Below are some comments from a patient advocate in Nevada about changes to Medicare Part D in January 2019.
It contains, from Medicare: "A Prescriber's Guide" and a notice to insurers about 2019 Formulary-Level POS Safety Edits, which I find to have very important information.
I hope you find this information useful. I am sure most of you know about this already however the CMS newsletter is only a couple weeks old. At the Alliance for the Treatment of Intractable Pain, we are giving this information out to pain patients across the country. We are also trying to get the 2019 Call Letter edits suspended for 1 year.
A Prescriber's Guide to the New Medicare Part D Opioid Overutilizaton Policies for 2019
Page 3. 90mme is the threshold to ID potential high risk patients. Of significance, it says "This is not a prescribing limit"
Page 5. Palliative care is listed as one of the exemptions.
page 6. The patient, the patient’s representative, or the physician or other prescriber, on the patient’s behalf, has the right to request a coverage determination for a drug(s) subject to the alert, including the right to request an expedited or standard coverage determination in advance of prescribing an opioid
Page 6 How else can a provider prepare for the new 2019 Medicare Part D over-utilization policies? To avoid a prescription being rejected at the pharmacy, prescribes may proactively request a coverage determination in advance of prescribing an opioid prescription if the prescriber has assessed that the patient will need the full quantity written
So what does this all mean? Palliative care "should" be exempt.
Find out in advance if the Medicare plan will even have a safety edit at 200mme.
A hard edit at 200mme is optional for the insurance companies. Request a coverage
determination NOW. The patient can do this. It does not have to be the doctor.
Personally, I already have a PA for 2019. This "should" exclude me from having
a hard edit for above 200mme.
October 23, 2018 notice to sponsors
Additional Guidance on Contract Year 2019 Formulary Level Opioid POS Safety Edits
I include the above link as an attachment also.
MME hard edit (optional)
In 2019, sponsors will continue to have the flexibility to implement hard safety edits at a threshold of 200 MME or more, with or without prescriber/pharmacy counts. We remind sponsors that they may not use MME thresholds as prescribing limits. They can only function as a threshold to trigger the edit, indicating potentially unsafe opioid use.
I believe this is a significant statement.
If an enrollee or their prescriber requests a coverage determination and the only issue in dispute is the MME, CMS expects the Part D sponsor to approve the request if the prescriber attests that the higher MME is medically necessary, and not to apply additional requirements such as the execution of a pain management agreement.
It seems to me this is quite significant. The provider should be able, for instance, to just fax a copy
of this notice to the sponsor and simply say "I have reviewed the patient's history and attest the higher dose is medically necessary. End of discussion.
Q5: Which beneficiaries should be excluded from the opioid safety edits?
A5: Part D sponsors are expected to develop specifications that exclude beneficiaries who are residents of a long-term care facility, in hospice care or receiving palliative or end-of-life care, or being treated for active
cancer-related pain from all of the opioid safety edits. Sponsors should use all information available to them to reasonably exclude these beneficiaries from triggering the edits at POS in the first place.
(so should "someone" alert the sponsor in advance
that the patient is excluded because of say, palliative care?)
Sponsors should also apply specifications to account for known exceptions,
such as reasonable overlapping dispensing dates for prescription refills or new prescription orders for continuing fills; and high-dose opioid usage previously determined to be medically necessary such as through coverage determinations, prior authorization, case management, or appeal processes.
I've received a PA already through the end of 2019. Does
this mean I am excluded already? If everyone gets a PA, will it avoid the edit? FYI, my "Medicare and You" handbook lists 10 part-D sponsors. 4 of them
DO NOT list fentanyl patch 100mcg requiring a PA. ALL plans have an asterisk saying, "Opioid pain meds are subject to additional safety review"
Under question 6 answer:
Pharmacists are not expected to do extra work contacting prescribers or patients to find exclusions outside of the normal pharmacy workflow. Rather, pharmacists may have existing knowledge or information that a eneficiary is not opioid naïve or meets one of the opioid safety edit exclusions (such as through pharmacy drug claims history, knowledge of the enrollee’s diagnosis and/or the prescriber’s specialty).
Also, the pharmacist may learn through a care coordination consult with the prescriber that a beneficiary should be excluded. Sponsors should instruct pharmacists on how to communicate to the plan that the enrollee is excluded (e.g., through a transaction response code or by contacting the pharmacy help desk) to override the edit or to avoid the beneficiary or their prescriber from having to request a coverage determination on this particular fill. Plans are expected to accept this information in real-time so the claim can adjudicate.
so...........this implies to me, as my pharmacist already knows me and my history, he should already be checking with the sponsor and getting an override code.
Also in NV, the prescription is required to have the ICD code on it giving the pharmacist the information needed to get an override code from the sponsor.
Should the patient go to their pharmacist (with the notice?) and say "hey, please go ahead and get the override code now so we don't have to have a hassle in Jan. OK?
Are Part D sponsors permitted to require that specific criteria or requirements be met, such as a referral to a pain specialist, prior to approving a coverage determination request related to an opioid safety edit?
A7: No. The opioid safety edits are not intended to be a means to apply additional clinical criteria for the use of opioids, such as being managed by a pain specialist, having a signed pain contract, or having a treatment plan in place. In the absence of other submitted and approved utilization management requirements, the sponsor should allow the beneficiary to access his/her
medications once the prescriber(s) attests that the
identified cumulative MME level or days supply is the intended and medically necessary amount for the beneficiary.
medications once the prescriber(s) attests that the
identified cumulative MME level or days supply is the intended and medically necessary amount for the beneficiary.
This appears to me to limit the amount of hassle the sponsor/pharmacy can give the prescriber. This also re-affirms the comment from the other article saying "if MME is the only thing being considered" then the sponsor is suppose to accept the doctor's attestation that a high dose is medically necessary and should be approved.
CMS also expects sponsors to ensure that their staff are trained to appropriately identify and process enrollee requests for a coverage determination.
This includes verbal coverage determination requests made by enrollees, which should not be mis-classified as inquiries or grievances. Plans are not permitted to instruct an enrollee who is requesting a coverage determination that only their prescriber can initiate that request.
This includes verbal coverage determination requests made by enrollees, which should not be mis-classified as inquiries or grievances. Plans are not permitted to instruct an enrollee who is requesting a coverage determination that only their prescriber can initiate that request.
In other words, don't let the sponsor bullshit you. Fax them a copy of this newsletter. Give a copy to your pharmacist. Try to get your patients to request a coverage determination NOW. Enrollment ends Dec. 7th, 2018
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