more
than a 7-day supply initially, the provider can proactively request a coverage
determination on behalf of the patient attesting to the medical need for a
supply greater than 7 days. Additionally, if a provider assesses upon
re-evaluation that a patient will need additional opioid therapy, subsequent
prescriptions will not be subject to the 7-day supply limit, as the patient
will no longer be considered opioid naive.

Opioid care coordination alert:
This policy will affect Medicare patients when they present an opioid prescription
at the pharmacy and their cumulative morphine milligram equivalent (MME) per
day across all of their opioid prescription(s) reaches or exceeds 90 MME.
Regardless of whether individual prescription(s) are written below
the threshold, the alert will be triggered by the fill of the prescription that
reaches the cumulative threshold of 90 MME or greater. It is the prescriber who
writes the prescription that triggers the alert who will be contacted by the
pharmacy even if that prescription itself is below the 90 MME threshold.

This safety alert includes a 90 MME threshold
for identifying potentially high risk patients who may benefit from closer
monitoring and care coordination. 90 MME is cited in the CDC Guideline as the
level above which prescribers should generally avoid. This is not a prescribing
limit. In reviewing the alert, the pharmacist may need to consult with the
prescriber to confirm medical need for the higher MME. The pharmacist can then
indicate that the prescriber was consulted so the prescription claim can pay.

The care coordination safety alert is a
proactive step to give prescribers more information, and if warranted, to
encourage prescribers to emphasize opioid overdose risk and prevention with
their patients, especially if the patient is receiving prescription opioids
from multiple prescribers or pharmacies.

Will the pharmacy call the provider every
time a patient has an opioid prescription that reaches or exceeds 90 MME for
the care coordination safety alert?

No. The provider will be initially contacted
by the pharmacist if a patient presents to the pharmacy with a prescription
that reaches a cumulative threshold of 90 MME or greater across all of the
patient’s opioid prescriptions and triggers the alert at the pharmacy. Once a
pharmacist consults with a prescriber on a patient’s prescription for a plan
year, the pharmacist does not have to consult with the prescriber on every
opioid prescription written for the same patient after that unless the plan
implements further restrictions. For example, Part D plans also have the option
to set an additional alert that stops a prescription from being filled at the
pharmacy if the opioid threshold reaches 200 MME or greater and may
additionally include prescriber and pharmacy counts.

There are of course many issues here. The statement “For example, Part D plans also have the option to set an additional alert that stops a prescription from being filled…” concerns me because I believe that insurance providers that partner with Medicare will exercise carte blanche and treat this as an avenue to halt coverage on any opioids more expensive than the more abusable generics; I suspect they will attempt to limit payment for or require higher copays for many of the extended release opioids, abuse deterrent formulations, buprenorphine, and tapentadol. Pharma will likely respond with direct to patient discount cards, and will be forced to deal with the devil, PBMs to gain favor for coverage.

Prescribers and pharmacists will likely not have the time to duck patient care responsibilities to make these calls to each other, and if they try, experience tells me it will be a game of telephone tag. Both pharmacists and prescribers will likely avoid prior authorizations at all costs which will result in drastically lowered opioid dosing and rapid tapering, as covered in a previous blog, If You are Forced to Stop Opioids. Regarding the 7-day limitation, I believe that, in many cases, by the time a prior authorization is approved for opioids beyond the 7-day limit, the acute pain phase will likely have passed, unless CMS mandates that their private sector contracted insurance providers have a quick turnaround with implemented penalties to the insurers – don’t hold your breath. 

CMS should mandate
that insurance carriers not disincentivize (by requiring higher copays) or reject
buprenrophine (Belbuca and Butrans) in favor of any full agonist opioid for new
patients just because of cost. I have seen many insurance companies deny these
in lieu of full agonist opioids (including morphine, methadone, fentanyl
transdermal, and others). Where’s the forthright safety concern there?

In fact, a previous blog, Insurance Companies, Learned Helplessness, and Opioid Deaths, outlined one example of a real case where tramadol ER was rejected in favor of first failing methadone, morphine ER, or Oxycodone ER. I wonder if failing these drugs includes death.

Since CMS refers to the CDC Guidelines as a gospel of sorts, they should also require that tapentadol (Nucynta) be a formulary item and prescribed in advance of traditional full agonist opioids, at least for chronic pain. In fact, the CDC’s CALCULATING TOTAL DAILY DOSE OF OPIOIDS FOR SAFER DOSAGE makes no mention of an MME for either buprenorphine or tapentadol, and for good reason… There isn’t one. For more info on that, see Academy of Integrative Pain Medicine’s White Paper, Opioid Dosing Policy: Pharmacological Considerations Regarding Equianalgesic Dosing which clearly delineates the fallacy of morphine daily equivalents, especially with buprenorphine and tapentadol.

If all other
non-opioid options and non-medication alternatives have been exhausted, and a
careful, rational decision has been made to begin opioids following risk
stratification, my recommendation to providers that want to stay off the CMS
morphine milligram equivalent (MME) radar for new patients requiring long-term
opioid therapy is to start with buprenorphine first because it has a ceiling
effect on CO2 accumulation. It also disallows full agonist opioids to hog up mu-receptors,
and once buprenorphine occupies those receptors, it is difficult for the full
agonist to find an unoccupied mu-opioid receptor. Buprenorphine in that regard
is like a game of musical chairs, where all chairs (aka mu-receptors) are occupied
by buprenorphine, and the person that gets bumped when the music stops is the
full agonist opioid. For this reason, buprenorphine overtakes the receptors but
can still offer analgesia similar to or better than the full agonists being displaced.
Next choice is tapentadol because the dual mechanism offers excellent analgesia
at a finite dose with reduced toxicity. 
Only after these should a traditional full agonist opioid ever be considered,
and if CMS is really concerned about misuse, an abuse deterrent formulation
should be favored – this won’t happen if CMS allows their contracted providers
to implement their own rules, as is this case now. Afterall, the new CMS policy
upfront and center sates, as seen in #1 above, “prevention of new cases of opioid use disorder (OUD)”.
Assuming that CMS is actually troubled about safety, they should include this
as part of their policy. Moreover, in terms of safety, the CDC Guidelines
encourage the use of in-home naloxone, especially when titrating or converting from
one or more opioids to another.  Where is
the CMS recommendation of a requirement to provide, train, and pay for FDA
approved in-home naloxone?  Surely if
they are mostly concerned about safety over cost, this should be included in
the new policy, right?

I am fervently in
favor of opioid policies that are evidence-based and will transparently improve
safety. I believe that the new CMS policy, while presumably well-intended, will
make the opioid crisis worse both in terms of opioid-related deaths (legal and
illicit) and for patients that truly require long-term opioid therapy that will
end up bedridden, depressed, and suicidal.

I usually would close
this by wishing all of you a Healthy and Happy New Year, and although I do wish
this for all our readers, good luck with that!

As always, comments are welcome!